Related Experiment Video
Updated: Mar 14, 2026
11:17
Rapid Point-of-Care Assay of Enoxaparin Anticoagulant Efficacy in Whole Blood
Published on: October 12, 2012
14.5K
Update on Brazilian biosimilar enoxaparins
Eduardo Vilanova1, Bianca F Glauser1, Stephan-Nicollas M C G Oliveira1
1a Hospital Universitário Clementino Fraga Filho and Instituto de Bioquímica Médica Leopoldo de Meis , Universidade Federal do Rio de Janeiro (UFRJ) , Rio de Janeiro , Brazil.
Expert Review of Hematology
|September 30, 2016
Summary
Brazilian biosimilar enoxaparins demonstrate comparable quality to the original product. Despite proven efficacy, their high cost limits use in Brazil, favoring unfractionated heparin.
Area of Science:
- Pharmacology and Pharmaceutical Sciences
- Biotechnology and Biosimilars
Background:
- Brazil has approved biosimilar enoxaparins, with research groups conducting quality control assessments.
- Previous assessments have not identified significant differences between biosimilar and original enoxaparins.
Purpose of the Study:
- To evaluate the quality control of biosimilar enoxaparins available in Brazil over the past decade.
- To compare physicochemical properties, disaccharide composition, anticoagulant activity, bioavailability, and safety of biosimilar versus original enoxaparin.
Main Methods:
- Comprehensive quality control assessments including physicochemical analysis.
- Evaluation of disaccharide composition.
- Assays for anticoagulant activity, bioavailability, and safety profiling.
Main Results:
- No noticeable differences were found between Brazilian biosimilar enoxaparins and the original enoxaparin.
- Key quality attributes including physicochemical properties, composition, activity, bioavailability, and safety were comparable.
Conclusions:
- Brazilian biosimilar enoxaparins meet quality standards comparable to the originator product.
- Despite clinical advantages, the high cost of both original and biosimilar enoxaparins contributes to their underuse in Brazil.
- The Brazilian public health system's preference for unfractionated heparin for thromboembolism prophylaxis and treatment is noted.
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