对美国食品和药物管理局生物类似药可互换性概念和要求的解读

Interpretation of FDA concept and requirement on biosimilar interchangeability

美国食品和药物管理局(FDA)于2017年1月发布了"行业指南:证明与参照药具有可互换性时的考虑事项"的草案,并公开征求意见。此次草案旨在帮助申办者证明蛋白制品与参照药具有可互换性,以支持其按照公共健康服务法案(PHSA)351(k)提交上市许可或补充申请。本文结合FDA历年来生物类似药相关指南文件,重点对草案中生物类似药可互换性的概念和要求进行解读,以供我国在制订生物类似药监管法规时参考。

The US Food and Drug Administration（ FDA） released a draft ＂ Guidance for industry：considerations in demonstrating interchangeability with a reference product＂ for public comments in January2017. This guidance is intended to assist sponsors to demonstrate that a proposed therapeutic protein product is interchangeable with a reference product for the purposes of submitting a marketing application or supplement under section 351（k） of the Public Health Service Act（PHSA）. This paper focuses on the interpretation of the FDA＇s concept and relative requirements on biosimilar interchangeability according to FDA＇s related guidance,with the aim of providing reference for drafting regulation on biosimilar administration in China.