Comparative Studies on Branded Enoxaparin and a US Generic

Enoxaparin, a complex, biologically derived low-molecular-weight heparin, is approved for a range of clinical indications. This study was carried out to compare the potency profile and pharmacodynamic responses of branded enoxaparin (Lovenox; Sanofi, US) with a generic enoxaparin (enoxaparin sodium injection, USP). Five batches of each product were tested. Although the average molecular weight, anti-factor Xa, and anti-factor IIa potencies were similar for the two products, differences were observed in the in vitro thrombin generation and kinetics of clot formation (P .01) and in the ex vivo pharmacodynamics regarding thrombin generation inhibition (P .029), tissue factor pathway inhibitor release (P .006), and inhibition of the active form of thrombin-activated fibrinolysis inhibitor (P .023). These findings suggest that simple analytical characterization can establish good quality control in manufacturing, but they may not assure similarity in biological performance between the branded and the generic enoxaparin