EMEA Gives Biosimilars Manufacturers Development Recommendations

Companies that plan to make biosimilar drugs to compete with Sanofi-Aventis’ blockbuster blood-clot treatment Lovenox have received a European Medicines Agency (EMEA) guideline for products containing low-molecular-weight heparins (LMWHs). The guideline was adopted last month by the agency’s Committee for Medicinal Products for Human Use. It outlines nonclinical and clinical recommendations for developing LMWH products similar to Lovenox (enoxaparin sodium).
International Pharmaceutical Regulatory Monitor