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The aims of this paper are to discuss the: (1) pharmacology of low-molecular-weight heparins (LMWHs) emphasizing their synthesis, mechanism of action, and comparison with the parent compound, unfractionated heparin (UFH); and (2) recent controversial approval by the Food and Drug Administration (FDA) of a generic enoxaparin. Enoxaparin is one of several LMWHs that are currently available worldwide for clinical use. LMWHs are derived by chemi- cal or enzymatic depolymerization of the "parent" molecule, UFH. Both UFH and LMWHs exert their primary antithrombotic effect by binding to and catalyzing the naturally-occurring anticoagulant, antithrombin. LMWHs are more effective at inhibiting factor Xa than factor IIa (thrombin). They also produce less heparin-induced thrombocytopenia and osteoporosis than UFH and are at least as effective and safe as UFH for each approved indication. They are safe and effective when given subcutaneously once or twice daily, without the need for anticoagulant monitoring, and are suitable for out-of-hospital treatment. The FDA first approved enoxaparin (Lovenox ®

The development and introduction of biosimilar anticoagulants &ndash; focus on enoxaparin

The development and introduction of biosimilar anticoagulants – focus on enoxaparin