Key result
Generic LMWH production guidelines require harmonization to ensure product quality and patient safety.
Why the study?
Differences exist between current recommendations and guidelines for the production of generic low-molecular-weight heparins, raising concerns about safety and quality.
There is a need to harmonize guidelines for the production of generic low-molecular-weight heparins to ensure product quality and patient safety.
Generic enoxaparin approval may expand access; leaves open rigorous equivalence and safety data in broad populations.
Based on the results of large clinical trials, several low-molecular-weight heparins (LMWHs) have been approved for prophylaxis and the treatment of venous and arterial thromboembolism. As a result of expiration or pending expiration of patent protection of the originator LMWHs, the first generic LMWH enoxaparin has been approved by the Food and Drug Administration for clinical use in all medical indications. The European Medicines Agency has set up guidelines for the production of generic LMWHs. The International Society of Thrombosis, the North American Thrombosis Forum and other scientific organizations raised concerns regarding the safety of generic LMWHs due to economic reasons. These organizations have published statements for the production of generic LMWHs to ensure the quality of the products and the safety for patients. Ideally, the differences between the actual recommendations and guidelines for the production of generic version of LMWHs should be harmonized.
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Job Harenberg (2011) conducted a review in Venous and arterial thromboembolism. Generic low-molecular-weight heparins was evaluated. Differences between current recommendations and guidelines for the production of generic low-molecular-weight heparins should be harmonized to ensure product quality and patient safety.
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