EMA: Concept paper on the revision of the guideline on nonclinical and clinical development of similar biological medicinal products containing low-molecular-weight heparins

The Guideline on Similar Medicinal Products containing Low-Molecular-Weight Heparins (LMWH) lays down the non-clinical and clinical requirements for the development of LMWH claimed to be similar to a reference product already authorised in the EU. This guideline came into effect in October 2009. So far, no biosimilar LMWH has been licensed in the EU.