EMA Accepts Mylan and Biocon’s Application for Authorization to Market a Pegfilgrastim Biosimilar

EMA News

Mylan N.V. and Biocon Ltd. recently announced that the European Medicines Agency has accepted Mylan’s Marketing Authorization Application for a proposed biosimilar version of Amgen’s Neulasta (pegfilgrastim). In Europe, Neulasta is indicated for the treatment of certain side effects associated with cytotoxic chemotherapy, including neutropenia.  According to the two companies, the proposed biosimilar resulted from a joint development project of Mylan and India-based Biocon.  The EMA has previously accepted an MAA for a pegfilgrastim biosimilar from Sandoz.

Stay tuned to Big Molecule Watch for further developments.

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