生物类似物政策监管指南原则与要求研究综述——基于欧盟版生物类似物指南  

Review of biosimilar regulatory guidelines and scientific principles: Experiences from European Medicines Agency(EMA) guidelines

作　　者：陈名[1,2] 邵蓉[1,2] 

机构地区：[1]中国药科大学国际医药商学院,江苏南京211198 [2]中国药科大学国家药物政策与医药产业经济研究中心,江苏南京211198

出　　处：《中国卫生政策研究》2014年第10期21-26,共6页Chinese Journal of Health Policy

摘　　要：本文通过文献综述,在明确界定生物类似物概念的基础上,阐述了生物药的特点及其研发生产过程。基于欧盟版生物类似物指南,介绍了其政策框架,并系统梳理了生物类似物政策监管指南原则与要求,包括生物相似性、安全性和免疫原性、适应症外推法、标签与命名、数据保护以及药物互换性与药物警戒等内容,旨在为促进我国生物类似物与生物制药产业的进一步发展提供政策参考与建议。In this study, a literature review was adopted to specify terminology of biosimilars and demonstrate the basic characteristic of biologics and relevant research and development （ R＆D） procedures. The regulatory framework of the European Medicines Agency （ EMA ） guidelines on biosimilars was introduced. Explicitly, regulatory guidelines and scientific principles, regarding biosimilarity, safety and immunogenicity, extrapolation, labels and names, data protection, were systematically introduced, as well as interchangeability and pharmacovigilance, respectively. The purpose of the study is to provide regulatory references for Chinese legislators and recommendations on the R＆amp;D of biosimilars in the biopharmaceutical industry.

关 键 词：生物类似物 欧盟 欧洲药品管理局 监管指南 技术要求 

分 类 号：R197[医药卫生—卫生事业管理]