Novartis ($NVS) and its Neupogen biosimilar are steamrolling toward the U.S. market. But Amgen ($AMGN) hasn't given up stopping the product in its tracks. The biotech last week urged a California court to block the biosimilar launch, with FDA approval expected as soon as March 9.
U.S. District Judge Richard Seeborg set a hearing on a preliminary injunction March 2, with a flurry of filings and depositions due before then. The injunction request is part of a patent suit Amgen filed last November.
If the judge decides to grant Amgen's request, that's a big deal for Novartis, whose Sandoz unit has been laboring to get its Neupogen biosimilar, Zarxio, to market in the U.S.. An FDA advisory panel gave Sandoz a thumbs-up for its product last month, paving the way for an agency nod next month. Sandoz would have to delay its launch, giving biosim rivals a chance to catch up. For Amgen, of course, it would mean more time sans Neupogen generics; the drug brought in an estimated $1.2 billion last year. Plus, Novartis' version is on the market as Zarzio in more than 40 countries where biosimilar regulations are already in force. Sandoz says it's the top-selling copy of Amgen's drug around the world--and it's just waiting to crack the market waiting in the U.S.
But other biotechs and biosim developers are watching this case for what it might say about the path to market. At the heart of this case is notification under the Biologics Price Competition and Innovation Act--when, exactly, biosim developers are required to hand over particular info about their plans to the brand-name drugmaker.
Amgen claims Sandoz deliberately withheld documents it was bound to hand over--its application for FDA approval, along with a required description of Sandoz's manufacturing processes--until after the prescribed deadline. The BCPIA requires biosim developers to share that information ahead of time, to give branded drugmakers a chance to sift through and decide whether they have grounds for patent infringement lawsuits.
Sandoz did notify Amgen of its plans to launch--which has to happen at least 180 days in advance--but that didn't exactly help Amgen decide about its patent strategy, the lawsuit claims. Sandoz sent that letter last July.
Amgen wants the court to not only stop the launch for now, but to stop it long enough for the two companies to wrangle over Neupogen's patents. How the court rules--and how the patent fight plays out after that--promises to help shape the legal pathway for biosims of all kinds.
Even more important for biosim developers, Amgen demands a different notification schedule. Amgen wants the court to say Sandoz can't officially notify about its intent to market a Neupogen biosim until the product actually has FDA approval. That, in itself, would delay a launch till 6 months after the agency gives its blessing. If that rule were widely recognized, then every FDA-approved biosim would have to wait at the gate for 6 months.
- read the hearing schedule
- check out the original complaint
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