![FDA, FTC and DOJ Enforcement of Medical Device Regulations FDA, FTC and DOJ Enforcement of Medical Device Regulations](https://www.fdanews.com/ext/resources/Book-Covers-2/BFFDEMDR-COVER.png?height=200&t=1685733565&width=200)
Home » EMEA Gives Biosimilars Manufacturers Development Recommendations
EMEA Gives Biosimilars Manufacturers Development Recommendations
May 21, 2009
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
International Pharmaceutical Regulatory Monitor
Upcoming Events
-
21Oct