EGA Press Release

Thursday, 24 April 2008

BIOSIMILAR MEDICINES – DEVELOPING MARKET PATHWAYS
THAT BENEFIT PATIENTS IS A SHARED RESPONSIBILITY

In his opening address to the 6th EGA Symposium on Biosimilar Medicines today in London, EGA Director General Greg Perry congratulated the industry and EU medicines regulatory authorities for further consolidating and developing EU “biosimilar thinking” during 2007. “This rigorous scientific approach”, Mr Perry said, “has firmly established the EU as the world leader in biosimilar medicines.” With 10 new applications each, biosimilar and generic medicines made up 22% of all applications received by the EMEA under the centralised procedure in 2007. These numbers are expected to increase during 2008. 2007 also saw another important breakthrough for the biosimilar medicines industry when biosimilar epoetin products were granted market approval and biosimilar filgrastim products received positive scientific opinions from the EMEA.

But the important question, Mr Perry explained, is how quickly now can Europe’s patients benefit from the EU’s lead in biosimilar medicines? The key to ensuring rapid access to these important more affordable therapies lies in developing appropriate market pathways. Doing this means reinforcing confidence of patients and healthcare professionals in the EU approval process of biosimilar products by informing all stakeholders more widely that biosimilar medicines are manufactured to the same quality standards (GMP) as other current biopharmaceuticals, that therapeutic equivalence with the reference biopharmaceutical is proven scientifically, that clinical efficacy and safety are demonstrated in clinical studies, and that the monitoring of such products is the same as for any other new biopharmaceutical. In addition, Mr Perry, said, the use of scare tactics against biosimilar medicines must cease. This has included misrepresenting an event recently organised in the UK Parliament by the originator industry as a formal Parliamentary review. These tactics, said Perry, can only serve to deny patients access to the medicines they need.

For the sake of Europe’s patients, we must all work together, Mr Perry said, to stimulate a genuine breakthrough for biosimilar medicines. This effort, in the opinion of the EGA, should include active support by EU and national authorities of the EU’s unique “Biosimilar Philosophy”; fine-tuning of the EU pharmacovigilance framework; and establishing pricing & reimbursement structures that encourage the market entry of biosimilar medicines and the price competition they provide.

On this last point, Mr Perry insisted it is important to foster the competitiveness of this new sector by promoting a strong, home-based European biosimilar medicines industry, and by striving to reduce their high R&D and manufacturing costs to ensure the lowest possible prices for patients.

In conclusion, Mr Perry launched a call to discuss the “Global Biosimilar Development” concept, as well as how the “Biosimilar Philosophy” can be promoted and exported worldwide as a genuinely EU brand.

Mr Perry concluded his remarks by underscoring that ensuring an increase in access to these important new therapies to greater numbers of patients is a shared responsibility that must be taken up proactively by the industry, the medicines authorities, and healthcare professionals throughout Europe.

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