美國(guó)食品藥品監(jiān)督管理局（FDA）于2018年7月發(fā)布了"供企業(yè)用生物類(lèi)似藥說(shuō)明書(shū)指導(dǎo)原則"。該指導(dǎo)原則提出了起草生物類(lèi)似藥說(shuō)明書(shū)的一般原則，并對(duì)生物類(lèi)似藥說(shuō)明書(shū)的內(nèi)容提出了許多具體建議。而我國(guó)目前尚無(wú)類(lèi)似的指導(dǎo)原則。詳細(xì)介紹FDA的該指導(dǎo)原則主要內(nèi)容，對(duì)我國(guó)撰寫(xiě)、閱讀和監(jiān)管生物類(lèi)似藥說(shuō)明書(shū)有重要的參考價(jià)值。

FDA issued Labeling for Biosimilar Products Guidance for Industry in July 2018. This guidance puts forward the general principle of drafting the biosimilar products labeling, and submits many specific suggestions on the content of the biosimilar products labeling. And our country does not have similar guidance at present. This article describes in detail the FDA guidance for writing, reading and supervising biosimilar products labeling, which has important reference value in China.