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Amgen Settles BPCIA Litigation Against Henlius Over Prolia® / Xgeva® (denosumab) Biosimilars

by Leah Watson; Robert S. Schwartz, Ph.D.
April 1, 2026

On March 31, 2026, Amgen reached a settlement with Shanghai Henlius Biotech, resolving BPCIA litigation No. 1:25-cv-12160 (D.N.J.) / 1:25-md-03138 (D.N.J.) concerning Prolia® / Xgeva® (denosumab) biosimilars Bildyos® / Bilprevda® (denosumab-nxxp). This is the eighth Prolia® / Xgeva® biosimilar litigation to settle.

The District of New Jersey entered a consent order and judgment resolving the dispute. The order provides that the asserted claims of 26 Amgen patents, covering denosumab, pharmaceutical compositions containing denosumab, and methods of manufacture, are valid, enforceable, and infringed by the manufacture, use, sale, or importation of Bildyos® / Bilprevda®. The remaining claims and counterclaims were dismissed with prejudice, with each party bearing its own costs.

The consent judgment did not include an injunction or specify a date for market entry. Other denosumab biosimilars have already launched in the United States beginning in June 2025, including Sandoz’s Jubbonti® / Wyost® (denosumab-bbdz), Celltrion’s Stoboclo® / Osenvelt® (denosumab-bmwo), Fresenius Kabi’s Conexxence™ / Bomyntra™ (denosumab-bnht), and Hikma’s Enoby™ / Xtrenbo™ (denosumab-qbde) (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®; Hikma Announces U.S. Launch of Prolia® / Xgeva® Biosimilars Enoby™ / Xtrenbo™ (denosumab-qbde)).

Amgen reported FY25 U.S. sales for Prolia® of $2.978 billion, and $1.355 billion for Xgeva®.

For more information about these and other biosimilars, 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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