EMA Releases Long-Awaited Guidelines For Biosimilar Antibodies
Mondaq Business Briefing › United States Law Articles in English (2011)
Linked as:
Extract
EMA Releases Long-Awaited Guidelines For Biosimilar Antibodies
On November 26, 2010, the European Medicines Agency released its proposed guideline for regulatory approval of similar biological medicinal products containing monoclonal antibodies ("Guideline"). Although the EMA has had a framework for approving biosimilar medicines for several years, and has approved over a dozen biosimilar products, to date it has not approved any biosimilar antibodies. The long-awaited Guideline sets forth the non-clinical and clinical requirements for monoclonal a...
See the full content of this document
Sponsored links
