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Therapeutic monoclonal antibodies and the need for targeted pharmacovigilance in India

M Kalaivani1, Abhishank Singh, V Kalaiselvan

  • 1a Scientific Assistant; Biologics Section; Indian Pharmacopoeia Commission ; Ministry of Health and Family Welfare (Govt. of India) ; Ghaziabad , India.

Mabs
|December 20, 2014
PubMed

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.

Keywords:
ADR, adverse drug reactionsADR/E, adverse drug reactions/eventAMCs, ADR monitoring centersCDSCO, Central Drugs Standard Control OrganizationCLL, chronic lymphocytic leukemiaDCGI, Drug Controller General of IndiaEMA, European Medicines AgencyEU, European UnionGEAC, Genetic Engineering Appraisal CommitteeHBV, hepatitis B virusICSRs, Individual Case Safety ReportsIPC, Indian Pharmacopoeia CommissionMHRA, Medicines and Healthcare Products Regulatory AgencyMedDRA, Medical Dictionary for Regulatory ActivitiesMoEF, Ministry of Environment and ForestsMoHFW, Ministry of Health and Family WelfareNCC-PvPINCC-PvPI, National Coordination Centre-Pharmacovigilance Program of IndiaNHL, non Hodgkin lymphomaNRA, National Regulatory AuthorityPML, progressive multifocal leukoencephalopathyPSUR, Periodic Safety Updates ReportRCGM, Review Committee on Genetic ManipulationSOC, System Organ ClassUS, Unites States of AmericaUSFDA, United States Food and Drug AdministrationVigiflowWHO, World Health OrganizationmAb, monoclonal antibodymAbs, monoclonal antibodiesmonoclonal antibodyrDNA, recombinant DNAspontaneous reportingtargeted pharmacovigilance

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