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Mylan Pharmaceuticals › License Applications

Goodwin

FDA Accepts Mylan aBLA or Pegfilgrastim Biosimilar

Goodwin on

Mylan N.V. and Biocon Ltd. have announced that the FDA has accepted Mylan’s Biologics License Application (BLA) for MYL-1401H, a proposed biosimilar to Amgen’s Neulasta® (pegfilgrastim), for filing through the 351(k)...more

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