четверг, 16 февраля 2017 г.

FDA Accepts Mylan aBLA or Pegfilgrastim Biosimilar

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