Europe issues biosimilar-friendly guidelines
Guidelines for the production of biosimilar antibody drugs in Europe released last week focused on safety rather than efficacy, setting a lower hurdle than had been feared
European Medicines Agency’s rules will require
generic producers of antibody drugs to prove that their product
is as effective and safe as the reference product.
They will not have to prove separately that the drug
benefits users, as...
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.