EGA requests EMA to adopt revised biosimilars guideline rapidly

November 1, 2013 10:24 AM

Yesterday EMA, Europe’s watchdog issued a whole day workshop about biosimilars and right after that workshop, EGA issued a press release as below:

The EGA congratulates the European Medicines Agency and its Biosimilar Medicines Working Party for organising a multi-stakeholder workshop to discuss the overarching biosimilar guidelines which are at different stages of revision. The revised guidelines will further strengthen the pioneering role of the European regulatory and scientific framework for biosimilar medicines. Karl Heinz Emmert, Head Biosimilar Project Leader at Teva, on behalf of the European Biosimilars Group (EBG), Sector Group of the EGA, commended the revision of the guideline on biosimilar medicinal products. It contains strong scientific principles to support the use of representative reference products sourced from highly regulated markets outside the European Economic Area. The EBG considers the revised draft version of this guideline as an important step forward in supporting continued development of biosimilar products at global level. “A near-term adoption of this guideline will accelerate patient access to effective modern biological therapeutic alternatives”, he concluded.

Biosimilar development costs are estimated to range from € 100 to € 250 million. The requirement to repeat studies would increase almost double the development cost adding € 100 to € 150 million due to the costs of purchasing the reference product. More importantly, it would be unethical to repeat clinical studies that serve no scientific purpose. “The EGA is ready to work with the EU to rapidly introduce the new regulatory framework which will be crucial for the development of the biosimilar medicines industry and to bring healthy competition to the biopharmaceutical market in Europe”, commented Adrian van den Hoven, EGA Director General.


Source: EGA press release

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