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Amgen and Sandoz Settle Prolia® / Xgeva® Biosimilar Litigation

by Damineh Morsali, Ph.D.; Robert S. Schwartz, Ph.D.
April 30, 2024

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.

For more information about these and other biosimilar patent disputes, visit BiologicsHQ.

 

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

    Methodology

    Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.

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