Amgen, Novartis hematology, biosimilars news
The U.S. Court of Appeals for the Federal Circuit (CAFC) denied Amgen’s attempt to further delay the launch of Zarxio filgrastim-sndz from Novartis’ Sandoz unit. The court did not provide a reason for its decision. Subsequently, Sandoz launched Zarxio, which FDA approved on March 6, at a 15% discount to its reference drug, Amgen’s Neupogen filgrastim methionyl human G-CSF. Zarxio is the first biosimilar approved and marketed in the U.S. Novartis said Zarxio’s wholesale acquisition cost (WAC) is $275.66 for a 300 ug/0.5 mL dose and $438.98 for a 480 ug/0.8 mL dose. The WAC for equivalent doses of Neupogen is $324.30 and $516.45, respectively. Last month, Amgen filed an emergency motion with the CAFC for an injunction to further delay the launch pending a potential en banc review of the case. ...