生物仿制药的药物警戒-为什么它与仿制药和创新生物制品不同?

B Oza, S Radhakrishna, P Pipalava, V Jose
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引用次数: 5

摘要

生物仿制药自2000年起在印度上市。与生物制品一样,生物仿制药体积大、结构复杂、制造过程复杂,而且是在活体中生产的。它需要专门的给药装置,并且需要更严格的温度控制以防止降解。由于生物类似物的开发遵循缩短的途径,临床试验中以前未知的不良事件(AE)可能在上市后被检测到。在印度,2018年1月实施药物警戒指南后,对药物警戒的认识显著提高。然而,生物制剂需要更严格的监测,以确保其安全性和有效性。这篇综述文章讨论了生物仿制药药物警戒的重要性,以及它与仿制药的区别,并为临床医生和研究人员提供了建议,以提高对生物仿制药的药物警戒的不同方法的需求。生物仿制药的药物警戒与创新生物制品一样重要,比仿制药更重要。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Pharmacovigilance of biosimilars - Why is it different from generics and innovator biologics?

Biosimilars are being marketed in India since 2000. Like biologics, biosimilars have a large size, complex structure, and complicated manufacturing process, and they are produced in a living organism. It requires specialized delivery devices for administration and needs tighter temperature control to prevent degradation. As biosimilar development follows abbreviated pathway, adverse events (AEs) previously unknown during a clinical trial may be detected postmarketing. In India, the awareness on pharmacovigilance has increased significantly after implementation of the pharmacovigilance guidance in January 2018. However, biologics require tighter monitoring to ensure their safety and efficacy. This review article discusses the importance of pharmacovigilance for biosimilars, how it is different from generics, and provides recommendations to sensitize clinicians and researchers about the requirement of a different approach to improve pharmacovigilance for biosimilars. Pharmacovigilance for biosimilars is as important as it is for innovator biologics and more important than that for generics.

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