On June 3, 2015, The Federal Circuit heard oral arguments in the ongoing legal battle over the first FDA-approved biosimilar, Zarxio (filgrastim-sndz). Specifically, the court heard arguments on Amgen's appeal of the District Court for the Northern District of California's denial of Amgen's motion for a preliminary injunction seeking to prevent Sandoz from marketing Zarxio until the district court decided the then-pending motions for judgment on the pleadings or until the parties were placed in the position they would have been in had Sandoz complied with the BPCIA provisions. In this article, Finnegan attorneys Sanya Sukduang and Aaron Gleaton Clay share their perspectives on the legal issues associated with the commercial release of the first FDA-approved biosimilar. Specifically, they review the oral arguments presented to the Federal Circuit on June 3, 2015 in the ongoing Amgen v. Sandoz dispute. View the full article here.
Previously published by BioPharm International
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