Ringside For Zarxio At Supreme Court: Biosimilar Stakeholders Line Up
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.
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Interviews with US payers suggest that at first they are more likely to focus on promoting biosimilars in treatment-naïve patients, as opposed to switching those on branded drugs, according to a new Datamonitor report.
US court dismisses Genentech suit over Amgen's patent dance moves; Janssen v. Celltrion trial is postponed as parties fight over Janssen's standing to sue; and Amgen wants to bar AbbVie citizen petition filers from seeing its Amjevita information.
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.