Biologics Section, Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare (Government of India), Sector-23, Raj Nagar, Ghaziabad, 201002, India.
Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare (Government of India), Ghaziabad, India.
Ther Innov Regul Sci. 2020 May;54(3):667-680. doi: 10.1007/s43441-019-00101-6. Epub 2020 Jan 6.
Recombinant drug products successfully treat many life-threatening and chronic diseases. The high cost of these drugs makes them inaccessible to the patients particularly in developing countries. Patent expiration of innovator recombinant drug products has led to the development of biosimilars or similar biologics by several manufacturers. Unlike generics, these are not identical to their innovator products because of the differences in the manufacturing process; however, they are similar in quality characteristics, biological activity, safety, and efficacy. The regulatory procedures used for generic drugs cannot be applied for biosimilars as they are large complex structures produced from living cells and can produce potential risk of immune-based adverse reactions. Out of several safety issues related to biosimilars, two main safety concerns are variable potency and immunogenicity, for which a robust long-term pharmacovigilance system is needed. Various guidelines have been issued for the regulatory approval and pharmacovigilance of biosimilars by USFDA, EU, and pharma-emerging countries like China and India. The article includes the pharmacovigilance plan of biosimilars in these countries, discusses the challenges and opportunities in pharmacovigilance through spontaneous reporting systems, and suggests amendments in the existing suspected adverse event reporting form of the Pharmacovigilance Programme of India.
重组药物产品成功治疗了许多危及生命和慢性疾病。这些药物的高成本使得它们无法为患者所获得，特别是在发展中国家。创新型重组药物产品的专利到期后，几家制造商开发了生物类似药或类似的生物制剂。与仿制药不同，由于制造工艺的差异，它们与创新产品并不完全相同；但是，它们在质量特性、生物活性、安全性和疗效方面是相似的。用于仿制药的监管程序不能用于生物类似药，因为它们是由活细胞产生的复杂结构，可能会产生免疫相关不良反应的潜在风险。在与生物类似药相关的几个安全问题中，两个主要的安全问题是效力可变和免疫原性，需要建立一个强大的长期药物警戒系统。美国 FDA、欧盟以及中国和印度等制药新兴国家为生物类似药的监管批准和药物警戒发布了各种指南。本文包括这些国家的生物类似药药物警戒计划，讨论了通过自发报告系统进行药物警戒的挑战和机遇，并建议修改印度药物警戒计划现有的可疑不良事件报告表。
