Novartis has launched the first biosimilar in the US after an appeals court failed to back Amgen's bid to block the copycat version of its blockbuster white blood cell stimulator Neupogen.
Amgen was seeking a temporary injunction to delay the launch of Zarxio (filgrastim-sndz) by Novartis’ unit Sandoz until an ongoing patent dispute between the firms is settled, but this was rejected by the US Court of Appeals for the Federal Circuit.
Zarxio became the first biosimilar approved by the US Food and Drug Administration in March this year, for the same indications as Neupogen (filgrastim), and is now also the first launched in the country.
The US wholesale list price for the 300mcg syringe of Zarxio is $275.66, and the 480mcg $438.98, a 15% discount to Neupogen’s costs at $324.30 and $516.45, respectively, according to Reuters.
EU filing for etelcalcetide
Meanwhile, the US biotech said it has submitted an application in Europe to market etelcalcetide (formerly AMG 416) for the treatment of secondary hyperparathyroidism in adult patients with chronic kidney disease on haemodialysis therapy.
If approved, etelcalcetide will be the first calcimimetic agent that can be administered intravenously, at the end of dialysis sessions.
The drug binds to and activates the calcium-sensing receptor on the parathyroid gland, thereby decreasing parathyroid hormone levels.