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 yet approved a pegfilgrastim biosimilar but there are several applications under review, including applications from at least Apotex (accepted by FDA in December 2014), Sandoz (accepted by FDA in November 2015) and Coherus (accepted by FDA in October 2016).