Sandoz’s Biosimilar Launch Eyed For May 11 Or Earlier, Absent Court Injunction

26 Mar 2015

Novartis division delays Zarxio rollout to let courts consider Amgen’s request for preliminary injunction after earlier ruling in Sandoz’s favor; separately, FDA denies Amgen’s bid to require biosimilar applicants to certify they’ll join the patent dance.

Sandoz Inc. is once again temporarily delaying the launch of Zarxio (filgrastim-sndz), its biosimilar to Neupogen (filgrastim), while a dispute with Amgen Inc. over the Biologics Price Competition and Innovation Act’s patent information exchange provisions makes its way through the court system.

The Novartis AG subsidiary will not launch Zarxio in the U.S. until the earlier of May 11 or a...