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Recommendations on biosimilar low-molecular-weight heparins
J Harenberg1, A Kakkar, D Bergqvist
1Clinical Pharmacology, Faculty of Medicine Mannheim, Ruprecht-Karls University Heidelberg, Mannheim, Germany. job.harenberg@medma.uni-heidelberg.de
Journal of Thrombosis and Haemostasis : JTH
|March 28, 2009
Summary
Generic low-molecular-weight heparins (LMWHs) offer cost savings for preventing and treating blood clots. International guidelines now recommend standards to ensure the quality of these biosimilar LMWHs compared to original treatments.
Area of Science:
- Pharmacology and Therapeutics
- Hematology
- Biotechnology
Background:
- Several low-molecular-weight heparins (LMWHs) are approved for preventing and treating thromboembolism.
- Patent expirations are leading to the approval of generic and biosimilar LMWHs.
- Increased availability of biosimilar LMWHs may reduce healthcare costs.
Purpose of the Study:
- To establish recommendations for developing biosimilar LMWHs.
- To ensure the quality of biosimilar LMWHs is comparable to originator products.
- To provide guidance for the Subcommittee on Control of Anticoagulation.
Main Methods:
- Consensus reached by the Working Party on Requirements for Development of Biosimilar LMWHs.
- Recommendations based on analysis of large clinical trials and quality standards.
- Focus on comparability between biosimilar and originator LMWHs.
Main Results:
- A consensus on recommendations for biosimilar LMWH development has been achieved.
- These recommendations aim to guarantee the quality and efficacy of biosimilar LMWHs.
- The guidelines address the critical aspects of biosimilar LMWH characterization and control.
Conclusions:
- The established recommendations will facilitate the development and approval of high-quality biosimilar LMWHs.
- Ensuring comparability to originator LMWHs is crucial for patient safety and therapeutic equivalence.
- These guidelines support the broader availability of LMWH treatments at potentially lower costs.
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