低分子肝素仿制药一致性研究法规现状  

Current Regulatory Situation of Quality Consistency Evaluation for Generic Low Molecular Weight Heparin

作　　者：柳晓芳[1,2] 崔慧斐[1] 

机构地区：[1]山东大学药学院,山东济南250012 [2]东营天东制药有限公司,山东东营257067

出　　处：《食品与药品》2013年第5期353-357,共5页Food and Drug

摘　　要：低分子肝素(LMWH)是一类多组分生化药,其复杂的结构特点决定了其仿制药与原研药一致性研究的必要性。随着LMWH,如依诺肝素钠等原研药专利的到期,各国均发布了针对此类产品仿制药与原研药一致性研究的指导原则。本文综述了各国或各组织发布的指导原则或声明,为LMWH仿制药的研究提供借鉴。Quality consistency evaluation is required for generic low molecular weight heparin （LMWH） because it is a multi-component biochemical medicine. The patents for LMWH have expired or will expire shortly, thus guidelines for quality consistency evaluation of generics have been issued in many countries or regions. In this paper, these guidelines or statements were summarized to provide reference for development of such generics.

关 键 词：低分子肝素 依诺肝素钠 仿制药 一致性 法规 

分 类 号：R973.2[医药卫生—药品]