title: Comparative studies on branded enoxaparin and a US generic version of enoxaparin.
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.
authors.affiliation: Department of Thoracic & Cardiovascular Surgery, Loyola University Chicago, Maywood, IL 60153, USA. jwaleng@lumc.edu
authors.forename: Jeanine M
authors.initials: JM
authors.lastname: Walenga
authors.forename: Walter P
authors.initials: WP
authors.lastname: Jeske
authors.forename: Debra
authors.initials: D
authors.lastname: Hoppensteadt
authors.forename: Josephine
authors.initials: J
authors.lastname: Cunanan
authors.forename: Hussein
authors.initials: H
authors.lastname: Khan
authors.forename: Vicki
authors.initials: V
authors.lastname: Escalante
authors.forename: Jawed
authors.initials: J
authors.lastname: Fareed
authors.forename: Mamdouh
authors.initials: M
authors.lastname: Bakhos
mesh_terms: D000925:Anticoagulants / Q000494:pharmacology*; D019540:Area Under Curve; D016568:Drugs, Generic / Q000494:pharmacology*; D017984:Enoxaparin / Q000494:pharmacology*; D006801:Humans
chemical_list: D000925:Anticoagulants; D016568:Drugs, Generic; D017984:Enoxaparin
keywords: anticoagulants; heparins; low-molecular-weight heparins