Non-clinical and clinical development of similar biological medicinal products containing low-molecular-weight heparins

This document 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.

Keywords: Low molecular weight heparins, low molecular mass heparins, similar biological medicinal products, biosimilar, comparability, quality, non-clinical studies, clinical studies, extrapolationocument history