Reflection on quality similarity assessment of Semaglutide biosimilar
10.13200/j.cnki.cjb.004268
- VernacularTitle:关于司美格鲁肽生物类似药质量相似性评价的思考
- Author:
CHENG Suyuan
- Publication Type:Journal Article
- Keywords:
Semaglutide;
Biosimilar;
Quality similarity
- From:
Chinese Journal of Biologicals
2024;37(07):887-896
- CountryChina
- Language:Chinese
-
Abstract:
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.
