Blog Big Molecule Watch October 12, 2017

EMA Accepts Application for Cinfa’s Pegfilgrastim Biosimilar

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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