EGA strongly supports EMA position on biosimilar labelling

December 4, 2014 9:25 AM

During the DIA Biosimilars Conference 2014 in Berlin, Elke Grooten, Director Public Affairs Sandoz Europe and Member of the EGA-European Biosimilars Group, welcomed the opportunity to present the EBG position statement on labelling for biosimilar medicines.

Ms. Grooten expressed full support for the European Medicines Agency (EMA) approach on biosimilar labelling which requires the label of the biosimilar product, which describes its medical use, to be consistent with the label of the reference product.

In her presentation, Grooten stressed that the system of product information for biosimilar medicines in place since 2006, is adequate, reliable, safe and transparent and that it enables prescribers and patients to safely and effectively use biosimilar medecines.

This labelling model is in line with the scientific principles of biosimilarity and the EU legal requirements and ensures that all the key information is available to patients and healthcare professionals.

“Any deviations in a biosimilar’s product information compared to the reference product´s product information could create unnecessary confusion” she explained.  “This could mislead healthcare professionals and patients and create a situation where biosimilar products are no longer considered as therapeutic alternatives to their reference products”.  Changes would also further deepen the misunderstanding and misinterpretation of the biosimilarity concept, she added.

“It is therefore imperative that we maintain consistent labels for the reference product and biosimilar medicines”, Grooten concluded.

“The EU labelling system is important to maintain trust in the pioneering European authorisation system for biosimilar medicines commented Adrian van den Hoven, EGA Director General. “This proven model should not be dismantled now to create artificial distinctions between reference and biosimilar products”, he warned.

Source: EGA press release

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