Key result
Generic low-molecular-weight heparins present controversies regarding therapeutic and generic interchangeability, prompting specific recommendations for their regulatory approval process.
This commentary provides recommendations for regulatory bodies regarding the approval process and interchangeability of generic low-molecular-weight heparins.
May warrant caution with generic LMWH interchange in practice; leaves open harmonized regulatory criteria for bioequivalence.
This commentary briefly reviews the controversies of therapeutic and generic interchangeability, as they apply to the antithrombotic drug class called low-molecular-weight heparin (LMWH). Recommendations are prepared for the generic LMWH approval process by various regulatory bodies.
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Leong et al. (2003) studied this question. Generic low-molecular-weight heparins present controversies regarding therapeutic and generic interchangeability, prompting specific recommendations for their regulatory approval process.
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