The Saga of the Legal Framework for Biogenerics in Europe

Abstract

In 2004, Europe took the lead among regulated markets in creating a legal framework and a regulatory route for biogenerics. The EU has consequently established a competitive advantage over the USA and Japan in this sector. This paper covers the process of drafting and adopting the legal framework for biogenerics in the enlarged EU through the review process of the European pharmaceutical legislation and in parallel with the publication of the new Annex I of Directive 2001/83/EC, which delineates instructions for the presentation and content of the different types of application dossier in Europe. This paper describes the precise chronological order of the development of the legal framework, as well as the main actors in the process, and describes the background to the adoption of the final terminology used to designate biogenerics — that is, ‘similar biological medicinal products’.