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  • Title: Comparative studies on branded enoxaparin and a US generic version of enoxaparin.
    Author: Walenga JM, Jeske WP, Hoppensteadt D, Cunanan J, Khan H, Escalante V, Fareed J, Bakhos M.
    Journal: Clin Appl Thromb Hemost; 2013 Jun; 19(3):261-7. PubMed ID: 23091283.
    Abstract:
    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.
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