title: Therapeutic monoclonal antibodies and the need for targeted pharmacovigilance in India.
abstract: A growing number of innovative mAb therapeutics are on the global market, and biosimilar versions have now also been approved, including in India. Although efficacy and safety is demonstrated prior to approval, targeted pharmacovigilance is essential for the identification and assessment of risk for any mAb products. We analyzed the ADR data related to mAbs reported to the NCC-PvPI through the spontaneous reporting system Vigiflow during April 2011 to February 2014 to identify mAbs with the highest number of ADR including fatal/serious ADR. Only 0.72% reports were related to mAbs. Although 15 mAbs are approved in the country, only 6 mAbs were reported through Vigiflow. Rituximab was highly reported, and no fatal/serious ADR related to any mAbs were reported during the study period. Our study shows that PvPI is effective and robust system in the detection and assessment of risks associated with the use of mAbs.
authors.affiliation: a Scientific Assistant; Biologics Section; Indian Pharmacopoeia Commission ; Ministry of Health and Family Welfare (Govt. of India) ; Ghaziabad , India.
authors.forename: M
authors.initials: M
authors.lastname: Kalaivani
authors.forename: Abhishank
authors.initials: A
authors.lastname: Singh
authors.forename: V
authors.initials: V
authors.lastname: Kalaiselvan
mesh_terms: D000911:Antibodies, Monoclonal / Q000009:adverse effects* / Q000627:therapeutic use*; D006801:Humans; D007194:India; D060735:Pharmacovigilance
chemical_list: D000911:Antibodies, Monoclonal
keywords: ADR, adverse drug reactions; ADR/E, adverse drug reactions/event; AMCs, ADR monitoring centers; CDSCO, Central Drugs Standard Control Organization; CLL, chronic lymphocytic leukemia; DCGI, Drug Controller General of India; EMA, European Medicines Agency; EU, European Union; GEAC, Genetic Engineering Appraisal Committee; HBV, hepatitis B virus; ICSRs, Individual Case Safety Reports; IPC, Indian Pharmacopoeia Commission; MHRA, Medicines and Healthcare Products Regulatory Agency; MedDRA, Medical Dictionary for Regulatory Activities; MoEF, Ministry of Environment and Forests; MoHFW, Ministry of Health and Family Welfare; NCC-PvPI; NCC-PvPI, National Coordination Centre-Pharmacovigilance Program of India; NHL, non Hodgkin lymphoma; NRA, National Regulatory Authority; PML, progressive multifocal leukoencephalopathy; PSUR, Periodic Safety Updates Report; RCGM, Review Committee on Genetic Manipulation; SOC, System Organ Class; US, Unites States of America; USFDA, United States Food and Drug Administration; Vigiflow; WHO, World Health Organization; mAb, monoclonal antibody; mAbs, monoclonal antibodies; monoclonal antibody; rDNA, recombinant DNA; spontaneous reporting; targeted pharmacovigilance