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FDA to review Mylan's marketing application for Neulasta biosimilar; shares up a fraction premarket

Feb. 16, 2017 9:14 AM ETViatris Inc. (VTRS) StockBy: Douglas W. House, SA News Editor2 Comments
  • The FDA accepts for review Mylan's (MYL) Biologics License Application (BLA) seeking approval of a biosimilar to Amgen's (AMGN) Neulasta (pegfilgrastim). The agency's action (PDUFA) date is October 9.
  • Mylan developed the product in collaboration with India-based Biocon Ltd. (OTC:BCNQY).

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