Biosimilars of low molecular weight heparins (LMWHs) are more alike the originator than different branded LMWHs. The latter differ largely in molecular weight, anti-FXa/anti-FIIa ratio and antithrombin binding. The Food and Drug Administration and European Medicines Agency guidelines are sufficient for the clinical use of high quality LMWHs. However, the Food and Drug Administration guideline lacks the results of a phase I clinical trial in the approval process. Most information about biosimilars is available for enoxaparin given that many biosimilars of enoxaparin have received market access. The guidelines of many International Thrombosis Societies for LMWH biosimilars are too stringent, not updated and impractical for formulary uptake discussions. This review gives background information on critical factors for the formulary uptake process of LMWHs with special attention for the use of the System of Objectified Judgment Analysis/Infomatrix model.

译文

低分子量肝素(LMWHs)的生物仿制药比不同品牌的LMWHs更相似。后者在分子量,抗FXa /抗FIIa比率和抗凝血酶结合方面有很大不同。食品药品监督管理局和欧洲药品管理局的指南足以用于高质量LMWH的临床使用。但是,美国食品药品监督管理局的指南缺乏批准过程中第一阶段临床试验的结果。鉴于许多依诺肝素的生物仿制药已获得市场准入,因此有关依诺肝素的大多数生物仿制药信息均可用。许多国际血栓形成协会关于LMWH生物仿制药的指导方针过于严格,没有更新,对于配方吸收的讨论不切实际。这篇综述提供了有关LMWHs配方摄入过程关键因素的背景信息,并特别注意使用客观判断分析/信息矩阵模型系统。

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