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

Abstract

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.

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References

Communication from the Commission to the Council, the European Parliament, the Economic And Social Committee and the Committee of the Regions (2003) ‘A stronger European-based pharmaceutical industry for the benefit of the patient — A call for action’, COM(2003) 383. Available at http://europa.eu.int/eur-lex/en/com/cnc/2003/com2003_0383en01.pdf.

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Source: Datamonitor; calculation based on sales figures in year 2001.

Commission Directive 2003/63/EC of 25th June, 2003, amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use, Official Journal of the European Union L 159, 27/6/2003 P. 0046–0094.

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Directive 2004/28/EC of the European Parliament and of the Council of 31st March, 2004, amending Directive 2001/82/EC on the Community code relating to veterinary medicinal products, Official Journal of the European Union L 136, 30.4.2004 P. 0058–0084.

Regulation (EC) No. 726/2004 of the European Parliament and of the Council of 31st March, 2004, laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, Official Journal of the European Union L 136, 30.4.2004 P. 0001–0033.

See Annex I, Part II, section 4 of Commission Directive 2003/63/EC of 25th June, 2003, amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use, Official Journal of the European Union L 159, 27/6/2003. P. 0046–0094.

See ‘Guideline on comparability of medicinal products containing biotechnology-derived proteins as active substance — Quality issues’ (EMEA/CPMP/BWP/3207/00); and ‘Guideline on comparability of medicinal products containing biotechnology-derived proteins as drug substance — non clinical and clinical issues’ (EMEA/CPMP/3097/02). Available at http://www.emea.eu.int/.