EMA Accepts Application for Cinfa’s Pegfilgrastim Biosimilar

BioSimilars Patent Dance

BioSimilars Patent DanceLast 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®.