Therapeutic monoclonal antibodies and the need for targeted pharmacovigilance in India |
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| Authors: | M Kalaivani Abhishank Singh V Kalaiselvan |
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| Institution: | 1.Scientific Assistant; Biologics Section; Indian Pharmacopoeia Commission; Ministry of Health and Family Welfare (Govt. of India); Ghaziabad, India;2.Research Scholar; Faculty of Pharmacy; Jamia Hamdard; New Delhi, India;3.Principal Scientific Officer; NCC-PvPI; Indian Pharmacopoeia Commission; Ministry of Health and Family Welfare (Govt. of India); Ghaziabad, India |
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| 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. |
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| Keywords: | monoclonal antibody NCC-PvPI Vigiflow spontaneous reporting targeted pharmacovigilance |
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