FDA's Worst Case Scenario: Supreme Court Might Defer To It On Biosimilars
During oral arguments in Sandoz v Amgen, justices suggest FDA issue rule-making on whether biosimilar sponsors can give early notification of launches and need to follow all the steps in the patent dance. The agency has explicitly said it wants to be left out of it.
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High court set to determine timing of biosimilar marketing and how parties handle patent disputes in Sandoz v. Amgen. Stakeholders say the outcome will impact innovation, access to biosimilars and future litigation.
Biosimilar sponsors won a partial victory in the battle over the meaning of the US biosimilars statute as an appeals court found that the patent exchange process laid out in the law is optional1. But avoiding the disclosure and negotiation procedures or 'patent dance' in the Biologics Price Competition and Innovation Act opens them up to litigation over a larger number of patents, which could be problematic for biosimilars of newer biologics.
Novartis division delays Zarxio rollout to let courts consider Amgen’s request for preliminary injunction after earlier ruling in Sandoz’s favor; separately, FDA denies Amgen’s bid to require biosimilar applicants to certify they’ll join the patent dance.