FDA对少于参照药适应症生物类似药许可证申请的建议

FDA's recommendations for license application of biosimilar drugs with fewer indications than reference drugs

美国食品药品监督管理局(FDA)于2020年2月发布了“供企业用生物类似药和可互换的生物类似药:少于已许可的参照药所有使用条件的许可证指导原则(草案)”。该指导原则主要对少于参照药适应症的生物类似药申报注册类别和说明书的内容提出了建议。介绍该指导原则的内容,期望能扩大我国对这类药物研发和监管的视野。

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.