Appeals Court Refuses to Rehear Zarxio Case

October 22, 2015

A federal appeals court refused to rehear the biosimilars case pitting Sandoz against Amgen, letting stand a July decision allowing Sandoz to launch its Zarxio biosimilar of Amgen’s cancer therapy Neupogen (filgrastim) in September.

In a two-page order, the U.S. Court of Appeals for the Federal Circuit denied petitions from both companies. Amgen had claimed that the court erred when it found biosimilars makers are not compelled to disclose relevant patent information to the reference product maker.

The July ruling was not a complete win for Sandoz, as the court ruled biosimilar makers must have FDA approval of their product before giving the reference product manufacturer 180-day notice of first commercial marketing of the knock off. Sandoz had argued that the clock should have started ticking when it gave Amgen notice of its intent to market Zarxio in July 2014. Sandoz notified Amgen a second time on March 6 when it received FDA approval, clearing Zarxio for launch after Sept. 2.

Sandoz began marketing Zarxio on Sept. 3, offering a 15 percent discount over Neupogen, after a three-judge panel refused Amgen’s eleventh hour request for a preliminary injunction and a full court review of the July decision.

The contest may not be over yet. Sandoz saidit is considering its options, while Amgen said it doesn’t comment on ongoing litigation. — John Bechtel