美國(guó)食品藥品監(jiān)督管理局（FDA）于2020年2月發(fā)布了“供企業(yè)用生物類(lèi)似藥和可互換的生物類(lèi)似藥：少于已許可的參照藥所有使用條件的許可證指導(dǎo)原則（草案）”。該指導(dǎo)原則主要對(duì)少于參照藥適應(yīng)癥的生物類(lèi)似藥申報(bào)注冊(cè)類(lèi)別和說(shuō)明書(shū)的內(nèi)容提出了建議。介紹該指導(dǎo)原則的內(nèi)容，期望能擴(kuò)大我國(guó)對(duì)這類(lèi)藥物研發(fā)和監(jiān)管的視野。

FDA issued the Biosimilars and Interchangeable Biosimilars:Licensure for Fewer Than All Conditions of Use for Which the Reference Product Has Been Licensed Guidance for Industry (Draft) in february 2020. This guidance mainly provides recommendations on the applicational registration categories and labelinges for biosimilars fewer than the indications of reference products. This paper introduces the guidance in detail, hoping to expand the vision of research and development as well as supervision of such drugs in China.