Novartis' ($NVS) Sandoz may have the first FDA-approved biosimilar in Zarxio, but it doesn't have permission to launch--and it won't be getting that until September, the country's top patent court ruled Tuesday.
As part of a patent infringement lawsuit, the U.S. Court of Appeals for the Federal Circuit decided to keep an injunction on the drug--a copy of Amgen's ($AMGN) Neupogen--until Sept. 2, Reuters reports. The court initially blocked Zarxio's rollout in May; the plan was to keep the med off the U.S. market while it resolved Amgen's appeal of a lower-court ruling that gave the biosim a green light to launch.
In June, though, Novartis asked the court to reconsider, rejecting claims from Amgen's lawyer that Sandoz "didn't follow the rules" when it comes to how notice on biosimilar launches should be given. It twice made appropriate disclosures to Amgen that it planned to bring Zarxio to market, once when applying for FDA approval and once when it nabbed the agency's thumbs up, it argued.
But that wasn't enough to convince the court to take the brakes off the therapy, and now, Amgen will be able to keep a grip on the $839 million in U.S. revenues that Neupogen hauled in last year--at least, for a couple more months. The biotech giant, though, will take what it can get, with second-best-seller Enbrel also facing new competition from next-gen psoriasis-fighters.
And meanwhile, Sandoz may not let the legal battle end here. "Our understanding is that this ruling could be appealed to the U.S. Supreme Court," Evercore ISI analyst Mark Schoenebaum wrote in a Tuesday note to clients.
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