药学学报, 2021, 56(11): 3190-3197
引用本文:
崔靖#, 韩冬梅#, 徐隆昌, 韦薇*. 曲妥珠单抗生物类似药质量“相似性评价标准”探讨[J]. 药学学报, 2021, 56(11): 3190-3197.
CUI Jing#, HAN Dong-mei#, XU Long-chang, WEI Wei*. The discussion on a proposed quality “similarity assessment criteria” of trastuzumab biosimilar[J]. Acta Pharmaceutica Sinica, 2021, 56(11): 3190-3197.

曲妥珠单抗生物类似药质量“相似性评价标准”探讨
崔靖#, 韩冬梅#, 徐隆昌, 韦薇*
国家药品监督管理局药品审评中心, 北京 100022
摘要:
近年来,我国已经批准了多个生物类似药注册上市。在开展生物类似药药学研究与评价时,候选药与原研药的质量相似性是“生物类似药”药学研究的核心,也是其作为类似药开展注册临床试验及支持上市申请的基础和前提。但是,工业界与监管界在建立质量“相似性评价标准”面临诸多挑战,如: 原研药物可获得批次有限;原研药物在其生命周期内可能发生质量漂移;不同厂家的关键质量属性的检测方法存在差异;用于评价标准制定的统计方法难于统一等。本文以曲妥珠单抗为例,系统整理了原研药生产企业及9家生物类似药生产企业累计的69批原研药数据并进行统计分析,结合产品关键质量属性的风险识别,拟定了曲妥珠单抗质量“相似性评价标准”。该标准经已披露的类似药质量数据验证了其合理性,以期为国内曲妥珠单抗生物类似药的药学开发与评价提供参考。
关键词:    曲妥珠单抗      生物类似药      质量相似性评价标准      关键质量属性      药学评价     
The discussion on a proposed quality “similarity assessment criteria” of trastuzumab biosimilar
CUI Jing#, HAN Dong-mei#, XU Long-chang, WEI Wei*
Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China
Abstract:
In recent years, many biosimilars have been approved marketing authorization in our country. When conducting research and evaluation of biosimilar, the quality similarity between the candidate drugs and the original drugs is the key point of "biosimilar", meanwhile it is the basis for clinical and marketing authorization of biosimilar. However, the industry and regulatory agencies are facing many challenges in establishing quality "similarity assessment criteria", such as: limited batches of original drugs; quality drift caused by manufacture process changes in the life cycle; analytical method of critical quality attributes is different from different manfactures; statistical methods used for establishing assessment criteria are difficult to unify. In the article, the data obtained from 69 lots of chemistry, manufacturing and control (CMC) dossier of trastuzumab originator company and dossiers of 9 biosimilar companies were analyzed. Furthermore, combined with the risk identification of the critical quality attributes of the product, quality "similarity assessment criteria" have been proposed. This standard has been verified by the disclosure of biosimilar quality data, aim to promote the development and evaluation of trastuzumab biosimilar.
Key words:    trastuzumab    biosimilar    quality similarity assessment criteria    critical quality attributes    chemistry, manufacturing and control review   
收稿日期: 2021-07-06
DOI: 10.16438/j.0513-4870.2021-0998
基金项目: 国家“重大新药创新”课题(2015ZX09501008).
通讯作者: 韦薇,Tel:86-10-85243036,E-mail:weiw@cde.org.cn
Email: weiw@cde.org.cn
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