Comparative studies on biological activity of generic and branded enoxaparin in vivo and vitro.

As per US Food and Drug Administration (FDA) requirement, the study was designed to conduct the fourth and fifth criteria of Abbreviated New Drug Application to demonstrate equivalence of generic and branded Enoxaparin in vivo and vitro.Pharmacodynamic behavior of branded and generic Enoxaparin was compared in a parallel study in rats based upon measurement of anti-FXa and anti-FIIa profiles. Blood samples collected at baseline and at 0.5, 1, 2, 4, 6, 8, 12 and 24 h postsubcutaneous administration of six batches of Lovenox and nine batches of generic Enoxaparin were evaluated for anti-FXa and anti-FIIa using chromogenic substrate method. Anti-FXa, Anti-FIIa, activated partial thromboplastin time (APTT), and Heptest prolongation time were conducted in vitro as per the United States Pharmacopeia method. Pharmacodynamics parameters were obtained including peak effect (anti-FXamax, anti-FIIamax), area under the effect curve (AUEC0-T and AUEC0-∞), Tmax, and T1/2.Pharmacokinetic differences were not observed using anti-FXa or anti-FIIa. No statistically significant differences were observed between branded and generic Enoxaparin either in vitro anti-FXa, anti-FIIa, APTT, or Heptest assay.It can be concluded that they are bioequivalent in anticoagulant activity tested in vivo and vitro.