On June 2, 2025, Sandoz announced the launch of Jubbonti® / Wyost® (denosumab-bbdz), the first Prolia® / Xgeva® (denosumab) interchangeable biosimilars to launch in the U.S. Jubbonti® is indicated for increasing bone mass in patients with osteoporosis, prostate cancer, and breast cancer. Wyost®, interchangeable with Xgeva®, is indicated for prevention and treatment of skeletal-related events in patients with various cancers, including multiple myeloma, solid tumors, and giant cell tumor of bone.
The launch comes pursuant to a settlement agreement between Sandoz and Amgen in April 2024 (Case No. 1:23-cv-02406 (D.N.J.)) (previously reported Amgen and Sandoz Settle Prolia® / Xgeva® Biosimilar Litigation). Earlier this year, Celltrion settled its case with Amgen, No. 1:24-cv-06497 (D.N.J.) / MDL 1:25-md-03138 (D.N.J.), with a launch date for its biosimilars Stoboclo® / Osenvelt® (denosumab-bmwo) on or after June 1, 2025 (previously reported Celltrion and Amgen Reach Settlement in Prolia® / Xgeva® Biosimilar Litigation). At the time of this writing, a launch date for Stoboclo® / Osenvelt® has not yet been announced. Fresenius Kabi also settled its litigation, Case No. 1:25-cv-01080 (D.N.J.) / MDL 1:25-md-03138 (D.N.J.), with a launch date for Conexxence™ / Bomyntra™ (denosumab-bnht) in the second half of 2025 (previously reported Prolia® / Xgeva® (denosumab) Biosimilar Updates: Celltrion Biosimilar Approval, Amneal aBLA Filing, and Fresenius Kabi Litigation Settlement).
Litigations are ongoing for Samsung Bioepis’s biosimilars Ospomyv™ / Xbryk™ (denosumab-dssb), Case No. 1:24-cv-08417 (D.N.J.) / MDL 1:25-md-03138 (D.N.J.), and Accord / Intas’s proposed biosimilar INTP23, Case No. 1:25-cv-01305 (D.N.J.) / MDL 1:25-md-03138 (D.N.J.). Accord agreed to a consent injunction until October 1, 2025.
Numerous additional denosumab aBLAs are pending at the FDA, including Teva’s TVB-009P, Organon / Shanghai Henlius Biotech’s HLX14, Gedeon Richter / Hikma’s RGB-14, Amneal / mAbxience’s denosumab, and Alvotech / Dr. Reddy’s AVT03.
Amgen reported FY24 U.S. sales for Prolia® of $2.885 billion, and $1.507 billion for Xgeva®.
For an overview of Prolia® / Xgeva® patent proceedings and aBLAs, please visit Spotlight On: Prolia® / Xgeva® (denosumab) / Jubbonti® / Wyost® (denosumab-bbdz) / Ospomyv™ / Xbryk™ (denosumab-dssb) / Stoboclo® / Osenvelt® (denosumab-bmwo) / Conexxence™ / Bomyntra™ (denosumab-bnht).
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The author would like to thank April Breyer Menon for her contributions to this article.
