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Updated: May 25, 2026
11:17
Rapid Point-of-Care Assay of Enoxaparin Anticoagulant Efficacy in Whole Blood
Published on: October 12, 2012
Propositional debate on biosimilar enoxaparin in Brazil.
Paulo A S Mourão1, Bianca F Glauser, Bruno C Vairo
1Laboratório de Tecido Conjuntivo, Hospital Universitário Clementino Fraga Filho, Instituto de Bioquímica Médica, Universidade Federal do Rio de Janeiro, Brazil. pmourao@hucff.ufrj.br
Arquivos Brasileiros De Cardiologia
|February 11, 2012
Summary
Biosimilar low-molecular-weight heparins (LMWHs) like enoxaparin are therapeutically similar to original drugs. These biosimilar LMWHs offer a valid alternative, though regulatory oversight is needed.
Area of Science:
- Pharmacology
- Biochemistry
Background:
- Patent expirations for low-molecular-weight heparins (LMWHs) have led to the availability of biosimilar versions.
- Skepticism exists regarding the similarity of biosimilar LMWHs to original drugs due to complex manufacturing.
Purpose of the Study:
- To assess the similarity of biosimilar enoxaparin preparations to the original drug.
- To evaluate the therapeutic validity of biosimilar enoxaparin available in Brazil.
Main Methods:
- Analysis of 30 batches and 70 finished products of biosimilar enoxaparin.
- Assessment of chemical structure, molecular weight distribution, in vitro anticoagulant activity.
- Evaluation of pharmacological effects in animal models for thrombosis and bleeding.
Main Results:
- Biosimilar enoxaparin preparations demonstrated similarity to the original enoxaparin drug.
- No significant differences were observed in chemical structure, molecular weight, or biological activity.
Conclusions:
- Biosimilar enoxaparin is a valid therapeutic alternative to the original drug.
- Appropriate regulation is necessary to ensure biosimilar LMWH products meet quality standards.
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