FDA adopts European approach to biosimilars
The Food and Drug Administration has shed some light on its approach to assessing biosimilars in a recent article published in the New England Journal of Medicine
The agency said it will take a so-called totality of the evidence approach to making regulatory decisions on biologic drugs. This approach was influenced in part by the European Medicines Agency (EMA), which approved its first biologic drug in 2006.
Please log in
to read the rest of this article. New to Managing Intellectual Property?
Take advantage of free access to up to 5 articles on Managing IP and become a member today. It’s free to join and the benefits start straight away.
Please make sure you log in to read the rest of the article.
Join us nowGain FREE access to up to five free articles when you register now.