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Hikma Announces U.S. Launch of Prolia® / Xgeva® Biosimilars Enoby™ / Xtrenbo™ (denosumab-qbde)

by Robert S. Schwartz, Ph.D.
January 22, 2026

On January 19, 2026, Hikma announced the launch of Enoby™ / Xtrenbo™ (denosumab-qbde), biosimilars of Amgen’s Prolia® / Xgeva® (denosumab), following their FDA-approval in September 2025.  The launch is pursuant to a settlement agreement ending the BPCIA litigation in Case No. 1:25-cv-12152 (D.N.J.) (previously reported Prolia® / Xgeva® Biosimilar Updates: FDA Approves Accord’s Osvyrti® / Jubereq®, Amgen and Hikma Settle BPCIA Litigation).  Under a licensing agreement, Gedeon Richter is responsible for manufacturing Enoby™ / Xtrenbo™, and Hikma is responsible for their commercialization in the U.S.

Enoby™ / Xtrenbo™ are the fourth set of Prolia® / Xgeva® biosimilars to launch in the U.S. following Jubbonti® / Wyost® (denosumab-bbdz) in June 2025 (previously reported Sandoz Launches Jubbonti® / Wyost® (denosumab-bbdz) as First Prolia® / Xgeva® Interchangeable Biosimilars), and Stoboclo® / Osenvelt® (denosumab-bmwo) and Conexxence™ / Bomyntra™ (denosumab-bnht) in July 2025 (previously reported Fresenius Kabi and Celltrion Launch Prolia® / Xgeva® (denosumab) Biosimilars Conexxence™ / Bomyntra™ and Stoboclo® / Osenvelt®).

Numerous BPCIA patent litigations are ongoing for Prolia® / Xgeva® biosimilars, including those related to Shanghai Henlius Biotech’s Bildyos® / Bilprevda® (denosumab-nxxp), Case No. 1:25-cv-12160 (D.N.J.); Alvotech / Dr. Reddy’s AVT03 (denosumab), Case No. 1:25-cv-17277 (D.N.J.); Amneal / mAbxience’s Boncresa™ / Oziltus™ (denosumab-mobz), Case No. 1:25-cv-17278 (D.N.J.); and Alkem / Enzene’s ENZ215 (denosumab), Case No. 1:25-cv-17596 (D.N.J.).

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

For more information on these and other biosimilars and related patent disputes, please visit BiologicsHQ.com.

 

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The author 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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