国外生物类似药监管政策发展分析及对我国的启示.PDF

国外生物类似药监管政策发展分析及对我国的启示 ＊ # 酒 励 ，何 霞，李 伟（中国药科大学国际医药商学院，南京 211198） 中图分类号 R95 文献标志码 A 文章编号 1001-0408（2016）01-0008-04 DOI 10.6039/j.issn. 1001-0408.2016.01.03 摘 要 目的：了解国外生物类似药监管政策发展现状，为我国生物类似药监管政策的完善提供参考。方法：对世界卫生组织 （WHO ）、欧盟药管局（EMA ）、美国FDA 发布的生物类似药相关政策或指南中关于生物类似药定义、参比药品选择、质量研究、非 临床研究、临床研究等方面的内容进行比较分析。结果与结论：国外生物类似药监管政策具有3点共性，一是允许生物类似药与 参比药品存在一定的差异性；二是逐项对比生物类似药与参比药品的安全性与有效性，确保质量研究的可靠；三是在证实质量的 高度相似性前提下减少非临床及临床试验。对比我国这方面的发展现状，应该从提高参比药品选择的针对性、细化临床前与临床 研究指南及建立上市后配套制度等方面进行完善。 关键词 生物类似药；监管政策；比较研究；完善 Analysis of the Regulatory Policies Progress of Biosimilars in Foreign Countries and Its Enlightenment to China JIU Li ，HE Xia ，LI Wei （School of International Pharmaceutical Business ，China Pharmaceutical University ，Nan- jing 211198，China ） ABSTRACT OBJECTIVE ：To explore the development status of regulatory policies of biosimilars in foreign countries ，and to provide reference for perfecting biosimilars regulatory policies in China. METHODS ：Comparative analysis was conducted ，con- cerning biosimilar regulations and directories which had been issued by WHO ，EMA and FDA ，in aspects of biosimilars definition ， the choice of reference drug ，quality studies ，non-clinical studies ，clinical studies. RESULTS CONCLUSIONS ：Three common points found in foreign regulatory policies were that ：firstly ，discrepancies were allowed between biosimilars and reference drugs ； secondly ，the comparison was itemized between biosimilars and reference drugs on safety and effectiveness ，in order to guarantee the reliability of quality research ；thirdly ，clinical and non-clinical studies were reduced with a premise that similarity is confirmed. Given China ’s current situation ，several parts of policies should be improved ，including stressing pertinence of reference drug selec- tion ，refining preclinical and clinical study directories and establishing