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®. Under the terms of the agreement, Sandoz may enter the US market with a biosimilar version of Prolia® and Xgeva® on May 31, 2025, or earlier under certain circumstances if customary acceleration provisions are triggered.
Sandoz received FDA approval for the first and only denosumab biosimilars, Jubbonti® and Wyost®, on March 5, 2024. Jubbonti® and Wyost® are interchangeable with and approved by FDA for all indications of reference medicines Prolia® and Xgeva®. They have the same dosage form, route of administration, dosing regimen and presentation as the respective reference medicines.
The settlement clears the path to bring both Jubbonti® and Wyost® to the US market on May 31, 2025, or earlier under certain circumstances. Bringing denosumab to market allows Sandoz to further its Purpose of pioneering access for patients, by providing them with affordable high-quality medicines.
The terms of the agreement will not impact Sandoz’s previously disclosed 2024 guidance.