Update: Amgen fails in its bid to block Neupogen biosimilar as Sandoz launches Zarxio in the USA

Swiss pharma giant Novartis’ (NOVN: VX) generics subsidiary Sandoz announced today that Zarxio (filgrastim-sndz) is now available in the USA. Zarxio is the first biosimilar approved by the US Food and Drug Administration (The Pharma Letter March 6) and the first to launch in the USA.

The news comes as Amgen (Nasdaq: AMGN), which makes the reference product Neupogen (filgrastim), lost yet another bid to delay Zarxio from entering the market. The US Court of Appeals for the Federal Circuit denied its request for a temporary ban as the court decides if it should reconsider a previous ruling. This case is expected to give clarity for other drugmakers invested in biosimilars. Zarxio has launched at a 15% discount to Neupogen. A company spokesman said Zarxio, which became the first biosimilar approved by the FDA when it was authorized in March, will have a wholesale acquisition cost of around $275 for a 300 mcg syringe and about $438 for a 480mcg syringe.

Richard Francis, global head of Sandoz, said: "As the pioneer and global leader in biosimilars, Sandoz has maintained a commitment to bringing high-quality biosimilar medicines to patients and healthcare professionals around the world. With the launch of Zarxio, we look forward to increasing patient, prescriber and payer access to filgrastim in the US by offering a high-quality, more affordable version of this important oncology medicine."