EMA consults on draft guideline for biosimilars containing low-molecular-weight heparins

The European Medicines Agency has launched a six-month public consultation on the revised guideline on non-clinical and clinical development of similar biological medicinal products containing low-molecular-weight heparins (LMWHs).

LMWHs, which are fragments of heparin, display anticoagulant activity and are indicated for various conditions, including the treatment and prophylaxis of deep venous thrombosis and the prevention of complications of acute coronary syndromes. Prepared from animal tissues, LMWHs have a high level of heterogeneity and the structure-effect relationship is still not fully elucidated.

This guideline describes the non-clinical and clinical requirements for a LMWH-containing medicinal product claiming to be similar to another one already on the market. The non-clinical section addresses the pharmacotoxicological requirements and the clinical section describes the requirements for pharmacokinetic, pharmacodynamic, efficacy and safety studies as well as pharmacovigilance aspects.