Sandoz Urges Federal Circuit to Dismiss Amgen’s Effort to Block Neupogen Biosimilar

As Zarxio’s Sept. 3 launch neared, Sandoz was urging the Federal Circuit to dismiss Amgen’s last-ditch effort to block the Neupogen biosimilar, saying the brandmaker’s request for an emergency injunction doesn’t meet the required standard.

Amgen filed the injunction in Amgen Inc. et al. v. Sandoz Inc. in late August, asking that Zarxio (filgrastim-sndz) be delayed pending a response to an earlier request seeking full court review of a three-judge panel’s July ruling, which cleared the way for this week’s launch.

Amgen argued that the panel erred by declaring that biosimilars makers aren’t compelled to disclose relevant patent information to the reference product maker.

In its response, Sandoz claims it should be allowed to begin marketing its product on Sept. 3 because Amgen is unlikely to succeed on the merits of its petition, and hasn’t shown it will suffer irreparable harm by the introduction of the Neupogen (filgrastim) biosimilar. — John Bechtel