FDA to review Mylan, Biocon’s biosimilar to Amgen’s cancer treatment Neulasta, announcing competition to slightly decreasing market
The U.S. Food and Drug Administration (FDA) has accepted Mylan’s Biologics License Application (BLA) for multiple types of cancer treatment MYL-1401H, a proposed biosimilar to Amgen’s Neulasta. This is the second BLA accepted for review by FDA as part of the Mylan and Biocon partnership within the past two months.