生物類似藥是指在質(zhì)量、安全性和有效性方面與已獲準(zhǔn)上市的參比制劑具有相似性的治療性生物制品。結(jié)合美國、歐盟、日本和世界衛(wèi)生組織對生物類似藥研發(fā)及監(jiān)管思路，重點(diǎn)介紹了2018年度美國食品藥品監(jiān)督管理局發(fā)布的《生物類似藥行動(dòng)計(jì)劃——簡介和概述：創(chuàng)新與競爭間的平衡》，以期對我國生物類似藥監(jiān)管政策的制定提供借鑒。

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.