Amgen v. Sandoz: Next Biosimilar Bout Begins Over State Law Claims
In the ongoing Zarxio dispute, US appeals court takes up question left open by Supreme Court as to whether innovator company can seek remedy under state law if a biosimilar sponsor does not engage in the "patent dance" by providing its application and manufacturing information.
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Court says biosimilar sponsors may provide 180-day notice of marketing prior to FDA approval; Federal Circuit to decide if innovators can seek an injunction under state law if sponsors do not provide application and manufacturing information; Justice Breyer offers FDA invitation to weigh in.
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.
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.