FDA Accepts Mylan aBLA or Pegfilgrastim Biosimilar


Mylan N.V. and Biocon Ltd. have announced that the FDA has accepted Mylan's Biologics License Application for MYL-1401H, a proposed biosimilar to Amgen's Neulasta , for filing through the 351 pathway. Mylan stated that the FDA goal date set under the Biosimilar User Fee Act is Oct. 9, 2017.



from Biotech News