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Amgen and Samsung Bioepis Reach Settlement in Prolia® / Xgeva® Biosimilar Litigation

by Robert S. Schwartz, Ph.D.; Leah Watson
September 9, 2025

On September 5, 2025, Amgen and Samsung Bioepis reached a settlement in Case No. 1:24-cv-08417 (D.N.J.) / 1:25-md-3138 (D.N.J.), and the Court entered a consent judgment. The litigation related to Samsung Bioepis’s Prolia® / Xgeva® (denosumab) interchangeable biosimilars Ospomyv™ / Xbryk™ (denosumab-dssb), which were approved by the FDA on February 13, 2025 (previously reported FDA Approves Second Prolia® / Xgeva® (denosumab) Interchangeable Biosimilars: Samsung Bioepis’s Ospomyv™ / Xbryk™). The consent order held that the claims of Amgen’s U.S. patents asserted against Samsung Bioepis were valid, enforceable, and infringed by Ospomyv™ / Xbryk™. The terms of the settlement agreement have not been publicly disclosed.

This is the fifth settlement related to Prolia® / Xgeva® biosimilars. Previous settlements include Amgen v. Sandoz, Case No. 1:23-cv-02406 (D.N.J.) in April 2024 related to interchangeable biosimilars Jubbonti® / Wyost® (denosumab-bbdz) (previously reported Amgen and Sandoz Settle Prolia® / Xgeva® Biosimilar Litigation); Amgen v. Celltrion, Case No. 1:24-cv-06497 (D.N.J.) in January 2025 related to Stoboclo® / Osenvelt® (denosumab-bmwo) (previously reported Celltrion and Amgen Reach Settlement in Prolia® / Xgeva® Biosimilar Litigation); Amgen v. Fresenius Kabi, Case No. 1:25-cv-01080 (D.N.J.) / MDL 1:25-md-03138 (D.N.J.) in March 2025 related to Conexxence™ / Bomyntra™ (denosumab-bnht) (previously reported Prolia® / Xgeva® (denosumab) Biosimilar Updates: Celltrion Biosimilar Approval, Amneal aBLA Filing, and Fresenius Kabi Litigation Settlement); and Amgen v. Accord, Case No. 1:25-cv-01305 (D.N.J.) / MDL 1:25-md-03138 (D.N.J.) in July 2025 related to INTP23 (previously reported Amgen and Accord Settle Prolia® / Xgeva® BPCIA Litigation over INTP23).  Sandoz’s biosimilars were launched in June 2025, and Celltrion and Fresenius Kabi’s biosimilars launched in July 2025 (previously reported Sandoz Launches Jubbonti® / Wyost® (denosumab-bbdz) as First Prolia® / Xgeva® Interchangeable Biosimilars; Fresenius Kabi and Celltrion Launch Prolia® / Xgeva® (denosumab) Biosimilars Conexxence™ / Bomyntra™ and Stoboclo® / Osenvelt®).

Three lawsuits for Prolia® / Xgeva® biosimilars remain pending: Gedeon Richter / Hikma’s RGB-14 (Case No. 1:25-cv-12152 (D.N.J.)), Shanghai Henlius Biotech / Organon’s Bildyos® / Bilprevda® (denosumab-nxxp) (Case No. 1:25-cv-12160 (D.N.J.)), and Biocon Biologics’ Bosaya™ / Aukelso™ (denosumab-kyqq) (Case No. 1:25-cv-13358 (D.N.J.) / MDL 1:25-md-03138 (D.N.J.)).

Amgen reported FY24 U.S. sales for Prolia® of $2.885 billion, and $1.507 billion for Xgeva®.

For more information about these and other biosimilar patent disputes, please 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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