Update of the Recommendations on Biosimilar Low-Molecular-Weight Heparins from the Scientific Subcommittee on Control of Anticoagulation of the ISTH.
J Thromb Haemost. 2013 Apr 24;
Authors: Harenberg J, Walenga J, Torri G, Dahl O, Drouet L, Fareed J, The Subcommittee on Control of Anticoagulation of the Scientific Standardization Committee of the International Society on Thrombosis Haemostasis
Abstract
Biosimilar low-molecular-weight heparins (LMWH) have been produced in the past years and are currently being marketed in China, India, Argentina and Brasil. The United States Food and Drug Administration (FDA) has approved two biosimilar versions of enoxaparin for clinical use in any indication where the originator product had achieved approval ((1,2,3,4) ). Of note is that each originator LMWH had received regulatory approval as an individual biological medicine and large randomized clinical trials were required for each clinical indication. This article is protected by copyright. All rights reserved.
PMID: 23615078 [PubMed - as supplied by publisher]