The FDA has accepted for review an application submitted by Mylan N.V. (“Mylan”) and Biocon Ltd. (“Biocon”) under the 351(k) pathway for MYL-1401K, a proposed biosimilar to Amgen’s Neulasta® (pegfilgrastim).  According to the announcement, the BSUFA date (FDA’s target goal) for a decision on the application is October 9, 2017.

The FDA has not