Global framework for biosimilars “is now crucial”

April 26, 2012 8:43 AM

“The need for a framework which allows global biosimilars development is now crucial” announced EGA President Gudbjorg Edda Eggertsdottir in her opening address at the 10th EGA International Symposium on Biosimilars.

European Generic Association’s International Symposium on Biosimilars was held in London, UK last week. During her opening speech, the President of EGA and Iceland&EVP Special Projects at Actavis, stated that a global framework is needed for the industry.

Taking the critical example of the huge increase in diabetes in the coming years, EGA’s President highlighted that the access to affordable biosimilar insulin will be key for treating millions of patients worldwide. “Biosimilars will also promote significant cost savings that help to safeguard the sustainability of European and indeed global healthcare systems while ensuring access to high standard treatment for patients” Ms Eggertsdottir said.

Governments, however, will not be able to benefit from biosimilars if a framework for development programmes is not established. A Global Biosimilar Development Programme is critical, said Ms Eggertsdottir, which would consist of a two-pronged approach:

• Continuous dialogue on EU/US negotiations regarding the acceptance of scientific bridging studies and
• Revising the EU so-called “over-arching” biosimilars guideline.

European companies should also be allowed to manufacture biosimilars in Europe during the patent/SPC period for export to countries where no patent exists or has expired. Moreover, research funding and tax breaks for clinical trials should also apply to biosimilar developments.

Crucially, though, Europe itself needs an improved attitude towards biosimilars in the EU. The EGA therefore strongly supports DG Enterprise’s Project Group on Market Access and Uptake of Biosimilars. The aim is to identify obstacles and good practices in Member States, whilst providing accurate and unbiased information to counterbalance continuous misinformation and misperceptions regarding biosimilars.

“If we want a sustainable biosimilar medicines industry, we have to be careful to protect this industry in its infancy. Therefore policy makers need to use all avenues possible to increase the competitiveness of the European biosimilar industry and not only focus on using biosimilars as a means of reducing the price of originator products” EGA’s President concluded.


Source: EGA press release

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