EMEA: Adopted guideline on similar biological medicinal products containing low-molecular-weight-heparins

This guideline lays down the non-clinical and clinical requirements for low molecular weight heparins (LMWHs, low molecular mass heparins, LMMH) containing medicinal products claiming to be similar to another one already marketed. The non-clinical section addresses the pharmaco-toxicological requirements and the clinical section the requirements for pharmacokinetic, pharmacodynamic, efficacy and safety studies as well as pharmacovigilance aspects.