关于司美格鲁肽生物类似药质量相似性评价的思考

Reflection on quality similarity assessment of Semaglutide biosimilar

随着司美格鲁肽注射液(Ozempic^(?))以及司美格鲁肽片(Rybelsus^(?))原研药在我国上市,国内生物医药企业按照生物类似药路径开发的司美格鲁肽生物类似药日渐增多。本文梳理了司美格鲁肽原研药及生物类似药国内外注册与研发现状,分析了司美格鲁肽质量研究和质量相似性评价中的挑战及相关技术要求,结合审评实践对司美格鲁肽生物类似药的药学评价中常见问题进行分析探讨,以期为此类生物类似药的药学开发与评价提供参考。

With the development of Semaglutide Injection(Ozempic~?)and Rybelsus~?,also known as(Semaglutide Tablets?),the original research drugs have been listed in China,and domestic biopharmaceutical companies are developing an increasing number of Semaglutide biosimilar drugs according to the biosimilar drug pathway.This paper reviews the current status of registration and research and development of original research drugs and biologically similar drugs of Semaglutide both domestically and internationally,analyzes the challenges and related technical requirements in quality research and quality similarity evaluation of Semaglutide,and combines the evaluation practice to analyze and explore common problems in pharmaceutical evaluation of Semaglutide biologically similar drugs,in order to provide reference for the pharmaceutical development and evaluation of such biologically similar drugs.