Amgen and Sandoz reached a settlement in Case No. 1:23-cv-02406 (D.N.J.) on April 29 just hours before a New Jersey District Court Judge (Christine O’Hearn) was scheduled to announce her ruling on Amgen’s preliminary injunction against Sandoz’s Jubbonti^® / Wyost^® (denosumab-bddz), interchangeable biosimilars of Amgen’s Prolia^® / Xgeva^® (denosumab), FDA-approved on March 5, 2024.

The parties agreed in a Binding Term Sheet to an injunction that prohibits Sandoz from selling Jubbonti^® / Wyost^® until February 19, 2025, and as part of the stipulated agreement Sandoz conceded to the validity and infringement of Amgen’s U.S. Pat. No. 7,364,736.  After the case was dismissed, Sandoz announced it had reached the final terms of its settlement agreement with Amgen that allows Jubbonti^® / Wyost^® to enter the U.S. market on May 31, 2025, or earlier under certain circumstances if acceleration provisions are triggered.

According to Bloomberg, combined U.S. sales for Prolia^® ($2.7 B) and Xgeva^® ($1.5B) accounted for more than 15% of Amgen’s 2023 total revenue.

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The authors would like to thank April Breyer Menon for her contributions to this article.