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Sandoz Launches Jubbonti® / Wyost® (denosumab-bbdz) as First Prolia® / Xgeva® Interchangeable Biosimilars

by Robert S. Schwartz, Ph.D.
June 11, 2025

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).  For more information about these and other biosimilars and biosimilar patent disputes related to Prolia® / Xgeva®, please visit BiologicsHQ.

 

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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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