A comparison of the pharmacodynamic behavior of branded and biosimilar enoxaparin in primates. Journal Article

Authors: Jeske, W; Litinas, E.; Khan, H.; Hoppensteadt, D; Fareed, J
Article Title: A comparison of the pharmacodynamic behavior of branded and biosimilar enoxaparin in primates.
Abstract: Pharmacodynamic behavior of branded and biosimilar enoxaparin was compared in a crossover study in primates. Blood samples collected at baseline and at 1, 4, 6, and 28 hours post-subcutaneous administration of Lovenox or Fibrinox were evaluated using clot-based and amidolytic assays. Anti-Xa levels following Fibrinox and Lovenox administration were not different. Anti-IIa levels were significantly higher in Lovenox-treated animals 1 to 6 hours post-administration. Higher drug levels were measured by Heptest in Fibrinox-treated animals from 4 to 6 hours. Pharmacokinetic differences were not observed using anti-Xa or Heptest assays. The area under the curve (anti-IIa) following Lovenox treatment was significantly larger than following Fibrinox treatment. When drug levels (anti-IIa) were plotted against anti-Xa or Heptest drug levels, a hysteretic relationship which was distinct for Fibrinox- and Lovenox-treated primates was observed suggesting a lack of bioequivalence for the low-molecular-weight heparin tested. In vivo behavior is an important consideration for defining pharmacoequivalence of complex biologic drugs.
Journal Title: Clinical Applied Thrombosis/Hemostasis
Volume: 18
Issue: 3
ISSN: 1938-2723
Publisher: Unknown  
Journal Place: United States
Date Published: 2012
Start Page: 294
End Page: 298
Language: English
Notes: ID: 12533; Record Owner: From MEDLINE, a database of the U.S. National Library of Medicine.; Status: MEDLINE; Publishing Model: Journal available in: Print-Electronic Citation processed from: Internet; NLM Journal Code: dav, 9508125; CAS Registry/EC Number/Name of Substance: 0 (Anticoagulants). 0 (Blood Coagulation Factor Inhibitors). 0 (Drugs, Generic). 0 (Enoxaparin).; Electronic Date of Publication: 20120123; Entry Date: 20120904