刍议美国生物类似药行动计划

Discussion on FDA's Biosimilar Action Plan

生物类似药是指在质量、安全性和有效性方面与已获准上市的参比制剂具有相似性的治疗性生物制品。结合美国、欧盟、日本和世界卫生组织对生物类似药研发及监管思路,重点介绍了2018年度美国食品药品监督管理局发布的《生物类似药行动计划——简介和概述:创新与竞争间的平衡》,以期对我国生物类似药监管政策的制定提供借鉴。

A biosimilar product is a biological product based on a showing that it is highly similar to an approved biological product, known as a reference product, and has no clinically meaningful differences in terms of safety and effectiveness from the reference product. In this paper, the US, EU, Japan and the World Health Organization's thoughts on the research, development and supervision of biosimilar are reviewed. And then we focused on the U.S. Food and Drug Administration's Biosimilar Action Plan — Introduction and Overview: Balancing Innovation and Competition , in order to provide references for the formulation of regulatory policies for biosimila in China.