Amgen deal frees Sandoz to launch Prolia and Xgeva biosimilars next year

30 April 2024

Swiss generic and biosimilar medicines company Sandoz (SWX: SDZ) has reached agreement with US biotech major Amgen (Nasdaq: AMGN) to resolve all patent disputes between the two companies relating to the former company’s US Food and Drug Administration (FDA)-approved denosumab biosimilars.

Patent infringement proceedings were initially filed by Amgen in the US Federal District Court for the District of New Jersey in May of 2023 pursuant to the Biologics Price Competition and Innovation Act (BPCIA).

Resolution of the BPCIA litigation followed months of vigorous defense by Sandoz against claims by Amgen that the company infringed up to 21 patents expiring as late as 2037, protecting reference medicines Prolia and Xgeva.

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