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