Amgen Asks Federal Circuit to Stop Sandoz Launch of Zarxio Biosimilar

Amgen made a last-ditch effort to block competition for its chemotherapy product Neupogen, asking the Federal Circuit to stop Sandoz’s launch of its Zarxio biosimilar.

Amgen has asked the court to review its July 21 ruling — specifically a three-judge panel’s determination that biosimilars makers aren’t obligated to share information in their aBLAs with the reference product maker. The Federal Circuit has yet to act on that request, and Amgen wants Zarxio’s (filgrastim-sndz) launch to wait until a call is made.

In its emergency motion, filed Wednesday in Amgen Inc. et al. v. Sandoz Inc., Amgen argues that the panel erred when it held that manufacturers of reference biologicals and the courts can’t compel biosimilars makers to disclose relevant patent information, and seeks a review of the decision that the proper remedy for noncompliance is litigation.

Sandoz file its response earlier this week. In a letter to the court dated last Thursday, the company argues that no further injunction is warranted, and any “emergency” is entirely of Amgen’s own making.

The appellate court decided more than a month ago to extend the injunction. Yet, Amgen waited until days before Sept. 2 to request an extension, says Sandoz attorney Deanne Maynard of Morrison & Foerster. Neupogen (filgrastim) raked in $191 million in sales in the U.S. during the three months ending June 30, according to an SEC filing.

Meanwhile, Sandoz is waiting for the court to act on its request for en banc review of the panel’s decision requiring biosimilars makers to give 180 days’ notice before an expected product launch. — Jonathon Shacat