美國食品藥品管理局（FDA）于2020年2月發(fā)布了"供企業(yè)用處方生物參照藥和生物類似藥的促銷說明書和廣告考慮的問題問答指導(dǎo)原則"（草案）。該指導(dǎo)原則主要介紹FDA對生物類似藥促銷資料的撰寫要求，而我國目前尚無類似指導(dǎo)原則。值此我國生物類似藥研制正在興起階段，詳細(xì)介紹該指導(dǎo)原則，期望對這類新興藥物促銷資料的撰寫和監(jiān)管有幫助，以確保其真實(shí)而無誤導(dǎo)性。

FDA issued the Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products Questions and Answers Guidance for Industry (draft) in February 2020. This guidance mainly introduces the FDA's requirements for writing promotional materials of biosimilar products. At present there is no similar guidance in China.Just as the development of biosimilar products in China is in the rising stage, the guidance are introduced in detail, hoping to be helpful for the writing and supervision of the promotional materials of such new products, so as to ensure that they are true and not misleading.