The United States Supreme Court on Monday ruled against Amgen’s bid to delay its biosimilar rivals’ 180-day marketing notices until after the U.S. Food and Drug Administration (FDA) resolved the marketing application.
Although the ruling dealt a blow to Amgen, the company had recently tasted victory when the FDA shut down rival Coherus’ Neulasta biosimilar application. Amgen will be rival-free on the frant until at least 2018.
Justices’ ruling did, however, hand off a win to Sandoz, a Novartis generics unit. Sandoz is in the midst of launching a generic Neupogen drug which was originally developed by Amgen.