First U.S. Biosimilar Can Enter Market Sept. 3; Court Denies Amgen’s Motion To Block Zarxio

The first FDA-approved biosimilar may enter the market as soon as Thursday (Sept. 3) due to a federal appeals court's denial of Amgen’s emergency motion to block Sandoz from marketing its biosimilar Zarxio. The Wednesday morning decision came after Amgen filed a motion last week that would have prevented Sandoz from marketing, selling, offering for sale, or importing to the United States its biosimilar of Amgen’s Neupogen pending Amgen’s appeal for an en banc hearing. The biosimilar sponsor pushed back...