How Should Synthetic Follow-Ons of Biological Products Be Regulated? What Are the Implications for Automatic Substitution?

Abstract

Follow-on products referencing biological medicines have from 2005 until recently been licensed as biosimilars in the European Union (EU), because they have themselves been biological medicines. However, synthetically produced follow-on products referencing biological medicines are now emerging. This presentation will address the EU regulatory and scientific challenges associated with these products – primarily with respect to licensing, but also in relation to allowing automatic substitution at the pharmacy level.