美國(guó)食品藥品管理局（FDA）于2016年12月發(fā)布了“供企業(yè)用支持證明與參照藥有生物相似性的臨床藥理學(xué)數(shù)據(jù)指導(dǎo)原則”，說明了對(duì)生物類似藥臨床藥理學(xué)研究的試驗(yàn)設(shè)計(jì)和試驗(yàn)方法的要求，特別指出研究中應(yīng)特別注意的問題。而我國(guó)尚無類似的指導(dǎo)原則，介紹FDA該指導(dǎo)原則，希望對(duì)我國(guó)這方面的研究和監(jiān)管有益。

FDA released "Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product Guidance for Industry" in December, 2016. The guidance describes the requirements of the trial designs and trial methods for the biosimilar clinical pharmacological studies, and especially points out the problems that should be paid special attention to in the studies. However there is no similar guidance in China. This paper introduces the guidance of FDA, which is beneficial to the research and regulation in China.