治疗性单克隆抗体与印度针对性药物警戒的必要性。
Therapeutic monoclonal antibodies and the need for targeted pharmacovigilance in India.
作者信息
Kalaivani M, Singh Abhishank, Kalaiselvan V
机构信息
a Scientific Assistant; Biologics Section; Indian Pharmacopoeia Commission ; Ministry of Health and Family Welfare (Govt. of India) ; Ghaziabad , India.
出版信息
MAbs. 2015;7(1):276-80. doi: 10.4161/19420862.2014.985547.
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.
越来越多创新型单克隆抗体疗法进入全球市场，生物类似药版本如今也已获批，包括在印度。尽管在获批前已证明其疗效和安全性，但针对性的药物警戒对于识别和评估任何单克隆抗体产品的风险至关重要。我们分析了2011年4月至2014年2月期间通过自发报告系统Vigiflow向国家药品不良反应监测中心-药物警戒计划（NCC-PvPI）报告的与单克隆抗体相关的药品不良反应（ADR）数据，以识别ADR数量最多（包括致命/严重ADR）的单克隆抗体。只有0.72%的报告与单克隆抗体有关。该国虽已批准15种单克隆抗体，但通过Vigiflow报告的只有6种。利妥昔单抗的报告数量很多，且在研究期间未报告与任何单克隆抗体相关的致命/严重ADR。我们的研究表明，药物警戒计划在检测和评估与使用单克隆抗体相关的风险方面是一个有效且强大的系统。
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