摘要
目的 以阿达木单抗为案例,探讨生物类似药质量相似性评价和适应症外推的药学考量,以期为工业界和监管机构研究和评价提供参考。方法 通过调研国内外已获批阿达木单抗生物类似药申报情况,结合研发和审评实践,对阿达木单抗质量属性风险分级及相似性评价方法进行简要介绍,着重讨论药学相似性评价要素的内容和基本考量,并阐述适应症外推的药学考虑。结果与结论阿达木单抗质量相似性研究是其整体相似性评价的基础,也是适应症外推的前提;针对药学比对研究中所观察到的候选药和参照药之间的质量差异,应考虑产品质量属性之间的关联性,并结合非临床和/或临床证据科学论证质量差异是否具有临床意义。
OBJECTIVE To explore the biosimilarity assessment and chemistry manufacture and control(CMC) consideration for indication extrapolation of adalimumab biosimilars. METHODS Through the investigation of approved adalimumab biosimilars at home and abroad, combined with authors′ the research and development and review experience, the article briefly introduced risk classification and similarity evaluation methods of the quality attributes of adalimumab, focused on the content and basic considerations of the CMC similarity evaluation elements, and expounded the CMC considerations for indication extrapolation.RESULTS AND CONCLUSION The study of adalimumab biosimilarity in quality perspective is the basis of biosimilar overall similarity evaluation, as well as the premise of indication extrapolation. For the differences in quality between proposed product and reference product, the correlation among product quality attributes should be considered, and whether the clinically meaningful differences should be scientifically demonstrated in conjunction with non-clinical and/or clinical evidence.
作者
徐刚领
宋丽娜
葛玉梅
唐崇淇
谢松梅
XU Gang-ling;SONG Li-Na;GE Yu-Mei;TANG Chong-qi;XIE Song-Mei(Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China;Division of Monoclonal Antibodies,National Institutes for Food and Drug Control,NHC Key Laboratory of Research on Quality and Standardization of Biotechnology Products,NMPA Key Laboratory for Quality Research and Evaluation of Biological Products,Beijing 102629,China)
出处
《中国药学杂志》
CAS
CSCD
北大核心
2022年第23期1967-1973,共7页
Chinese Pharmaceutical Journal
