生物类似药临床用药互换的思考与建议  

Consideration and suggestion on clinical drug switching of biosimilars in China

作　　者：徐子悦 韩晟[2] 管晓东[1,2] 史录文[1,2] XU Zi-yue;HAN Sheng;GUAN Xiao-dong;SHI Lu-wen(School of Pharmaceutical Sciences y Peking University,Beijing 100191,China;International Research Center for Medicinal Administration,Peking University,Beijing 100191,China)

机构地区：[1]北京大学药学院,北京100191 [2]北京大学医药管理国际研究中心,北京100191

出　　处：《中国新药杂志》2021年第17期1554-1558,共5页Chinese Journal of New Drugs

摘　　要：本文旨在为中国生物类似药上市后临床用药互换监管政策与实践提出建议。查阅文献和相关政策,简述中国生物类似药发展现状,梳理欧美生物类似药可互换性监管经验和临床用药互换研究进展。中国生物类似药发展迅速,但相关制度建设仍需完善。欧美国家已初步建立生物类似药临床用药互换监管制度,但目前实践经验和研究证据有限,专家共识尚未建立。生物类似药与原研生物药在临床可互换性上仍存在争议,监管机构需重视生物类似药临床用药互换安全性问题,应建立并完善临床数据公开、可互换性评价、药品命名溯源、互换激励制度等相关政策。The aim of this article is to make some suggestions for the regulations on interchangeability and clinical drug switching of biosimilar in China.Literature and relevant policies were reviewed.The development status of biosimilars in China was summarized,the regulatory experiences on the interchangeability of biosimilars in the United State and European Union were combed,and research findings on clinical drug switching were analyzed as well.Biosimilars have developed rapidly in China,but the related regulatory system has not been completely established.The United States and European Union have already initially established the management of biosimilar interchangeability,while the practical experience and clinical evidence are limited,and expert consensus has not been reached.There are still potential risks and concerns on switching from an originator biologic to a biosimilar or from one biosimilar to another.Drug regulatory authority should pay more attention to drug safety,clinical data information transparency,and technical guidelines on interchangeability,drug traceability,and incentive system.

关 键 词：生物类似药 原研生物药 临床用药互换 可互换性 

分 类 号：R95[医药卫生—药学]