生物类似药与参照药可比性评价的分析策略  

Analytical Strategies for Assessing Comparability of Biosimilars and Reference Products

作　　者：王雅雯[1] 郑丽娥[1] 粟晓黎[1] 邹宇玲[1] 范玉明[1] 

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《中国药事》2016年第4期321-330,共10页Chinese Pharmaceutical Affairs

摘　　要：国内外的药品管理机构均要求生物类似药与一个参照药具有适当可比性的质量、安全和功效。生物类似药开发商需要采用先进的分析技术,描述生物类似药的特征,并与相关的上市参照药比较;目前,可以应用多种分析方法,研究候选生物类似药与参照药的特性,这些方法学可以作为评价生物可比性的证据。本文主要讨论支持生物类似药可比性检验能够采取的分析技术。Domestic and international regulatory authorities require biosimilars to have appropriate and comparable quality, safety and efficacy with a reference product. The analytical techniques that are available to developer of biosimilar are well advanced and characterize the biosimilars and compare them with the relevant marketed reference product. This variety of analytical methods can be used to investigate the attributes of a candidate biosimilar and a reference product. These analytical methodologies enable evidence for biocomparability to be assessed. This review discusses mainly the analytical techniques available to support comparability testing of biosimilars.

关 键 词：生物类似药 参照药 可比性评价 分析技术 

分 类 号：R95[医药卫生—药学]