里扎·阿德列提别克 邵蓉

    摘 要 在鼓励生物类似药的发展中，适应证外推是一个关键概念。生物类似药审批过程严格，但生物类似药的接受程度仍然很低。欧盟是生物类似药发展的先驱，对生物类似药适应证外推具有科学及合理的监管。本文通过文献研究以及相关案例分析，了解欧盟生物类似药适应证外推的内涵，提炼出适应证外推所考虑的因素，以期为我国生物类似药的发展提供借鉴。

    关键词 生物类似药 适应证外推 科学证据 欧盟

    中图分类号：R951 文献标志码：C 文章编号：1006-1533(2021)01-0055-03

    *基金项目：国家社会科学基金重大项目(15ZDB167)

    Study on the scientificity and rationality of the extrapolation of indications for biosimilars in the EU*

    ADELIETIBIEKE Lizha**， SHAO Rong***

    (Research Center of National Drug Policy & Ecosystem， China Pharmaceutical University， Nanjing 210009， China)

    ABSTRACT Extrapolation is a key concept in the development of biosimilars. However， the acceptability of indication extrapolation continues to be low in the clinical setting due to the special characteristic of biosimilars. The European Union is a pioneer in the development of biosimilars， and has founded scientific and reasonable regulation system for the safe use of biosimilars. The connotation of biosimilar extrapolation is understood and the factors considered of extrapolation is extracted by literature research and related case analysis so as to provide reference for the development of biosimilars in China. ......