Department of Chemical Engineering, Indian Institute of Technology, Delhi, India.
Department of Clinical Pharmacy, University of Michigan College of Pharmacy, Ann Arbor, USA.
Expert Opin Drug Saf. 2021 Mar;20(3):265-274. doi: 10.1080/14740338.2021.1876024. Epub 2021 Feb 18.
Biosimilar medicines have transformed the healthcare landscape by providing improved access to life-saving medicines at a lower cost. Biosimilars are a distinct category of biologic therapeutics that enter the market after patent expiration of a reference molecule. Regulatory bodies worldwide have developed guidance to expedite the approval and entry of these drugs to the market. Biosimilar approval is based on a totality of the evidence approach, demonstrating similarity between the biosimilar and the originator in terms of physicochemical properties, quality characteristics, biological activity, safety, and efficacy. This article provides an overview of the biosimilar regulatory guidelines and discusses the importance and considerations of comparative clinical studies that are performed during biosimilar development. Two review assessment reports, one each from the EMA and the FDA, are presented. The discussed case studies illustrate the importance of pharmacokinetic and pharmacodynamic studies in the regulatory approval of biosimilars. It is crucial for biosimilar developers to judiciously determine clinical parameters including biomarkers, endpoints, and acceptance criteria before executing clinical studies.
生物类似药通过降低成本，提高了救命药物的可及性，从而改变了医疗保健格局。生物类似药是一种独特的生物治疗药物类别，在参照分子专利到期后进入市场。全球监管机构已经制定了指导方针，以加快这些药物的批准和上市。生物类似药的批准基于整体证据方法，证明生物类似药与原研药在理化性质、质量特性、生物活性、安全性和疗效方面具有相似性。本文概述了生物类似药的监管指南，并讨论了在生物类似药开发过程中进行比较临床研究的重要性和考虑因素。本文呈现了来自 EMA 和 FDA 的两份审查评估报告。讨论的案例研究说明了药代动力学和药效学研究在生物类似药监管批准中的重要性。对于生物类似药开发者来说，在执行临床研究之前，明智地确定包括生物标志物、终点和接受标准在内的临床参数至关重要。
