Product Pharmacovigilance
Explore all topics, guides, and frameworks related to Product Pharmacovigilance.
Articles in this section
198- Semaglutide: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Semaglutide is a long-acting glucagon-like peptide-1 receptor agonist produced by recombinant DNA technology in yeast and modified to extend exposure through albumin binding. It is marketed in distinct products for type 2 diabetes and weight management. Its effects include glucose-dependent stimulation of insulin secretion, suppression of glucagon when glucose is elevated, delayed gastric emptying and reduced energy intake. The dominant safety architecture connects product and dose escalation to gastrointestinal intolerance, hydration and renal consequences, pancreatitis and gallbladder assessment, hypoglycaemia with insulin or sulfonylureas, diabetic-retinopathy risk context and emerging product-information updates such as NAION. Read Article →
- Atorvastatin: Discovery, Cardiovascular Development, Safety and Pharmacovigilance Atorvastatin is a synthetic HMG-CoA reductase inhibitor whose development progressed from LDL-cholesterol lowering to prevention of cardiovascular events. This article traces its discovery and commercial history, pivotal positive and negative studies, regional authorisation distinctions and evolving safety evidence. It explains how to distinguish common muscle symptoms from rhabdomyolysis, immune-mediated necrotising myopathy and myasthenia, and how to reconstruct exposure, interactions and clinically useful safety reports. Read Article →
- Zolbetuximab: Mechanism, Clinical Safety and Pharmacovigilance Zolbetuximab is a chimeric IgG1 monoclonal antibody targeting CLDN18.2 in selected HER2-negative gastric or gastro-oesophageal junction adenocarcinoma. This article explains biomarker-based eligibility, its immune-effector mechanism, the fluoropyrimidine/platinum treatment context, early-cycle nausea and vomiting, and how pharmacovigilance should separate antibody, chemotherapy and disease contributions. Read Article →
- Zilganersen: From GFAP Antisense Discovery to the First Approved Treatment for Alexander Disease Zilganersen is an intrathecal antisense oligonucleotide that reduces GFAP pre-mRNA and was approved by the FDA in September 2026 for pediatric and adult patients with Alexander disease. Its development links decades of GFAP biology with antisense technology, an ultra-rare pivotal programme, clinically meaningful motor-function evidence, aseptic meningitis and CSF inflammatory findings, immunogenicity, and a substantial postmarketing evidence programme. Read Article →
- Zanidatamab: Mechanism, Clinical Safety and Pharmacovigilance Zanidatamab is a biparatopic HER2-directed antibody conditionally authorised in the EU for previously treated, unresectable or metastatic biliary tract cancer with HER2 IHC 3+ expression. This article links receptor clustering with biomarker traceability, biweekly infusion, diarrhoea and cardiac surveillance. Read Article →
- Vilobelimab: Selective C5a Neutralisation in COVID-19-Associated ARDS Vilobelimab is a monoclonal antibody that neutralises C5a, a pro-inflammatory complement mediator, while leaving C5b formation available for the terminal complement pathway. Its EU-authorised use is narrow: SARS-CoV-2-induced ARDS in adults receiving corticosteroids and invasive mechanical ventilation. Severe illness, treatment timing and concomitant ICU care are central to case assessment. Read Article →
- Vedolizumab: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Vedolizumab is a humanised IgG1 monoclonal antibody that binds α4β7 integrin and limits gut-directed lymphocyte trafficking. This article explains how its target, route, indication and product context shape pharmacovigilance assessment. Read Article →
- Ustekinumab: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Ustekinumab is a fully human IgG1 kappa monoclonal antibody against the p40 subunit shared by interleukin-12 and interleukin-23. This parent molecule article explains why one target affects two cytokine pathways, how that mechanism supports use across skin, joint and intestinal disease, how the product's indication and route evolved over time, and how long-term pharmacovigilance should distinguish molecule-level safety from biosimilar and interchangeability questions covered separately. Read Article →
- Vaccines: Classification and Pharmacovigilance Understand how vaccines are classified, how vaccine composition and platform influence safety surveillance, and how product-specific pharmacovigilance operates within the wider EU pharmacovigilance system. Read Article →
- Ustekinumab Biosimilars: IL-12/23 Biology, Interchangeability and Product Pharmacovigilance Ustekinumab binds the shared p40 subunit of IL-12 and IL-23. This article explains how that biology relates to psoriasis, psoriatic arthritis and inflammatory bowel disease, how biosimilarity is demonstrated, why US interchangeability has a specific regulatory meaning, and how traceability and switching history shape pharmacovigilance. Read Article →
- Ublituximab: Mechanism, Clinical Safety and Pharmacovigilance Ublituximab is a chimeric anti-CD20 monoclonal antibody authorised in the EU for adults with active relapsing multiple sclerosis. This article explains its mechanism, treatment schedule and key safety issues, then shows how pharmacovigilance can distinguish infusion reactions, infection, possible progressive multifocal leukoencephalopathy and disease activity. Read Article →
- Trastuzumab and Hyaluronidase Subcutaneous Formulation: Administration, Safety and Pharmacovigilance Explains how the subcutaneous trastuzumab-hyaluronidase formulation differs operationally and pharmacovigilance-wise from intravenous trastuzumab while retaining the parent molecule's HER2-directed biology. Read Article →
- Tremelimumab: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Tremelimumab is a fully human IgG2 monoclonal antibody targeting CTLA-4. By blocking an inhibitory checkpoint that constrains early T-cell activation, it amplifies antitumour immune priming. Current EU use is in combination with durvalumab, so pharmacovigilance must distinguish the biological contribution of CTLA-4 blockade while assessing the clinical regimen as a whole. Read Article →
- Trastuzumab: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Trastuzumab is a humanised IgG1 monoclonal antibody directed against subdomain IV of the HER2 extracellular domain. Its development converted HER2 amplification from a marker of aggressive cancer into a therapeutically actionable biomarker. This article explains trastuzumab’s structure, target biology, direct and immune-mediated mechanisms, clinical development, resistance, major safety risks and the product-, regimen- and time-specific controls required for effective pharmacovigilance. Read Article →
- Trastuzumab Deruxtecan: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Trastuzumab deruxtecan is a HER2-directed antibody-drug conjugate composed of a trastuzumab-derived antibody, a cleavable linker and a membrane-permeable topoisomerase-I inhibitor payload. This article explains why target expression, internalisation, payload release and bystander killing must be considered together, and why interstitial lung disease/pneumonitis is a defining pharmacovigilance priority. Read Article →
- Trastuzumab Emtansine: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Trastuzumab emtansine is a HER2-directed antibody-drug conjugate in which trastuzumab is linked through a stable non-cleavable linker to the maytansinoid microtubule inhibitor DM1. Its safety profile cannot be inferred from trastuzumab alone because toxicity reflects the antibody, linker, payload, target biology and intracellular processing. This article explains that integrated pharmacology and translates it into product-specific case assessment, signal detection, aggregate review and risk management. Read Article →
- Tralokinumab: Mechanism, Clinical Safety and Pharmacovigilance Tralokinumab is a monoclonal antibody that neutralises IL-13 for systemic treatment of moderate-to-severe atopic dermatitis. This article explains how target biology, the underlying skin disease and treatment context inform case assessment, follow-up and aggregate review. Read Article →
- Toripalimab: Mechanism, Clinical Safety and Pharmacovigilance Toripalimab is a humanised anti-PD-1 monoclonal antibody authorised in the EU with chemotherapy for defined adult nasopharyngeal and oesophageal squamous-cell cancers. This article connects its immune checkpoint mechanism with treatment-specific safety assessment, immune-related adverse reactions and practical case evaluation. Read Article →
- Tocilizumab: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Tocilizumab is a humanised IgG1 monoclonal antibody directed against the interleukin-6 receptor. By blocking both soluble and membrane IL-6 receptor signalling, it suppresses inflammatory pathways used across rheumatoid arthritis, juvenile inflammatory disease, giant cell arteritis, cytokine release syndrome and selected other indications. This article links that biology to its distinctive pharmacovigilance profile, including serious infection, gastrointestinal perforation, hepatotoxicity, neutropenia, thrombocytopenia, altered inflammatory markers, hypersensitivity, treatment-context differences and product traceability. Read Article →
- Topical Bovine Thrombin: Haemostasis, Immunogenicity and Pharmacovigilance Topical bovine thrombin accelerates local fibrin formation during surgery but can induce antibodies to bovine thrombin and factor V. Cross-reactive anti-factor-V antibodies can produce clinically important coagulopathy, making prior surgical exposure and immune history central pharmacovigilance variables. Read Article →
- Tixagevimab and Cilgavimab: Classification, History, Mechanism, Safety and Pharmacovigilance Tixagevimab and cilgavimab are two long-acting monoclonal antibodies that bind non-overlapping regions of the SARS-CoV-2 spike receptor-binding domain. Their lifecycle demonstrates an unusual pharmacovigilance problem: an antibody can retain its molecular identity and tolerability profile while losing clinical usefulness as a viral target evolves. Read Article →
- Tildrakizumab: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Tildrakizumab is a humanised IgG1Îş monoclonal antibody that selectively binds the p19 subunit of interleukin-23. Its long-interval subcutaneous use and psoriasis context require pharmacovigilance that preserves treatment phase, infection assessment, disease activity, immunogenicity and product traceability. Read Article →
- Tirzepatide: Discovery, Dual Incretin Pharmacology, Clinical Development and Pharmacovigilance Tirzepatide is a long-acting synthetic peptide that activates GIP and GLP-1 receptors. Its development links metabolic efficacy with gastrointestinal tolerability, changing populations and product-specific risk management. This review follows discovery, pivotal and outcome studies, commercial expansion, regional differences in product information and the reconstruction of clinically useful safety reports. Read Article →
- Tislelizumab: Mechanism, Clinical Safety and Pharmacovigilance Tislelizumab is an anti-PD-1 monoclonal antibody used in selected EU-labeled lung, upper gastrointestinal and nasopharyngeal cancers. This article links indication and combination conditions with immune-mediated events, delayed presentation, corticosteroid management and case reconstruction. Read Article →
- Tezepelumab: TSLP Biology, Severe Asthma, CRSwNP and Product Pharmacovigilance Tezepelumab blocks thymic stromal lymphopoietin (TSLP), an epithelial alarmin upstream of several inflammatory pathways. This article explains how that biology links to severe asthma, chronic rhinosinusitis with nasal polyps, treatment selection and mechanism-informed pharmacovigilance. Read Article →
- Tick-Borne Encephalitis Vaccine: Inactivated-Virus Biology, Immunisation and Pharmacovigilance The tick-borne encephalitis vaccine is a formaldehyde-inactivated whole-virus vaccine adsorbed to aluminium hydroxide. Pharmacovigilance depends on exact age presentation, completion of the multi-dose series, exposure geography, breakthrough-disease confirmation and lot traceability. Read Article →
- Teprotumumab: IGF-1 receptor biology, thyroid eye disease, and product pharmacovigilance Teprotumumab blocks the insulin-like growth factor 1 receptor. This article connects receptor structure to thyroid eye disease, clinical benefit, treatment placement, and mechanism-informed safety surveillance. Read Article →
- Teplizumab: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Teplizumab is a Fc-receptor-non-binding anti-CD3 monoclonal antibody directed against CD3 on mature T lymphocytes. Its effect is modulating pathogenic T-cell activity and preserving endogenous beta-cell function in selected type 1 diabetes settings. This article explains how the mechanism and treatment context shape case assessment, signal detection, risk management and periodic benefit-risk evaluation. Read Article →
- Tarlatamab: DLL3Ă—CD3 T-Cell Engagement, Small-Cell Lung Cancer and Product Pharmacovigilance Tarlatamab is a DLL3-directed CD3 T-cell engager that redirects T cells against small-cell lung cancer. This article explains why DLL3 is a useful lineage-associated target, how bispecific immune synapses produce both tumour killing and cytokine-mediated toxicity, and how step-up dosing, prolonged early-cycle monitoring and syndrome-specific pharmacovigilance manage CRS and neurologic risk. Read Article →
- Teclistamab: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Teclistamab is a humanised IgG4-PAA bispecific antibody that binds BCMA on plasma cells and CD3 on T cells. This article explains how immune-synapse formation produces antimyeloma activity and also creates cytokine-release and neurotoxicity risks, why BCMA-directed treatment affects normal humoral immunity, and why dose sequence, baseline immune fitness and monotherapy versus combination treatment are essential pharmacovigilance variables. Read Article →
- Talimogene Laherparepvec: Oncolytic HSV-1, Melanoma and Product Pharmacovigilance Talimogene laherparepvec is a genetically modified herpes simplex virus type 1 designed to replicate preferentially in tumour tissue and express GM-CSF. This article explains how viral engineering creates local antitumour activity, why handling and exposure controls are part of product safety, and how infection, immune-mediated events and lesion complications should be assessed. Read Article →
- Talquetamab: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Talquetamab is a humanised IgG4-PAA bispecific antibody that binds GPRC5D on myeloma cells and CD3 on T cells. This article explains how GPRC5D provides an alternative plasma-cell target to BCMA, how T-cell redirection creates CRS and neurotoxicity risk, and why normal GPRC5D expression in keratinised and oral tissues produces a distinctive pattern of dysgeusia, dry mouth, dysphagia, skin and nail toxicity and weight loss that requires dedicated pharmacovigilance. Read Article →
- Tafasitamab: Mechanism, Clinical Safety and Pharmacovigilance Tafasitamab is a CD19-directed monoclonal antibody used in defined relapsed or refractory B-cell lymphoma regimens. This article explains how the indication and treatment phase shape exposure attribution, follow-up and aggregate safety review. Read Article →
- Taliglucerase Alfa: Plant-Cell Recombinant Enzyme Replacement in Gaucher Disease and Pharmacovigilance Taliglucerase alfa is a recombinant human glucocerebrosidase produced in genetically modified carrot cells and used as enzyme replacement therapy for type 1 Gaucher disease. Its pharmacovigilance combines infusion and immunogenicity surveillance with longitudinal assessment of disease manifestations and treatment response. Read Article →
- Sutimlimab: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Sutimlimab is a humanised IgG4 monoclonal antibody directed against C1s. Its effect is selectively inhibiting C1s and classical complement-pathway activation. This article explains how the mechanism and treatment context shape case assessment, signal detection, risk management and periodic benefit-risk evaluation. Read Article →
- Somatropin: Classification, Growth Hormone Biology, Safety and Pharmacovigilance Somatropin is recombinant human growth hormone. Its pharmacovigilance requires longitudinal interpretation of growth response, IGF-1, glucose and thyroid/adrenal physiology, neurological and orthopaedic symptoms, indication-specific risks, adherence, injection technique and device performance. Read Article →
- Spesolimab: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Spesolimab is a humanised IgG1 monoclonal antibody directed against the interleukin-36 receptor. This article explains how its target, route and clinical context shape case assessment, signal detection, risk management and periodic benefit-risk evaluation. Read Article →
- Siltuximab: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Siltuximab is a chimeric monoclonal antibody that binds interleukin-6 rather than the IL-6 receptor. Its authorised use in HIV-negative, HHV-8-negative multicentric Castleman disease provides a focused example of cytokine-driven disease, where IL-6 neutralisation can reduce systemic inflammation and lymph-node pathology but requires careful surveillance for infection, infusion reactions and laboratory abnormalities. Read Article →
- Sipavibart: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Sipavibart is a long-acting human IgG1 monoclonal antibody that provides passive pre-exposure prophylaxis against susceptible SARS-CoV-2 variants in immunocompromised adults and adolescents. This article explains why circulating-variant susceptibility is part of the medicine's benefit-risk profile, how spike mutations such as F456L can markedly reduce neutralisation, and how pharmacovigilance must distinguish breakthrough infection, resistance, administration reactions and emerging safety signals. Read Article →
- Somatrogon: Classification, Mechanism, Growth Hormone Use and Pharmacovigilance Somatrogon extends growth-hormone exposure through fusion-protein engineering, allowing once-weekly administration in paediatric growth hormone deficiency. Its pharmacovigilance combines class-wide growth-hormone risks with formulation-specific questions around weekly dosing, injection devices, adherence and long-term growth response. Read Article →
- Signal Management for Biological Medicinal Products This article explains the complete signal-management lifecycle for biological medicines and shows how target/class effects, active-substance evidence, product and batch identity, manufacturing change, immunogenicity, formulation, device and biosimilar switching alter detection and assessment. A continuing monoclonal-antibody example demonstrates decisions from first observation to closure. Read Article →
- Satralizumab: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Satralizumab is a humanised IgG2 monoclonal antibody engineered for pH-dependent binding to the interleukin-6 receptor and enhanced FcRn-mediated recycling. It is used in AQP4-IgG-seropositive neuromyelitis optica spectrum disorder, either alone or with immunosuppressive therapy in the EU. This article explains NMOSD biology, the role of IL-6 in plasmablast survival and blood-brain-barrier inflammation, recycling-antibody engineering and subcutaneous pharmacology, then connects those concepts to infection, liver-enzyme elevations, neutropenia, hypersensitivity, vaccination, pregnancy, relapse interpretation and longitudinal pharmacovigilance. Read Article →
- Secukinumab: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Secukinumab is a fully human monoclonal antibody that neutralises interleukin-17A. This article explains how IL-17A links barrier immunity with chronic inflammatory disease, why the same mechanism that improves psoriasis and spondyloarthritis can alter mucosal host defence and intestinal inflammation, and how indication, age, concomitant immunosuppression and treatment chronology shape pharmacovigilance. Read Article →
- Sarilumab: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Sarilumab is a fully human IgG1 monoclonal antibody directed against IL-6 receptor (IL-6R). Its effect is binding soluble and membrane-bound IL-6R and inhibiting IL-6 signalling. This article explains how the mechanism and treatment context shape case assessment, signal detection, risk management and periodic benefit-risk evaluation. Read Article →
- Romosozumab: Sclerostin–Wnt Biology, Bone Formation, Fracture Prevention, Cardiovascular Safety and Product Pharmacovigilance Romosozumab is a humanised IgG2 monoclonal antibody that neutralises sclerostin, an osteocyte-derived extracellular brake on canonical Wnt signalling. Removing that brake produces an early increase in bone formation together with reduced bone resorption. The resulting rapid fracture benefit is clinically important in selected postmenopausal women at very high fracture risk, but treatment is limited to 12 monthly doses, requires prompt antiresorptive follow-on therapy, and demands explicit cardiovascular, calcium and oral-health risk management. Read Article →
- Rozanolixizumab: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Rozanolixizumab is a humanised monoclonal antibody designed to block the neonatal Fc receptor (FcRn). This article explains how its target, route and clinical context shape case assessment, signal detection, risk management and periodic benefit-risk evaluation. Read Article →
- Sacituzumab govitecan: Mechanism, Clinical Safety and Pharmacovigilance Sacituzumab govitecan links a Trop-2-directed antibody to SN-38. This article covers four EU-labeled breast-cancer settings, including selected first-line use with pembrolizumab, and connects day 1/day 8 exposure with marrow and gastrointestinal toxicity and UGT1A1-associated vulnerability. Read Article →
- Romiplostim: thrombopoietin receptor biology, immune thrombocytopenia, and product pharmacovigilance Romiplostim is a thrombopoietin-receptor agonist that increases platelet production rather than directly suppressing the immune process that causes ITP. This article connects platelet biology, peptibody structure, treatment response, and the safety signals that matter in pharmacovigilance. Read Article →
- Rituximab: Classification, History, Mechanism of Action and Pharmacovigilance Rituximab is a chimeric type I anti-CD20 IgG1 monoclonal antibody that transformed B-cell lymphoma treatment and subsequently became an important therapy for rheumatoid arthritis, ANCA-associated vasculitis and pemphigus vulgaris. This article explains its structure, development, target biology, multiple interacting effector mechanisms, clinical and regulatory history, major risks, and the pharmacovigilance controls required across indications, formulations and product brands. Read Article →
- Rituximab and Hyaluronidase Subcutaneous Formulation: Safety and Pharmacovigilance Explains how the subcutaneous rituximab-hyaluronidase presentation differs from intravenous rituximab and why the IV lead-in, product identity and route-specific safety require separate pharmacovigilance controls. Read Article →
- Risankizumab: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Risankizumab is a humanised IgG1 monoclonal antibody directed against the p19 subunit of interleukin-23. This article explains how its target, route and clinical context shape case assessment, signal detection, risk management and periodic benefit-risk evaluation. Read Article →
- Reslizumab: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Reslizumab is a humanised IgG4Îş monoclonal antibody that neutralises interleukin-5. This article explains how eosinophil biology, weight-based intravenous dosing, anaphylaxis and asthma background risk shape pharmacovigilance. Read Article →
- Respiratory Syncytial Virus Vaccine (Bivalent, Recombinant): Biology, Maternal Immunisation and Pharmacovigilance The bivalent recombinant RSV vaccine contains stabilised prefusion F antigens from RSV A and B. Pharmacovigilance must distinguish active immunity in adults from maternal vaccination that protects infants through transferred antibody, while preserving gestational timing, pregnancy and birth outcomes, neurological events, vaccine co-administration and lot traceability. Read Article →
- Retifanlimab: PD-1 Blockade Across Merkel Cell and Anal Canal Carcinomas Retifanlimab is a humanised IgG4 monoclonal antibody that blocks PD-1. Its EU indications include first-line treatment of advanced Merkel cell carcinoma and combination treatment for advanced squamous cell carcinoma of the anal canal. Pharmacovigilance must distinguish the monotherapy and chemotherapy-combination contexts and assess delayed immune-mediated toxicity. Read Article →
- Relatlimab: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Relatlimab is a human IgG4 monoclonal antibody directed against lymphocyte-activation gene 3 (LAG-3) and is authorised in a fixed-dose combination with nivolumab. Blocking two inhibitory pathways creates a distinct exposure context rather than two independent monotherapies. This article explains LAG-3 biology, combination attribution, immune-mediated adverse reactions, infusion reactions, risk management and product traceability. Read Article →
- Recombinant Therapeutic Proteins: Classification and Pharmacovigilance Understand how recombinant therapeutic proteins are classified and developed, how structure and biological function influence their safety, and how these characteristics shape pharmacovigilance across the product lifecycle. Read Article →
- Recombinant Factor VIII: Classification, History, Mechanism of Action, Inhibitors and Pharmacovigilance Recombinant factor VIII (rFVIII) products replace the missing or dysfunctional coagulation cofactor in haemophilia A. They range from standard half-life full-length and B-domain-deleted proteins to Fc-fused, albumin-fused and PEGylated extended-half-life molecules. All support activated factor IX in the intrinsic tenase complex, but their molecular design, pharmacokinetics, assay behaviour, immunogenicity and product-specific information differ. Inhibitor formation is the central treatment complication; rigorous pharmacovigilance must reconstruct the product–exposure-day–recovery–bleeding trajectory rather than treat breakthrough bleeding as a simple adverse-event label. Read Article →
- Receptor-Directed Monoclonal Antibodies: Receptor Blockade, Modulation and Pharmacovigilance Understand how receptor-directed monoclonal antibodies alter receptor signalling, how representative products illustrate different intervention points, and how receptor biology, exposure and immunogenicity shape pharmacovigilance. Read Article →
- Ranibizumab: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Ranibizumab is a humanised monoclonal-antibody Fab fragment that neutralises biologically active VEGF-A isoforms and is administered by intravitreal injection for neovascular and oedematous retinal disease. Unlike a full IgG antibody, it contains no Fc region and was designed for local ocular exposure and rapid systemic clearance. This article explains VEGF-dependent retinal pathology, Fab-fragment structure, ocular pharmacology and indication differences, then connects those concepts to injection-related endophthalmitis, intraocular inflammation, retinal tear or detachment, traumatic cataract, intraocular-pressure changes, arterial thromboembolic considerations, bilateral treatment, biosimilar traceability and practical pharmacovigilance. Read Article →
- Ranibizumab Port-Delivery Implant: Device, Safety and Pharmacovigilance The ranibizumab port-delivery implant changes anti-VEGF treatment from repeated standalone injections to a permanent ocular implant that is surgically inserted and periodically refilled. Safety therefore arises from ranibizumab pharmacology, implant presence, surgery, refill-exchange technique and device integrity. This article develops that combined product-device pharmacovigilance model and its implications for case assessment, signal detection and governance. Read Article →
- Ravulizumab: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Ravulizumab is a long-acting humanised monoclonal antibody that blocks complement protein C5. This article explains how molecular engineering extended the dosing interval relative to eculizumab, why the same terminal-complement mechanism treats several diseases but creates a shared susceptibility to meningococcal infection, and how indication, treatment interruption and switching shape pharmacovigilance. Read Article →
- Ramucirumab: Mechanism, Clinical Safety and Pharmacovigilance Ramucirumab is a human IgG1 monoclonal antibody that blocks VEGFR2 and is authorised in several advanced cancer settings. This article explains why hypertension, bleeding, arterial events, gastrointestinal perforation and impaired wound healing are central to its pharmacovigilance profile. Read Article →
- Pneumococcal Polysaccharide Conjugate Vaccine (20-Valent): Biology, Serotype Coverage and Pharmacovigilance The 20-valent pneumococcal conjugate vaccine links purified capsular polysaccharides from 20 Streptococcus pneumoniae serotypes to CRM197 and adsorbs them on aluminium phosphate. Pharmacovigilance must distinguish expected reactogenicity from serious events while preserving age, schedule, prior pneumococcal vaccination, serotype, co-administration and lot information for vaccine-failure and safety assessment. Read Article →
- Polatuzumab Vedotin: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Polatuzumab vedotin is a CD79b-directed antibody-drug conjugate that delivers the microtubule inhibitor monomethyl auristatin E to B cells. Its safety profile reflects target expression, linker-payload pharmacology, intracellular processing and combination-regimen toxicity. This article explains the molecule progressively and translates that biology into case assessment, signal detection and practical pharmacovigilance. Read Article →
- Plasma-Derived Medicinal Products: Classification and Pharmacovigilance Understand how plasma-derived medicinal products are classified, how plasma collection and fractionation shape product characteristics, and how these characteristics influence pharmacovigilance, traceability and safety surveillance. Read Article →
- 13-Valent Pneumococcal Conjugate Vaccine: Immunology, Serotype Coverage and Pharmacovigilance The 13-valent pneumococcal conjugate vaccine links capsular polysaccharides from 13 pneumococcal serotypes to CRM197 to generate T-cell-dependent immune responses. Its pharmacovigilance requires precise product, age, schedule and serotype information, particularly as higher-valency pneumococcal vaccines coexist with or replace earlier products. Read Article →
- Pirtobrutinib (Jaypirca): From Non-Covalent BTK Inhibition to Expanded CLL Pharmacovigilance Pirtobrutinib is a selective, reversible, non-covalent BTK inhibitor developed to retain BTK inhibition when covalent inhibitors lose activity through resistance or intolerance. Its regulatory history now spans mantle cell lymphoma and several CLL/SLL populations, making changing exposure and indication boundaries central to pharmacovigilance. Read Article →
- Pertuzumab–Trastuzumab–Hyaluronidase Fixed-Dose Subcutaneous Combination: Safety and Pharmacovigilance The fixed-dose subcutaneous pertuzumab–trastuzumab combination uses recombinant human hyaluronidase to permit delivery of two HER2-directed antibodies in a large subcutaneous volume. Its active-antibody biology is shared with pertuzumab and trastuzumab, but fixed dosing, distinct loading and maintenance presentations, subcutaneous delivery and product-specific administration create independent pharmacovigilance questions. Read Article →
- Pertuzumab: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Pertuzumab is a humanised IgG1 monoclonal antibody directed against subdomain II of HER2. By interfering with ligand-dependent HER2 heterodimerisation, it complements rather than duplicates trastuzumab. This article explains its molecular design, HER2 biology, development and clinical use, then connects its mechanism and treatment context to cardiac surveillance, embryo-fetal toxicity, infusion and hypersensitivity reactions, diarrhoea, neutropenia, ICSR assessment, signal detection and longitudinal pharmacovigilance. Read Article →
- Pegloticase: Uricase Biology, Refractory Gout, Immunogenicity and Product Pharmacovigilance Pegloticase replaces an enzymatic function humans lost during evolution: uricase-mediated conversion of uric acid to allantoin. This article explains how that mechanism can rapidly debulk urate, why anti-drug antibodies can cause abrupt loss of response and infusion risk, and how modern methotrexate co-therapy changes both efficacy and pharmacovigilance. Read Article →
- Pembrolizumab: Classification, History, Mechanism of Action, Immune Toxicity and Pharmacovigilance Pembrolizumab is a humanised, Fc-stabilised IgG4 kappa monoclonal antibody that blocks PD-1 interaction with PD-L1 and PD-L2. By releasing inhibitory signalling in antigen-experienced lymphocytes it can restore antitumour immunity across biomarker- and tumour-defined settings, while producing delayed, multisystem immune-mediated toxicity. This article integrates molecular pharmacology, clinical and regulatory history, biomarkers, resistance, organ-specific safety and longitudinal pharmacovigilance. Read Article →
- Pegfilgrastim: Pegylated G-CSF, Neutrophil Recovery and Pharmacovigilance Pegfilgrastim is a long-acting pegylated granulocyte colony-stimulating factor used to reduce chemotherapy-induced neutropenia and febrile neutropenia. This article connects its molecular design and neutrophil-mediated clearance to dosing, bone pain, leukocytosis, splenic and pulmonary events, aortitis, device errors, biosimilar traceability and longitudinal case assessment. Read Article →
- Panitumumab: EGFR Biology, RAS Selection, Colorectal Cancer and Product Pharmacovigilance Panitumumab is a fully human anti-EGFR monoclonal antibody whose clinical value depends on tumour signalling context. This article explains EGFR–RAS biology, why RAS testing is central to treatment selection, the modern KRAS G12C exception with sotorasib, and how mechanism shapes dermatologic, electrolyte, pulmonary and ocular pharmacovigilance. Read Article →
- Palivizumab: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Palivizumab is a humanised monoclonal antibody that binds antigenic site II of the RSV fusion protein and provides passive seasonal protection to selected high-risk infants and young children. This article explains how monthly exposure, breakthrough RSV disease, viral resistance and paediatric administration factors shape pharmacovigilance. Read Article →
- Ofatumumab: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Ofatumumab is a fully human anti-CD20 monoclonal antibody. Its history is unusual because the same molecule moved from high-dose intravenous oncology use into lower-dose subcutaneous treatment of relapsing multiple sclerosis. This article explains CD20 biology, B-cell depletion and why route, dose, indication and prior immune therapy must be preserved when assessing infection, hepatitis B reactivation, PML, hypogammaglobulinaemia, pregnancy and injection-related reactions. Read Article →
- Omalizumab: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Omalizumab is a humanised IgG1 monoclonal antibody that binds free immunoglobulin E and prevents its interaction with high-affinity IgE receptors. By lowering free IgE, it also down-regulates Fc epsilon RI expression on basophils, mast cells and other cells. This article explains the IgE system, omalizumab development and indication-specific use, then connects its mechanism to anaphylaxis risk, allergic-disease confounding, serum-sickness-like reactions, eosinophilic conditions, self-administration, dosing errors, biosimilar traceability and pharmacovigilance practice. Read Article →
- Ocrelizumab: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Ocrelizumab is a humanised IgG1 anti-CD20 monoclonal antibody used in relapsing and primary progressive multiple sclerosis. By depleting CD20-positive B cells while sparing stem cells and most plasma cells, it alters antigen presentation, cytokine networks and the B-cell contribution to CNS autoimmunity. This article explains disease biology, anti-CD20 pharmacology and route-specific treatment, then connects those concepts to infusion or injection reactions, serious infection, hepatitis B reactivation, progressive multifocal leukoencephalopathy, immunoglobulin decline, vaccination, pregnancy and infant B-cell considerations, malignancy surveillance and longitudinal pharmacovigilance. Read Article →
- Ocrelizumab and Hyaluronidase Subcutaneous Formulation: Safety and Pharmacovigilance Explains what changes when ocrelizumab is delivered subcutaneously with recombinant hyaluronidase and how to separate formulation-specific risks from the parent anti-CD20 safety profile. Read Article →
- Obinutuzumab: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Obinutuzumab is a glycoengineered, humanised type II anti-CD20 IgG1 monoclonal antibody. Its reduced-fucose Fc increases affinity for Fc gamma RIII receptors, while type II CD20 engagement favours direct cell-death and cellular effector mechanisms relative to classical type I anti-CD20 biology. This article explains how those properties translate into clinical use and into pharmacovigilance priorities including infusion-related reactions, tumour lysis syndrome, serious infection, hepatitis B reactivation, progressive multifocal leukoencephalopathy, cytopenias, treatment-context attribution and biological traceability. Read Article →
- Nivolumab: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Nivolumab is a fully human IgG4 monoclonal antibody that binds programmed cell death protein 1 (PD-1) and prevents interaction with PD-L1 and PD-L2. The resulting pharmacological effect is immune reactivation rather than direct tumour-cell killing. This article explains how that mechanism, the wide range of cancer indications and frequent combination regimens shape case assessment, signal detection, risk management and periodic benefit-risk evaluation. Read Article →
- Nipocalimab: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Nipocalimab is a fully human monoclonal antibody that blocks the neonatal Fc receptor (FcRn), accelerating IgG degradation and thereby reducing pathogenic IgG autoantibodies. This article explains FcRn physiology, the mechanistic differences between generalised myasthenia gravis and warm autoimmune haemolytic anaemia, the evolving regional indication landscape, and the pharmacovigilance implications of sustained IgG lowering. Read Article →
- Nirsevimab: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Nirsevimab is an extended-half-life human IgG1 kappa monoclonal antibody that binds the prefusion form of the RSV fusion protein and prevents viral entry. It provides passive immunity rather than vaccination, and its pharmacovigilance requires careful interpretation of age, weight, RSV season, dose, breakthrough infection, hypersensitivity and evolving post-marketing signals. Read Article →
- Nemolizumab: Mechanism, Clinical Safety and Pharmacovigilance Nemolizumab is a humanised IgG2 antibody that blocks IL-31 receptor alpha. Its EU indications include moderate-to-severe atopic dermatitis from age 12 and adult prurigo nodularis. This article links indication-specific dosing with hypersensitivity, injection-site reactions, asthma worsening and traceable pharmacovigilance. Read Article →
- Natalizumab: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Natalizumab is a humanised IgG4 monoclonal antibody that blocks α4-integrin-mediated leukocyte adhesion and trafficking. Its pharmacovigilance requires structured assessment of JCV status, prior immunosuppression, treatment duration, neurological symptoms, disease rebound and product traceability. Read Article →
- Muromonab-CD3: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Muromonab-CD3 was a murine IgG2a monoclonal antibody directed against the CD3 complex on human T lymphocytes and became the first monoclonal antibody approved for therapeutic use. Its history is unusually instructive for pharmacovigilance because the same CD3 engagement that produced potent immunosuppression could trigger marked first-dose cytokine release, while repeated exposure introduced immunogenicity, infection and cumulative-immunosuppression concerns. Read Article →
- Mosunetuzumab: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Mosunetuzumab is a CD20Ă—CD3 bispecific monoclonal antibody that redirects T cells toward CD20-positive B cells. This article explains its molecular and functional classification, follicular-lymphoma context, step-up dosing and fixed-duration treatment, then connects its mechanism to cytokine release syndrome, neurologic toxicity, tumour flare, infection, cytopenias, tumour lysis and pharmacovigilance case assessment. Read Article →
- Mosunetuzumab Subcutaneous Formulation: Dosing, Safety and Pharmacovigilance Explains how the subcutaneous mosunetuzumab formulation changes administration kinetics, dosing, cytokine-release behaviour and medication-error controls while retaining CD20xCD3 T-cell-engager biology. Read Article →
- Moxetumomab Pasudotox: Classification, History, Mechanism, Safety and Pharmacovigilance Moxetumomab pasudotox is an antibody-derived recombinant immunotoxin rather than a conventional monoclonal antibody. A CD22-binding antibody variable fragment delivers a truncated Pseudomonas exotoxin into malignant B cells. This article explains the two-part mechanism, its distinctive capillary-leak and haemolytic-uraemic safety profile, and the pharmacovigilance lessons from a now-discontinued biological. Read Article →
- Monoclonal Antibodies: Scientific Classification and Pharmacovigilance Landscape Understand the therapeutic monoclonal-antibody landscape through a multidimensional classification framework and locate major antibody classes, formats and mechanisms within it. Read Article →
- Monoclonal Antibodies: Classification and Pharmacovigilance Understand how therapeutic monoclonal antibodies are structured and classified, how their mechanisms and development characteristics influence safety, and how these properties shape pharmacovigilance across the product lifecycle. Read Article →
- Monoclonal Antibodies: Classification by Mechanism of Action and Pharmacovigilance Understand the principal mechanisms by which therapeutic monoclonal antibodies produce biological effects and how those mechanisms provide a framework for pharmacovigilance. Read Article →
- Monoclonal Antibodies: Biology, Development and Pharmacovigilance Understand how therapeutic monoclonal antibodies work as biological medicines and how their molecular design, target biology, development and clinical use determine their pharmacovigilance characteristics. Read Article →
- Mogamulizumab: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Mogamulizumab is a defucosylated humanised IgG1 kappa monoclonal antibody directed against C-C chemokine receptor type 4 (CCR4). This article connects its molecular mechanism and clinical context with event follow-up, causality assessment, signal detection, risk management and product traceability. Read Article →
- Mirikizumab: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Mirikizumab is a humanised IgG4 monoclonal antibody directed against IL-23 p19 subunit. Its effect is binding the p19 subunit of IL-23 and interrupting IL-23-mediated inflammatory signalling. This article explains how those features shape case assessment, signal detection, risk management and periodic benefit-risk evaluation. Read Article →
- Meningococcal Group C Tetanus-Toxoid Conjugate Vaccine: Immunology and Pharmacovigilance Meningococcal group C tetanus-toxoid conjugate vaccine converts a capsular polysaccharide antigen into a T-cell-dependent immunogen. Its pharmacovigilance depends on age and schedule context, exact product and lot, co-administered vaccines, and microbiological confirmation of suspected breakthrough meningococcal disease. Read Article →
- Meningococcal Groups A, B, C, W and Y Vaccine: Combined Antigen Design and Pharmacovigilance Pentavalent meningococcal vaccination combines two vaccine technologies in one product: conjugated capsular polysaccharides for groups A, C, W and Y and recombinant fHbp antigens for group B. Pharmacovigilance must therefore preserve component, schedule and jurisdiction context while evaluating adverse events and invasive disease after vaccination. Read Article →
- Meningococcal Groups A, C, W and Y Tetanus-Toxoid Conjugate Vaccine: Immunology and Pharmacovigilance MenACWY tetanus-toxoid conjugate vaccine contains capsular polysaccharides from meningococcal groups A, C, W and Y, each conjugated to tetanus toxoid. Pharmacovigilance requires exact vaccine and schedule reconstruction, age-specific interpretation, co-administration context and serogroup-specific investigation of breakthrough invasive disease. Read Article →
- Mepolizumab: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Mepolizumab is a humanised IgG1 monoclonal antibody directed against interleukin-5 (IL-5). Its effect is binding IL-5 and reducing eosinophil growth, maturation, recruitment and survival signals. This article explains how those features shape case assessment, signal detection, risk management and periodic benefit-risk evaluation. Read Article →
- Meningococcal Group B Vaccine (Recombinant): fHbp Biology, Immunisation and Pharmacovigilance The recombinant meningococcal group B vaccine uses lipidated fHbp antigens from two subfamilies to induce bactericidal antibodies against serogroup B meningococci. Pharmacovigilance must preserve age, dose schedule, co-administered vaccines, lot and event chronology, while suspected breakthrough disease requires microbiological confirmation and strain-level antigen context where available. Read Article →
- Marstacimab: Classification, Mechanism, Haemophilia Use and Pharmacovigilance Marstacimab improves haemostatic potential by inhibiting tissue factor pathway inhibitor rather than replacing factor VIII or IX. This rebalancing mechanism changes both treatment logic and pharmacovigilance: safety assessment must follow bleeding control, thrombotic risk, concomitant haemostatic therapy and inhibitor status together. Read Article →
- Loncastuximab tesirine: Mechanism, Clinical Safety and Pharmacovigilance Loncastuximab tesirine combines a CD19 antibody with the DNA-crosslinking payload SG3199 for adults with relapsed or refractory large B-cell lymphoma after multiple prior therapies. This article links conditional EU authorisation and cycle-dependent dosing with cytopenias, liver-enzyme elevations, oedema, effusions and photosensitivity. Read Article →
- Linvoseltamab: BCMA-Directed T-Cell Engagement and Pharmacovigilance Linvoseltamab is a bispecific monoclonal antibody that binds BCMA on multiple myeloma cells and CD3 on T cells, bringing the cells together to drive tumour-cell killing. Its pharmacovigilance depends on treatment phase, step-up dosing, cytokine release syndrome, neurotoxicity, infection risk and conditional-authorisation evidence. Read Article →
- Lirafugratinib (Lyrfigtu): FGFR2-Targeted Cholangiocarcinoma Development and Pharmacovigilance Lirafugratinib is a covalent, highly selective FGFR2 inhibitor approved by FDA in September 2026 for previously treated unresectable, locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or other rearrangement. Its development illustrates precision oncology, resistance-mutation targeting and an attempt to reduce pan-FGFR toxicity, while its current label requires substantial ocular and phosphate monitoring. Read Article →
- Lebrikizumab: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Lebrikizumab is a humanised IgG4 monoclonal antibody directed against IL-13. Its effect is binding IL-13 and reducing signalling through the IL-4 receptor alpha/IL-13 receptor alpha 1 complex. This article explains how those features shape case assessment, signal detection, risk management and periodic benefit-risk evaluation. Read Article →
- Lecanemab: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Lecanemab is a humanised IgG1 monoclonal antibody directed against aggregated amyloid-beta protofibrils. This article explains how its target, route and clinical context shape case assessment, signal detection, risk management and periodic benefit-risk evaluation. Read Article →
- Ligand-Neutralising Monoclonal Antibodies: Mechanism, Clinical Use and Pharmacovigilance Understand how ligand-neutralising monoclonal antibodies modify soluble signalling pathways, why their safety profiles depend on ligand biology and exposure, and how mechanism informs pharmacovigilance without replacing product-specific evidence. Read Article →
- Ixekizumab: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Ixekizumab is a humanised IgG4 monoclonal antibody directed against IL-17A. Its effect is binding IL-17A and preventing activation of the IL-17 receptor pathway. This article explains how those features shape case assessment, signal detection, risk management and periodic benefit-risk evaluation. Read Article →
- Lanadelumab: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Lanadelumab is a human monoclonal antibody that inhibits plasma kallikrein and reduces bradykinin generation. This article explains how long-interval subcutaneous prevention, breakthrough attacks and product traceability shape pharmacovigilance. Read Article →
- Isatuximab: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Isatuximab is a chimeric IgG1 monoclonal antibody directed against CD38. In multiple myeloma it is used in combination regimens, so pharmacovigilance must separate direct pharmacology from disease-related marrow failure, combination-treatment effects and CD38-related interference with pre-transfusion testing. Read Article →
- Ipilimumab: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Ipilimumab is a fully human IgG1 monoclonal antibody that blocks cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), an inhibitory regulator of T-cell activation. Its pharmacology differs from PD-1 blockade because it acts principally during early T-cell priming and can produce broad immune-mediated toxicity, especially in combination regimens. This article explains the mechanism, clinical context and pharmacovigilance implications. Read Article →
- Interferon Gamma-1b: Immune Signalling, CGD, Osteopetrosis and Product Pharmacovigilance Interferon gamma-1b is recombinant human interferon-Îł used in the United States to reduce serious infections in chronic granulomatous disease and delay progression of severe malignant osteopetrosis. This article explains IFN-Îł biology, disease mechanisms, the limits of mechanistic certainty, and the practical safety profile of long-term cytokine therapy. Read Article →
- Insulin Glargine: History, Classification, Mechanism of Action, Safety and Pharmacovigilance Insulin glargine is a recombinant long-acting human insulin analogue whose amino-acid substitutions alter solubility and create prolonged subcutaneous delivery while retaining insulin-receptor agonism. This article separates molecular pharmacology from formulation-dependent absorption and translates its product family, safety profile and error risks into practical pharmacovigilance. Read Article →
- Inebilizumab: CD19 B-Cell Depletion Across NMOSD, IgG4-RD and gMG Inebilizumab is a CD19-directed cytolytic monoclonal antibody that depletes a broader B-cell compartment than CD20-directed therapies. This article explains how that biology supports use across antibody-mediated diseases and how infection, immunoglobulin reduction, infusion reactions and disease-specific confounding shape pharmacovigilance. Read Article →
- Infliximab: History, Classification, Mechanism of Action, Safety and Pharmacovigilance Infliximab is a chimeric human–murine IgG1 monoclonal antibody that binds soluble and transmembrane TNF. Its molecular format, intermittent intravenous exposure and immunogenicity shape efficacy, infusion reactions and long-term safety surveillance. Read Article →
- Inotuzumab Ozogamicin: Classification, Mechanism, ALL Use and Pharmacovigilance Inotuzumab ozogamicin combines CD22-directed delivery with a calicheamicin cytotoxic payload. Its pharmacovigilance requires simultaneous understanding of target biology, cumulative ADC exposure, marrow toxicity, hepatic sinusoidal injury and the altered risk created by subsequent haematopoietic stem-cell transplantation. Read Article →
- Immune-Checkpoint Monoclonal Antibodies: T-Cell Reinvigoration, Immune-Related Toxicity and Pharmacovigilance Understand how immune-checkpoint antibodies alter physiological immune brakes, why their safety profile differs from direct cytotoxic antibodies, and how pharmacovigilance should connect immune activation with clinical events. Read Article →
- ICSR Management for Biological Medicinal Products This article explains how biological-product identity, batch traceability, manufacturing history, immunogenicity, formulation, device, switching and product-quality information alter every stage of ICSR management. A continuing monoclonal-antibody example connects intake, validity, follow-up, coding, causality, narrative, duplicate management and ICH E2B(R3) transmission. Read Article →
- Iberdomide (Zenbexus): CELMoD Development, Accelerated Approval and Pharmacovigilance Iberdomide is the first FDA-approved cereblon E3 ligase modulator (CELMoD), approved in August 2026 with daratumumab and hyaluronidase-fihj plus dexamethasone for adults with multiple myeloma after at least one prior line including a proteasome inhibitor and an immunomodulatory agent. Read Article →
- How to Write a PBRER or PSUR for a Biological Medicinal Product This technical textbook guide explains the title page, executive summary and every formal PBRER section and subsection. It shows how biological identity, brand, batch, manufacturing change, immunogenicity, formulation, device, route, biosimilar switching and class effects alter data selection, analysis, risk characterisation, benefit evaluation and regulatory action through a continuing monoclonal-antibody example. Read Article →
- Human Normal Immunoglobulin (IVIG): Classification, Mechanism, Safety and Pharmacovigilance IVIG is a pooled plasma-derived IgG biological used both to replace missing antibody function and to modulate immune disease. Its pharmacovigilance depends on product and batch identity, infusion conditions, dose and indication, patient thrombotic and renal risk, haemolysis, neurological and pulmonary syndromes, and the manufacturing controls inherent to a plasma-derived medicine. Read Article →
- How to Develop and Maintain Risk Management Plans for Biological Medicinal Products This article explains how to construct and maintain an EU risk management plan for a biological medicine. It connects product overview, epidemiology, non-clinical and clinical evidence, missing populations, post-authorisation experience, identified and potential risks, pharmacovigilance, efficacy studies, risk minimisation, public summaries and annexes, with worked biological examples and international format comparisons. Read Article →
- Guselkumab: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Guselkumab is a human monoclonal antibody that selectively binds the p19 subunit of interleukin-23. This article explains how p19 blockade differs from p40 blockade, how one cytokine pathway connects skin, joint and intestinal inflammation, and how indication, dosing regimen, infection risk, hypersensitivity, liver-test abnormalities and product traceability shape pharmacovigilance. Read Article →
- Glofitamab: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Glofitamab is a CD20Ă—CD3 bispecific T-cell-engaging antibody with bivalent CD20 binding and monovalent CD3 binding. This article explains how its 2:1 architecture redirects T cells toward malignant B cells, why obinutuzumab pre-treatment and step-up dosing modify early immune activation, and how pharmacovigilance should evaluate CRS, neurologic toxicity, tumour flare, infection, cytopenias, tumour lysis, combination-treatment effects and product traceability. Read Article →
- Golimumab: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Golimumab is a fully human IgG1 kappa monoclonal antibody that binds tumour necrosis factor alpha in soluble and membrane-associated forms. This article explains how TNF neutralisation links its rheumatology and gastroenterology indications, why indication and route influence exposure and safety interpretation, and how anti-TNF class risks should be assessed at product level. Read Article →
- Gemtuzumab Ozogamicin: Classification, Mechanism, AML Use and Pharmacovigilance Gemtuzumab ozogamicin targets CD33-positive myeloid cells and delivers a calicheamicin cytotoxic payload. Its safety profile is shaped by the interaction between ADC exposure, AML-related marrow failure, combination chemotherapy and hepatic sinusoidal injury. Read Article →
- Gefurulimab (Klygefa): Dual-Binding C5 Nanobody Development and Pharmacovigilance in Generalised Myasthenia Gravis Gefurulimab is a humanised dual-binding VHH antibody that blocks complement C5 while binding serum albumin to extend exposure, enabling once-weekly subcutaneous treatment. Its development for AChR-antibody-positive generalised myasthenia gravis creates pharmacovigilance questions around terminal-complement inhibition, serious infection, immunogenicity, self-administration, device performance and long-term evidence. Read Article →
- Garadacimab: FXIIa Inhibition, Hereditary Angioedema and Pharmacovigilance Garadacimab is a monoclonal antibody that inhibits activated factor XII (FXIIa), reducing bradykinin generation in hereditary angioedema. Its preventive use, monthly dosing and limits in hereditary angioedema with normal C1-inhibitor require exposure-aware case assessment and careful interpretation of breakthrough attacks. Read Article →
- Galcanezumab: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Galcanezumab is a humanised IgG4 monoclonal antibody directed against calcitonin gene-related peptide (CGRP). Its effect is binding CGRP and reducing its ability to activate CGRP receptors involved in migraine biology. This article explains how those features shape case assessment, signal detection, risk management and periodic benefit-risk evaluation. Read Article →
- Fremanezumab: Mechanism, Clinical Safety and Pharmacovigilance Fremanezumab is a monoclonal antibody that binds calcitonin gene-related peptide (CGRP) to prevent migraine. This article explains how dose schedule, migraine variability, delayed hypersensitivity and limits in clinical-trial populations affect case assessment and aggregate safety review. Read Article →
- Fidanacogene Elaparvovec: AAV Gene Therapy for Haemophilia B and Pharmacovigilance Fidanacogene elaparvovec is a one-time AAV-based gene therapy designed to deliver a high-activity factor IX transgene to hepatocytes. Its pharmacovigilance is dominated by eligibility, liver-directed immune responses, longitudinal factor IX expression, bleeding and thrombotic outcomes, durability and traceability across a treatment that cannot simply be discontinued after administration. Read Article →
- Filgrastim: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Filgrastim is a short-acting, non-glycosylated recombinant human granulocyte colony-stimulating factor produced in Escherichia coli. By activating the G-CSF receptor on neutrophil precursors and mature neutrophils, it accelerates neutrophil production and function and mobilises haematopoietic progenitor cells. Its safety profile spans predictable bone pain and leukocytosis, rare acute syndromes such as splenic rupture, ARDS, capillary leak and aortitis, and indication-specific questions including clonal evolution in severe congenital neutropenia and long-term follow-up of healthy donors. Read Article →
- The Evolution of Biological Medicines: From Blood Products to Advanced Therapies Trace the major technological and regulatory transitions that shaped biological medicines, and understand how each transition introduced new product characteristics, safety questions and pharmacovigilance requirements. Read Article →
- Faricimab: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Faricimab is a bispecific intravitreal antibody directed against VEGF-A and angiopoietin-2. This article explains why those two vascular pathways are linked, how dual inhibition differs from conventional anti-VEGF monotherapy, and how the mechanism, intravitreal route and retinal disease context shape pharmacovigilance for intraocular inflammation, retinal vasculitis, endophthalmitis, intraocular pressure changes, retinal tears or detachment, systemic vascular events and treatment-response assessment. Read Article →
- Evinacumab: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Evinacumab is a fully human IgG4 monoclonal antibody that inhibits angiopoietin-like protein 3. This article explains its LDL-receptor-independent mechanism, combination-treatment context, infusion safety and cardiovascular pharmacovigilance. Read Article →
- Evolocumab: PCSK9 Biology, LDL-Receptor Recycling, Cardiovascular Benefit and Product Pharmacovigilance Evolocumab is a fully human IgG2 monoclonal antibody that neutralises PCSK9. By preventing PCSK9-mediated lysosomal degradation of hepatic LDL receptors, it increases receptor recycling and removal of LDL cholesterol from plasma. Its use and benefit–risk differ across primary hypercholesterolaemia, familial hypercholesterolaemia and established atherosclerotic cardiovascular disease. Read Article →
- Etanercept: TNF-Receptor Biology, Fusion-Protein Mechanism, Indication Mapping, Safety and Product Pharmacovigilance Etanercept is a recombinant dimeric fusion protein composed of the extracellular ligand-binding region of human TNF receptor 2 joined to the Fc region of human IgG1. It acts primarily as a soluble decoy receptor for TNF and also binds lymphotoxin-alpha. Its clinical effects and risks follow from suppressing TNF-dependent inflammatory communication, but its structure and functional behaviour differ from monoclonal anti-TNF antibodies—helping explain why products grouped as TNF inhibitors do not share every indication or clinical effect. Read Article →
- Eptinezumab: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Eptinezumab is a humanised IgG1 monoclonal antibody that binds calcitonin gene-related peptide. This article explains how intravenous preventive treatment, migraine biology, hypersensitivity and cardiovascular context shape pharmacovigilance. Read Article →
- Erenumab: CGRP-Receptor Biology, Migraine Prevention and Product Pharmacovigilance Erenumab is a monoclonal antibody that blocks the canonical CGRP receptor rather than the CGRP ligand. This article explains migraine neurovascular biology, how receptor blockade prevents attacks, and why gastrointestinal and vascular postmarketing risks are central to product pharmacovigilance. Read Article →
- Epoetin Alfa: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Epoetin alfa is a recombinant human erythropoietin and erythropoiesis-stimulating agent produced in CHO cells. It activates the erythropoietin receptor on erythroid progenitors to prevent apoptosis and promote red-cell production, but response depends on iron availability and the cause of anaemia. This article integrates its biological classification, development history, mechanism, clinical use, haemoglobin-guided safety, cardiovascular and thrombotic risk, tumour concerns, immunogenic pure red-cell aplasia and product/device pharmacovigilance. Read Article →
- Enzyme Replacement Therapies: Classification and Pharmacovigilance Understand how enzyme replacement therapies restore or supplement deficient enzyme activity, how their molecular and delivery characteristics shape safety, and how these characteristics inform pharmacovigilance. Read Article →
- Epcoritamab: Mechanism, Clinical Safety and Pharmacovigilance Epcoritamab is a subcutaneous bispecific antibody that brings CD3-positive T cells into contact with CD20-positive B cells. This article explains how that mechanism informs the assessment of immune activation, B-cell depletion, overlapping oncology treatments and product-specific pharmacovigilance. Read Article →
- Ensartinib (Gevalka): ALK Inhibition, Clinical Development and Pharmacovigilance in ALK-Positive NSCLC Ensartinib is an oral ALK tyrosine-kinase inhibitor for ALK-positive advanced non-small cell lung cancer. Its development illustrates how efficacy against systemic and intracranial disease must be integrated with surveillance for dermatologic toxicity, hepatotoxicity, pneumonitis, metabolic and cardiac effects, and the consequences of treatment sequencing. Read Article →
- Emicizumab: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Emicizumab is a humanised bispecific monoclonal antibody that functionally substitutes for part of activated factor VIII cofactor activity by bringing activated factor IX and factor X into productive proximity. This article explains its molecular design, haemophilia A context, clinical use and distinctive pharmacovigilance challenges, including bypassing-agent interactions, thrombosis, thrombotic microangiopathy, assay interference, breakthrough bleeding, anti-drug antibodies and medication-error assessment. Read Article →
- Elranatamab: Classification, Mechanism, Clinical Use and Pharmacovigilance Elranatamab redirects T cells toward BCMA-expressing plasma cells. Its benefit-risk profile therefore depends not only on tumour response but on the controlled initiation of immune-cell engagement, recognition of CRS and neurotoxicity, and management of prolonged infection and marrow-suppression risks. Read Article →
- Elotuzumab: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Elotuzumab is a humanised IgG1 monoclonal antibody directed against SLAMF7, a surface protein expressed on plasma cells and natural killer cells. It does not operate as an isolated cytotoxic treatment: its clinical activity depends on immune effector cells and combination with immunomodulatory medicines and dexamethasone. This article explains the mechanism, multiple-myeloma treatment context and pharmacovigilance priorities. Read Article →
- Durvalumab: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Durvalumab is a human IgG1 monoclonal antibody that blocks PD-L1 interactions with PD-1 and CD80, restoring antitumour T-cell activity. Its pharmacovigilance requires separation of immune-mediated toxicity from chemotherapy, radiotherapy, surgery and underlying cancer, while also accounting for substantial indication and regimen expansion across the product lifecycle. Read Article →
- Eculizumab Biosimilar: C5 Complement Blockade, Biosimilarity and Pharmacovigilance Eculizumab biosimilar products reproduce the clinically relevant attributes of reference eculizumab, a C5-blocking monoclonal antibody. This article explains terminal-complement blockade, disease-specific benefit and risk, EU biosimilarity, US interchangeability, infection risk minimisation, sorbitol-related restrictions, traceability, switching and longitudinal safety assessment. Read Article →
- Eculizumab: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Eculizumab is a humanised monoclonal antibody that blocks complement component C5. This article explains how one terminal-complement mechanism produces different therapeutic effects in PNH, aHUS, generalised myasthenia gravis and NMOSD, why meningococcal susceptibility is inseparable from the mechanism, and how indication-specific evidence changes pharmacovigilance assessment. Read Article →
- Dupilumab: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Dupilumab is a fully human IgG4 monoclonal antibody that binds interleukin-4 receptor alpha (IL-4Rα), thereby inhibiting IL-4 and IL-13 signalling. It is used across type 2 inflammatory diseases with distinct tissue biology: atopic dermatitis, asthma, chronic obstructive pulmonary disease with type 2 inflammation, chronic rhinosinusitis with nasal polyps, prurigo nodularis, eosinophilic oesophagitis and chronic spontaneous urticaria in defined settings. Its benefit–risk profile is driven by indication: ocular surface disease is particularly relevant in atopic dermatitis, while eosinophilic syndromes and corticosteroid reduction require careful assessment in airway disease. Read Article →
- Dostarlimab: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Dostarlimab is a humanised IgG4 monoclonal antibody directed against PD-1. Its effect is blocking PD-1 interaction with PD-L1 and PD-L2 and releasing inhibitory T-cell signalling. This article explains how those features shape case assessment, signal detection, risk management and periodic benefit-risk evaluation. Read Article →
- Donanemab: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Donanemab is a humanised IgG1 monoclonal antibody directed against deposited amyloid beta. Its effect is binding a modified amyloid-beta epitope in plaques and promoting plaque clearance. This article explains how those features shape case assessment, signal detection, risk management and periodic benefit-risk evaluation. Read Article →
- Dinutuximab Beta: Mechanism, Clinical Safety and Pharmacovigilance Dinutuximab beta is an anti-GD2 monoclonal antibody used in defined high-risk or relapsed/refractory neuroblastoma settings. This article links its tumour target with predictable neuropathic pain, cytokine-release and infusion reactions, and the exposure details needed for meaningful safety assessment. Read Article →
- Depemokimab: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Depemokimab is a humanised IgG1 monoclonal antibody directed against interleukin-5 (IL-5). Its effect is binding IL-5 and suppressing eosinophil-mediated type 2 inflammation over an extended dosing interval. This article explains how those features shape case assessment, signal detection, risk management and periodic benefit-risk evaluation. Read Article →
- Denosumab: From RANKL Biology to Indication-Specific Benefit, Safety and Product Pharmacovigilance Denosumab is a fully human IgG2 monoclonal antibody that neutralises RANK ligand (RANKL), a key signal required for osteoclast formation and bone resorption. Its benefit and risk depend strongly on clinical context: the same mechanism can prevent fragility fractures, reduce cancer-related skeletal events or alter the course of giant-cell tumour of bone, while creating predictable risks such as hypocalcaemia, osteonecrosis of the jaw, atypical femoral fracture and rebound vertebral fractures after missed or stopped treatment. Read Article →
- Denecimig (Frehemgo): From Bispecific FVIII Mimic to Next-Generation Haemophilia A Pharmacovigilance Denecimig is a fully human modified IgG4 bispecific antibody that mimics activated factor VIII by bridging FIXa and FX. Its development across patients with and without FVIII inhibitors, multiple dosing intervals and different age groups creates distinctive pharmacovigilance questions around coagulation balance, immunogenicity, treatment switching and long-term exposure. Read Article →
- Delandistrogene Moxeparvovec: Micro-Dystrophin Gene Therapy and Pharmacovigilance Delandistrogene moxeparvovec is a one-time AAVrh74 gene therapy that delivers a micro-dystrophin transgene to muscle in ambulatory patients with Duchenne muscular dystrophy. Its history links uncertain surrogate evidence and a missed phase 3 primary endpoint with rapid regulatory expansion, fatal post-authorisation liver injury, an FDA boxed warning and an ambulatory-only US indication. Read Article →
- Darbepoetin Alfa: Erythropoietin Biology, Anaemia Treatment and Product Pharmacovigilance Darbepoetin alfa is a hyperglycosylated erythropoiesis-stimulating protein engineered for prolonged activity. This article connects erythropoietin physiology and glycoengineering to clinical use, benefit-risk boundaries and product-level pharmacovigilance. Read Article →
- Datopotamab Deruxtecan: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Datopotamab deruxtecan is a TROP2-directed antibody-drug conjugate that delivers a deruxtecan topoisomerase-I inhibitor payload through a cleavable linker. This article explains its ADC mechanism and why pharmacovigilance requires targeted surveillance for stomatitis, ocular toxicity and ILD/pneumonitis in addition to conventional cytotoxic adverse effects. Read Article →
- Daratumumab: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Daratumumab is a human IgG1 kappa monoclonal antibody directed against CD38. This article explains how CD38 expression on plasma cells links the mechanism of action to efficacy and safety, why infusion or injection reactions and infection risks require clinical context, and why two laboratory interferences—pre-transfusion antibody testing and myeloma response assays—are central pharmacovigilance and medication-safety issues. Read Article →
- Crizanlizumab: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Crizanlizumab is a humanised IgG2 kappa monoclonal antibody that blocks P-selectin and thereby reduces selectin-mediated cellular adhesion involved in sickle-cell vaso-occlusion. Its regulatory history is unusually instructive: early efficacy evidence supported approval, but a later confirmatory trial failed to reproduce the expected benefit, leading to EU revocation while U.S. authorisation remained active. Read Article →
- Crovalimab: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Crovalimab is a humanised anti-C5 monoclonal antibody engineered for pH-dependent target release and antibody recycling. By preventing cleavage of complement C5, it suppresses terminal-complement-mediated intravascular haemolysis in paroxysmal nocturnal haemoglobinuria. This article explains PNH and complement biology, recycling-antibody pharmacology and clinical use, then connects those concepts to meningococcal and other encapsulated-bacterial infection risk, breakthrough haemolysis, switching reactions, immune complexes, dosing and administration errors, pregnancy considerations and long-term pharmacovigilance. Read Article →
- COVID-19 mRNA Vaccines: Platform Biology, Variant Adaptation, Safety and Pharmacovigilance SARS-CoV-2 mRNA vaccines combine a rapidly adaptable nucleic-acid antigen sequence with lipid-nanoparticle delivery. Their pharmacovigilance therefore requires precise identification of formulation, strain version, age presentation and dose alongside surveillance for recognised adverse events and vaccination errors. Read Article →
- Concizumab: Mechanism, Clinical Safety and Pharmacovigilance Concizumab is an anti-TFPI monoclonal antibody used as haemophilia prophylaxis. This article explains how its rebalancing approach differs from factor replacement, why breakthrough-bleed treatment is central to safety interpretation, and how pharmacovigilance should reconstruct both haemostatic exposures. Read Article →
- Coagulation Factor Products: Classification and Pharmacovigilance Understand how coagulation factor products are classified, how replacement of haemostatic proteins influences efficacy and safety, and how inhibitors, thrombosis, hypersensitivity, traceability and product-specific characteristics shape pharmacovigilance. Read Article →
- Certolizumab Pegol: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Certolizumab pegol is a PEGylated, Fc-free Fab′ fragment derived from a humanised anti-TNF monoclonal antibody. Its structure affects distribution, placental transfer and immune-effector biology, so pharmacovigilance must distinguish it from full-length anti-TNF antibodies and from non-antibody TNF inhibitors. Read Article →
- Cetuximab: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Cetuximab is a chimeric IgG1 monoclonal antibody directed against epidermal growth factor receptor (EGFR). This article connects its molecular mechanism and clinical context with event follow-up, causality assessment, signal detection, risk management and product traceability. Read Article →
- Cenobamate (Ontozry/Xcopri): From Drug Discovery to Severe Liver Injury and Evolving Pharmacovigilance Cenobamate is an antiseizure medicine developed for drug-resistant focal epilepsy. Its lifecycle illustrates how a highly effective therapy can acquire new post-authorisation safety controls: European pharmacovigilance review in 2026 identified liver injury as a rare adverse reaction and led to strengthened liver monitoring after reports of severe liver injury and hepatic failure. Read Article →
- Cell-Directed Monoclonal Antibodies: Cell Depletion, Fc-Mediated Mechanisms and Pharmacovigilance Understand how cell-directed monoclonal antibodies recognise target cells, how Fc-dependent and other mechanisms produce cell depletion, and how target-cell biology determines pharmacovigilance assessment. Read Article →
- Cemiplimab: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Cemiplimab is a recombinant human IgG4 monoclonal antibody directed against PD-1. Its effect is blocking PD-1 interaction with PD-L1 and PD-L2. This article explains how the mechanism and treatment context shape case assessment, signal detection, risk management and periodic benefit-risk evaluation. Read Article →
- Brolucizumab: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Brolucizumab is a humanised single-chain antibody fragment that binds vascular endothelial growth factor A. This article explains why its small antibody-fragment format supports high molar dosing in the eye, how VEGF inhibition reduces retinal leakage, and why pharmacovigilance must distinguish molecule-related intraocular inflammation and retinal vasculitis from infectious, vascular, mechanical and disease-related causes of visual deterioration. Read Article →
- Burosumab: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Burosumab is a human IgG1 monoclonal antibody that binds fibroblast growth factor 23. This article explains how phosphate regulation, renal monitoring, skeletal disease and long-term treatment response shape pharmacovigilance. Read Article →
- Canakinumab: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Canakinumab is a fully human monoclonal antibody that neutralises interleukin-1 beta. This article explains why IL-1β is central to autoinflammatory disease, how one cytokine target spans genetically defined periodic fever syndromes, Still’s disease and gout, and how infection, neutropenia, macrophage activation syndrome, DRESS, vaccination and indication-specific disease activity should be handled in pharmacovigilance. Read Article →
- Brodalumab: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Brodalumab is a recombinant fully human IgG2 monoclonal antibody directed against interleukin-17 receptor A (IL-17RA). This article connects its molecular mechanism and clinical context with event follow-up, causality assessment, signal detection, risk management and product traceability. Read Article →
- Blinatumomab: CD19–CD3 T-cell engagement, acute lymphoblastic leukaemia, and product pharmacovigilance Blinatumomab is a small bispecific antibody construct that bridges CD19-positive B-lineage cells to CD3-positive T cells. This article connects its structure and continuous infusion to efficacy, immune toxicity, medication-error risk, and regulatory surveillance. Read Article →
- Biosimilars: Regulatory Concepts, Development and Pharmacovigilance Understand the scientific and regulatory concept of a biosimilar, the stepwise comparability approach used for EU authorisation, the relationship between a biosimilar and its reference biological medicine, and the implications for pharmacovigilance. Read Article →
- Biosimilars and Generic Medicines: Regulatory and Pharmacovigilance Differences Understand the conceptual and regulatory differences between generic medicines and biosimilars, including active-substance identity, bioequivalence, biological comparability, reference-product evidence and the implications for pharmacovigilance. Read Article →
- Biological Products and Pharmacovigilance: Why Product Characteristics Matter Understand why biological-product pharmacovigilance requires product-specific scientific knowledge, how molecular and manufacturing characteristics influence safety evidence, and how those characteristics connect to product identification, immunogenicity and lifecycle surveillance. Read Article →
- Biosimilars and Generics: Regulatory and Pharmacovigilance Differences Understand why biosimilars are not regulated as conventional generics, how the scientific basis of their development differs, and how those differences affect pharmacovigilance without creating a separate biosimilar PV system. Read Article →
- Biological Medicinal Products: Classification, Development and Pharmacovigilance Understand what makes a medicinal product biological, how biological medicinal products are classified in the EU, how major product families relate to one another, and why their biological and manufacturing characteristics create distinctive pharmacovigilance requirements. Read Article →
- Bimekizumab: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Bimekizumab is a humanised IgG1 monoclonal antibody; dual interleukin-17A and interleukin-17F inhibitor. This article explains how its target, route and clinical context shape case assessment, signal detection, risk management and periodic benefit-risk evaluation. Read Article →
- Bevacizumab: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Bevacizumab is a recombinant humanised IgG1 monoclonal antibody that binds VEGF-A and prevents activation of VEGFR-1 and VEGFR-2. It established ligand neutralisation and tumour angiogenesis inhibition as therapeutic strategies, while revealing a mechanism-linked safety profile that includes hypertension, proteinuria, haemorrhage, thromboembolism, gastrointestinal perforation, impaired wound healing, posterior reversible encephalopathy syndrome, ovarian failure and embryo-fetal toxicity. This article integrates its molecular pharmacology, clinical and regulatory history, safety surveillance and risk-control architecture. Read Article →
- Benralizumab: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Benralizumab is a humanised afucosylated IgG1 kappa monoclonal antibody targeting IL-5 receptor alpha. It combines receptor blockade with enhanced Fc-mediated depletion of eosinophils and basophils, creating a pharmacology distinct from antibodies that neutralise IL-5 itself. Read Article →
- Belimumab: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Belimumab is a fully human IgG1 monoclonal antibody directed against B-lymphocyte stimulator (BLyS/BAFF). Its effect is binding soluble BLyS and reducing survival signals for selected autoreactive B cells. This article explains how those features shape case assessment, signal detection, risk management and periodic benefit-risk evaluation. Read Article →
- Belantamab mafodotin: Mechanism, Clinical Safety and Pharmacovigilance Belantamab mafodotin is an afucosylated humanised IgG1Îş antibody conjugated to the microtubule-disrupting payload mcMMAF. This article connects its 2025 EU authorisation for two multiple-myeloma combination regimens with eye examination and dose-modification requirements, thrombocytopenia, infections, infusion reactions, combination attribution and lifecycle-aware safety review. Read Article →
- Basiliximab: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Basiliximab is a chimeric monoclonal antibody directed against CD25, the alpha chain of the high-affinity interleukin-2 receptor on activated T lymphocytes. This article explains why short-course CD25 blockade can reduce early kidney-allograft rejection without broad lymphocyte depletion, and why pharmacovigilance must separate basiliximab-specific hypersensitivity from the infection, malignancy, graft and metabolic risks of the surrounding transplant immunosuppressive regimen. Read Article →
- Avelumab: Classification, Clinical Context, Safety and Pharmacovigilance Avelumab is an IgG1 monoclonal antibody that binds PD-L1 and can retain Fc-mediated effector activity. Its clinical and safety interpretation depends on the indication, treatment setting and any combination therapy. This article connects those features with case assessment, signal evaluation and ongoing pharmacovigilance. Read Article →
- Atezolizumab–Hyaluronidase Subcutaneous Formulation: Safety and Pharmacovigilance Subcutaneous atezolizumab preserves PD-L1 checkpoint blockade while replacing intravenous infusion with a fixed-dose subcutaneous formulation containing recombinant human hyaluronidase. The immune-mediated safety profile remains fundamentally atezolizumab-driven, but route, preparation, injection-site reactions, switching and wrong-formulation errors create distinct pharmacovigilance questions. Read Article →
- Atezolizumab: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Atezolizumab is a humanised, Fc-engineered IgG1 monoclonal antibody that blocks PD-L1 interaction with PD-1 and B7.1, releasing inhibitory signalling that restrains antitumour T-cell responses. This article explains checkpoint biology, molecular design, tumour and immune-cell PD-L1, treatment context and biomarker use, then connects those concepts to multisystem immune-mediated toxicity, infusion reactions, endocrine events, pneumonitis, hepatitis, colitis, nephritis, neurological and cardiac toxicity, treatment-combination attribution and longitudinal pharmacovigilance. Read Article →
- Antibody–Drug Conjugates: Targeted Cytotoxic Delivery, Mechanisms of Toxicity and Pharmacovigilance Antibody–drug conjugates combine antibody-mediated target recognition with a linked pharmacologically active payload. This article explains how the antibody, linker, payload and conjugation architecture interact; how ADCs deliver and release payload; why efficacy and toxicity cannot be inferred from the antibody target alone; and how pharmacovigilance should analyse target-related, payload-related, distribution-related and product-specific safety signals. Read Article →
- Equine Anti-Thymocyte Globulin: Polyclonal T-Cell Immunosuppression and Pharmacovigilance Equine anti-thymocyte globulin is a heterogeneous polyclonal IgG preparation generated by immunising horses with human thymic lymphocytes. Its broad lymphocyte reactivity produces powerful immunosuppression but also creates distinctive immediate and delayed immune reactions, infection risk and cytopenias. Read Article →
- Anifrolumab: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Anifrolumab is a human IgG1 kappa monoclonal antibody targeting type I interferon receptor subunit 1 (IFNAR1). By blocking signalling from multiple type I interferons through a shared receptor, it reduces a central inflammatory pathway in systemic lupus erythematosus while creating infection, herpes-zoster and hypersensitivity considerations that require disease- and treatment-context interpretation. Read Article →
- Anselamimab: Amyloid-Fibril Targeting, Clinical Development and Pharmacovigilance in AL Amyloidosis Explains why amyloid removal differs from plasma-cell suppression, how the early and randomised evidence should be interpreted, and how to assess adverse events in patients with advanced multiorgan AL amyloidosis. Read Article →
- Amivantamab: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Amivantamab is a fully human EGFR-MET bispecific IgG1 antibody used in selected EGFR-mutant non-small-cell lung cancer. This article explains how dual receptor targeting differs from an EGFR tyrosine-kinase inhibitor, how receptor blockade, downmodulation and Fc-mediated mechanisms contribute to antitumour activity, and why mutation subtype, treatment partner, route and treatment phase are essential to pharmacovigilance. Read Article →
- Alirocumab: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Alirocumab is a fully human IgG1 monoclonal antibody directed against proprotein convertase subtilisin/kexin type 9 (PCSK9). This article connects its molecular mechanism and clinical context with event follow-up, causality assessment, signal detection, risk management and product traceability. Read Article →
- Alemtuzumab: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Alemtuzumab is a recombinant DNA-derived humanised IgG1 kappa monoclonal antibody directed against CD52 expressed on lymphocytes and selected other immune cells. This article connects its molecular mechanism and clinical context with event follow-up, causality assessment, signal detection, risk management and product traceability. Read Article →
- Aflibercept Biosimilar: VEGF-Trap Biology, Retinal Disease, Biosimilarity and Product Pharmacovigilance Pavblu is a biosimilar aflibercept fusion protein used intravitreally to neutralise VEGF-family ligands in retinal vascular disease. This article explains aflibercept structure and mechanism, how biosimilarity is established, why indications can differ by jurisdiction, and how injection-related, ocular, vascular and traceability risks are managed in pharmacovigilance. Read Article →
- Adalimumab: Development, Classification and Mechanism of Action Adalimumab is a recombinant fully human IgG1 monoclonal antibody that binds tumour necrosis factor and prevents productive signalling through TNFR1 and TNFR2. This article places the molecule in historical and structural context, separates established pharmacology from plausible secondary effects, and translates its safety profile into practical pharmacovigilance work. Read Article →
- Abciximab: Classification, History, Mechanism of Action, Safety and Pharmacovigilance Abciximab is the Fab fragment of a chimeric monoclonal antibody that blocks platelet glycoprotein IIb/IIIa, the final common receptor pathway for platelet aggregation. Developed for percutaneous coronary intervention, it became an important early therapeutic-antibody example in cardiovascular medicine. This article explains its molecular design, antiplatelet mechanism, historical clinical role, bleeding and thrombocytopenia risks, and the pharmacovigilance lessons that remain relevant after U.S. marketing discontinuation. Read Article →