Sandoz AG and Amgen Inc have reached an agreement to resolve all patent litigation related to Sandoz’s U.S. denosumab biosimilars, Jubbonti and Wyost. The agreement clears the way for the launch of these biosimilars on May 31, 2025, or earlier under certain circumstances.
Sandoz received FDA approval for Jubbonti and Wyost, the first and only denosumab biosimilars, in March 2024. These biosimilars are interchangeable with and approved for all indications of the reference medicines, Prolia and Xgeva. Patent infringement proceedings were initially filed by Amgen in May 2023, alleging that Sandoz infringed on up to 21 patents protecting Prolia and Xgeva. The litigation has now been resolved.