《生物类似药研发与评价技术指导原则》(试行)有关情况介绍  

Introduction of the drafting procedure of “Guidelines on Development and Evaluation of Biosimilars(drafting) ”

作　　者：白玉[1] 王海学[1] 谢松梅[1] 高晨燕[1] 尹红章[1] 罗建辉[1] 

机构地区：[1]国家食品药品监督管理总局药品审评中心,北京100038

出　　处：《中国新药杂志》2015年第20期2308-2311,共4页Chinese Journal of New Drugs

基　　金：国家"重大新药创制"科技重大专项(2015ZX09501008)

摘　　要：我国《生物类似药研发与评价技术指导原则》(试行)于2015年2月底发布,在生物制药界引起了广泛的关注和讨论。本文作者作为该指导原则的亲历者,通过回顾该指南的起草背景、起草过程和讨论情况,对指导原则主要框架和内容以及相关需说明的问题进行了详细介绍,期望为本指导原则的执行和后续完善提供参考。＂Guidelines on Development and Evaluation of Biosimilars（ drafting） ＂of China was issued at the end of February,2015. It has been brought about wide attention and discussion since then. As the working group members,we reviewed the drafting background,procedure,comments and suggestions collected. Meanwhile,we summarized the key points concerning the format and content of the guidelines,answered some challenging questions and put forward some problems to be addressed. It is hoped that the paper could provide some reference for understanding,implementing and improvement of the guidelines.

关 键 词：生物类似药 相似性 研发 评价 

分 类 号：R95[医药卫生—药学]