EGA Press Release

Wednesday, 21 November 2007

PUBLIC INFORMATION LAUNCHED ON BIOSIMILAR MEDICINES

The European Generic medicines Association (EGA) launched its handbook on biosimilar medicines today in Brussels at an event featuring healthcare stakeholders and representatives from the pharmaceutical industry. In his opening speech, EGA President Eric Gorka said that this guide to the public has been designed as an important reference source for all those— patients, healthcare professionals, legislators, policy makers — who need to understand what these new medicines are, why they are becoming more important, what benefits they bring, and what questions their introduction has raised.

The importance of biosimilar medicines for today’s Europe is clearly increasing. After the approval by the European Commission of five biosimilar medicines and the issuing of two positive scientific opinions, the EMEA announced in October that eight new applications for approval of biosimilar medicines have been received this year, and a further eight are expected by the end of the year. That means that roughly 30% of all centralised applications received and expected in 2007 will be for these new types of medicines.

Dr Sandy Eisen, Chair of the EGA Committee on Biotechnology and Biosimilar Medicines, highlighted the emphasis the new handbook places on describing the science and technology involved in developing and producing biosimilar medicines, and on addressing such issues as comparability, pharmacovigilance, traceability, interchangeability and substitution.

Just as conventional generic medicines currently save the EU an estimated €20 billion each year, competition from biosimilar medicines resulting in only a 20% reduction on five off-patent biopharmaceutical medicines could save the EU over €1.6 billion annually.

Biopharmaceuticals can be produced by manufacturers other than the originator as ‘biosimilar medicines’ once the relevant patents have expired. To gain approval for use from the European Commission, biosimilar medicines must demonstrate that they are as safe and effective as the originator reference product. Their potency and purity must also not vary outside the limits displayed by the reference product. To meet these stringent standards of quality, safety and efficacy, the biosimilar development process uses the very latest analytical and clinical technologies, including some that may not have been available when the reference product was first approved.

The existence of a regulatory pathway in the European Union and the subsequent number of applications has made Europe the global centre for the development and production of biosimilar medicines. As Commissioner Verheugen said upon the approval of the first biosimilar medicine in April 2006, “Biosimilar medicines offer new opportunities, both for the growth of our generic industry and for the control of national healthcare expenditure.”

A copy of the handbook is available by e-mail from the . Please include your name, company/organisation and position with your request.

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