Last month, a U.S. appeals court blocked Novartis' ($NVS) biosimilar version of Amgen's ($AMGN) blockbuster Neupogen while the companies worked out a patent dispute. Unsurprisingly, though, Novartis wants that ban lifted, and now it's asking the court to do just that.
The Swiss drugmaker is hoping the U.S. Court of Appeals for the Federal Circuit will let it roll out its copy of Amgen's $1.2 billion-a-year seller, making it the first biosimilar available in the country. But that'll depend on whether a panel decides Novartis' generics unit, Sandoz, made appropriate disclosures to Amgen that it planned to bring its copy out, Reuters reports.
As Sandoz's lawyer contends, the company did so twice--once when applying for FDA approval for Zarxio and once when it nabbed the agency's green light. Amgen's lawyer, though, says Sandoz "didn't follow the rules" when it comes to how notice on biosimilar launches should be given.
Amgen, for its part, is hoping to keep a lock on the $839 million in U.S. revenues that Neupogen hauled in last year, especially with its second-best-seller, Enbrel, up against new competition, too. The psoriasis-fighter has a new rival in Novartis' Cosentyx, the first in a wave of next-gen treatments that are coming up quickly through Big Pharma's pipelines.
Even if the court does take the brakes of Zarxio, though, it could be awhile before it gains any serious market-share traction--and Novartis CEO Joe Jimenez is the first to admit it. As he told Reuters last August, doctors, patients and payers will need some time to figure out how to respond to biosimilars once they arrive on the market, and he thinks they won't make a major splash until around 2020.
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