Posted by Michael Wonder on 16 Feb 2017
U.S. FDA accepts biologics license application for Mylan and Biocon's proposed biosimilar pegfilgrastim for review
16 February 2017 - Second successful BLA filing of the partnership in the U.S.
Mylan and Biocon today announced that the U.S. FDA has accepted Mylan's Biologics License Application (BLA) for MYL-1401H, a proposed biosimilar to Neulasta (pegfilgrastim), for filing through the 351(k) pathway.
The FDA goal date set under the Biosimilar User Fee Act is 9 October 2017.
