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) pathway. Mylan stated that the FDA goal date set under the Biosimilar User Fee Act (BsUFA) is Oct. 9, 2017.
At least Coherus, Sandoz, and Apotex have all previously announced FDA acceptance of their BLAs for proposed pegfilgrastim biosimilars. Amgen is currently appealing a district court determination that Apotex does not infringe one of Amgen’s pegfilgrastim-related patents.
