Journal
DRUG DISCOVERY TODAY
Volume 18, Issue 5-6, Pages 305-311Publisher
ELSEVIER SCI LTD
DOI: 10.1016/j.drudis.2012.11.002
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The protection rights of low molecular weight heparins (LMWHs) are expired or are expiring, so the extent and nature of the studies required to obtain a market authorization for LMWH copies represents a hot topic. FDA classifies LMWHs as semisynthetic drugs and their copies as generics whereas the EMA views them as biological medicines and consequently their copies as biosimilars. Consequently, FDA requires only in vivo pharrnacodynamic studies, while EMA requires also clinical trials. The current work reviews the chemical composition and therapeutic indications of LMWs available in the EU and USA markets to discuss the two different approaches. Because LMWHs show a high intrinsic variability and a complete characterization is not viable, a conservative approach is desirable.
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