The US district court has rejected Amgen’s (Nasdaq: AMGN) request for a preliminary injunction to block Sandoz’s Neupogen (filgrastim) biosimilar Zarxio (filgrastim-sndz).
Zarxio was cleared by the FDA in March 2015, becoming the first approved biosimilar in the USA. US District Judge Richard Seeborg said that the dispute between Amgen and Sandoz was based around differing interpretations of the Biologics Price Competition and Innovation Act.
Novartis (NOVN: VX), the parent company of Sandoz, has not specified if it will launch Zarxio prior to completing the appeals process.
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