摘要
目的完善我国生物仿制药注册制度。方法对欧洲生物仿制药审批指南体系和美国有望出台的BPCIA法案进行对比研究,并借鉴欧美经验指导我国实践。结果作为大分子药品,生物制品在药理特性、制备工艺等方面具有众多特性,这使生物仿制药注册必须进行更加精细的生物等效性验证。结论生物等效性验证不能直接被套用于生物仿制药注册,有必要对其进行更加严格的临床前和临床研究。
Objective To consummate the biosimilar approval system in our country. Methods Develop a comparative analysis with the biosimilar approval guidelines system in EU and the forthcoming BPCIA in the US, and use the experiences from US and EU to instruct domestic practice. Results As multimolecule drug, the nature of biologics makes the bioequivalence of biosimilar more difficult. Conclusions Bioequivalence approval can＇t be used in biosimilar approval system, and it is necessary to conduct more district pre-clinical and clinical trials.
出处
《中国药事》
CAS
2009年第8期819-821,共3页
Chinese Pharmaceutical Affairs
