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Pharmacodynamic differences between biosimilar and branded enoxaparins with reference to their immunogenic profile
Author(s) -
Ramacciotti Eduardo,
Rao Gundu,
Hoppensteadt Debra,
Jeske Walter,
Fareed Jawed,
Walenga Jeanine M.
Publication year - 2010
Publication title -
the faseb journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.709
H-Index - 277
eISSN - 1530-6860
pISSN - 0892-6638
DOI - 10.1096/fasebj.24.1_supplement.lb490
Subject(s) - depolymerization , pharmacodynamics , antibody , heparin , low molecular weight heparin , pharmacology , titer , anticoagulant , biosimilar , antibody titer , chemistry , pharmacokinetics , medicine , immunology , biochemistry , organic chemistry
Low molecular weight heparins are complex mixtures of sulfated oligosaccharides produced by depolymerization of porcine mucosal heparin. The depolymerization process inflicts a variety of structural modifications which are process‐dependent. The objective of this study was to compare branded enoxaparin (Lovenox, Sanofi‐Aventis) with Cutenox (Gland Pharma) in healthy human volunteers for pharmacodynamic equivalence. Individual groups of volunteers (n=110) were administered test agent at doses of 40 mg OD SC for 10 days and blood samples were collected at baseline and after 1, 3, 7, 10 and 14 days. Hemostatic parameters such as aPTT, anti‐Xa, anti‐IIa and TFPI release were measured. In addition, anti‐heparin‐PF4 antibodies were measured using two commercially available assays (GTI and Hyphen Biomedical). The antibody subtype (IgG, IgA, IgM) was determined using an assay from Hyphen Biomedical. No significant differences in the various hemostatic parameters were noted. The prevalence of positive antibody titers was different between assays, but not between treatment groups. The titer of anti‐heparin‐PF4 IgG antibodies was higher following Cutenox treatment (0.37 ± 0.21) compared to following Lovenox treatment (0.21 ± 0.11). The relative proportion of IgG positive samples was also different in the two groups. These studies suggest that Cutenox produces a different immunogenic profile than Lovenox.