EMA Accepts Application for Cinfa’s Pegfilgrastim Biosimilar

EMA News

Last week, Cinfa Biotech S.L. announced that the European Medicines Agency (EMA) has accepted its application to market a molecule referred to as B12019, a biosimilar of Amgen’s Neulasta® (pegfilgrastim), for the treatment of chemotherapy-induced neutropenia.  To support its application, Cinfa conducted two studies confirming the analytical and biofunctional similarity of B12019 and Neulasta®.

 

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