The EU Regulatory Environment for ‘Biosimilars’: Today's Picture and Future Prospects

Times are changing in biotechnology. With the expiration of patent protection for some of the most profitable biologics in the next few years, a new, fast-growing field has started to emerge: ‘biogenerics’. Known as ‘similar biological medicinal products’ or ‘biosimilars’ in Europe, these products are about to enter the now-enlarged Community market. A number of uncertainties and challenges still lie ahead, though. To regulate biosimilars means dealing with complex molecules, which are tricky to characterise and highly sensitive to manufacturing changes, to which a ‘classical’ generics approach is not directly applicable. Specific legislation needs to be put in place. While hearings regarding the need for special regulation on ‘biogenerics’ are now being held in the USA, European regulatory authorities have taken the lead by establishing a tailor-made legal framework for biosimilars with the publication of the so-called ‘Annex I’, in 2003. Further developments are expected with the revision of the EU pharmaceutical legislation (the Pharma Review), which was adopted by European institutions in 2004. The purpose of this article is to provide an overview of this framework, the main consequences of the Pharma Review and a discussion on key points to be considered when entering this emerging market.