The EMA workshop on biosimilars was held on 31 October 2013 in London, UK. The workshop was organized as part of EMA’s public consultation exercise on its three draft revised overarching guidelines on biosimilars [1]. The aim of the workshop was to bring together regulators and stakeholders to discuss the three draft revised guidelines, including comments received so far during the public consultation.

EGA believes that the revised overarching biosimilar guidelines, which are at different stages of revision, will further strengthen the pioneering role of the European regulatory and scientific framework for biosimilars.

Mr Karl Heinz Emmert, Head Biosimilar Project Leader at Teva, who spoke on behalf of the European Biosimilars Group (EBG), part of EGA, at the workshop, commended the revision of the guideline on biosimilar medicinal products for its introduction of the use of reference products sourced from highly regulated markets outside of Europe. The revised draft version of this guideline is seen by EBG as an important step toward global development of biosimilars. Mr Emmert concluded that ‘near-term adoption of this guideline will accelerate patient access to effective modern biological therapeutic alternatives.’

EGA estimates the development costs for biosimilars to range from Euros 100 to Euros 250 million, adding that repeating studies could almost double these costs. More importantly, it would be unethical to repeat clinical studies that serve no scientific purpose.

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Reference

1.  GaBI Online - Generics and Biosimilars Initiative. EMA organizes workshop on biosimilars guidelines [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Nov 8]. Available from: www.gabionline.net/Guidelines/EMA-organizes-workshop-on-biosimilars-guidelines

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