Singh Abhishek, Kalaivani Muthusamy, Srivastava Sushma, Goyal Ramesh K, Gupta Suresh K
Biologics Section, Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare (Government of India), Ghaziabad, India.
Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare (Government of India), Ghaziabad, India.
Ther Innov Regul Sci. 2019 Sep 26:2168479019872144. doi: 10.1177/2168479019872144.
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的疾病和慢性病。这些药物的高昂成本使得患者，尤其是发展中国家的患者难以获得。创新型重组药物产品的专利到期促使多家制造商开发生物类似药或类似生物制品。与仿制药不同，由于生产工艺的差异，这些生物类似药与创新产品并不完全相同；然而，它们在质量特性、生物活性、安全性和疗效方面相似。用于仿制药的监管程序不适用于生物类似药，因为它们是由活细胞产生的大型复杂结构，可能产生基于免疫的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价可变和免疫原性，为此需要一个强大的长期药物警戒系统。美国食品药品监督管理局（USFDA）、欧盟以及中国和印度等新兴制药国家已发布了各种关于生物类似药监管批准和药物警戒的指南。本文介绍了这些国家生物类似药的药物警戒计划，通过自发报告系统讨论了药物警戒中的挑战和机遇，并建议对印度药物警戒计划现有的疑似不良事件报告表进行修订。
