美國(guó)食品藥品管理局（FDA）于2019年5月發(fā)布了“供企業(yè)用證明與參照藥可互換性考慮的問題的指導(dǎo)原則”（正式版本）。該指導(dǎo)原則介紹了FDA對(duì)治療性蛋白質(zhì)產(chǎn)品與參照藥可互換性研究的原則要求和具體研究數(shù)據(jù)和信息的要求。而中國(guó)目前尚無類似指導(dǎo)原則。詳細(xì)介紹該指導(dǎo)原則主要內(nèi)容，期望對(duì)我國(guó)這方面的研究和監(jiān)管能走在世界前列有所幫助。

FDA issued the Considerations in Demonstrating Interchangeability With a Reference Product Guidance for Industry (final) in May 2019. This guidance introduces the FDA's requirements on the principles and the specific research data and information of interchangeability between therapeutic protein products and reference products. There is no similar guidance at present in China. This paper introduces the guidance in detail, hoping that it will be helpful for our research and supervision in this field to lead the world.