FDA Approves Denosumab-Desu as Biosimilar to Prolia, Xgeva

The FDA has approved denosumab-desu (Osvyrti, Jubereq) as a biosimilar to denosumab (Prolia, Xgeva, respectively). The agency approved both medications for all the same indications as their respective reference products.¹

"Both Osvyrti and Jubereq have been approved for a wide variety of bone-related indications, including osteoporosis and bone loss from the treatment of certain kinds of cancer," Chrys Kokino, president of Accord North America, said in a news release.¹ "These biosimilars have the potential to provide a large number of patients with treatment alternatives that lessen cost as a barrier to accessing proven therapies. At Accord, we are passionate about leading biosimilar adoption, and Osvyrti and Jubereq represent significant steps in our mission to make biosimilars more accessible."

Osvyrti was approved for the treatment of postmenopausal women with osteoporosis at high risk for fracture; to increase bone mass in men with osteoporosis at high risk for fracture; for the treatment of glucocorticoid-induced osteoporosis in men and women at high risk for fracture; to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer; and to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.¹

Jubereq was approved for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors, for the treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity, and for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.¹

The approval was based on results from 2 trials, including a phase 1 trial that compared the pharmacokinetics of Jubereq with Xgeva in healthy adult males and a phase 3 trial that compared the pharmacokinetics, efficacy, and safety of Osvyrti with Prolia in postmenopausal women with osteoporosis.¹

Earlier this year, the FDA also approved 5 other biosimilars for denosumab, including denosumab-dssb (Ospomyv, Xbryk), denosumab-bmwo (Stoboclo, Osenvelt), denosumab-bnht (Conexxence, Bomyntra), denosumab-nxxp (Bildyos, Bilprevda), and denosumab-kyqq (Bosaya, Aukelso). Denosumab-dssb was also granted interchangeability status.^2-6

The first biosimilar for denosumab was approved in 2024, and denosumab-bbdz (Wyost, Jubbonti) was the first approved denosumab biosimilar to receive interchangeability status.²

Denosumab is a bone antiresorptive medication that is used to treat osteoporosis and various bone-related disorders. It is a total human IgG2 monoclonal antibody that binds to the receptor activator of NF-κB ligand (RANKL) and inhibits binding to the receptor activator of RANK.⁷

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REFERENCES

1. Accord BioPharma, Inc announces FDA approval of denosumab biosimilars Osvyrti (denosumab-desu) and Jubereq (denosumab-desu). News release. Accord BioPharma. November 20, 2025. Accessed November 20, 2025. https://prnmedia.prnewswire.com/news-releases/accord-biopharma-inc-announces-fda-approval-of-denosumab-biosimilars-osvyrti-denosumab-desu-and-jubereq-denosumab-desu-302621107.html

2. Gallagher A. FDA approves denosumab-kyqq as biosimilar for Prolia, Xgeva. Drug Topics. September 17, 2025. Accessed November 20, 2025. https://www.drugtopics.com/view/fda-approves-denosumab-kyqq-as-biosimilar-for-prolia-xgeva

3. Gallagher A. FDA approves biosimilars for Prolia, Xgeva. Drug Topics. September 2, 2025. Accessed September 17, 2025. https://www.drugtopics.com/view/fda-approves-biosimilars-for-prolia-xgeva

4. Gallagher A. FDA approves denosumab-bnht as biosimilar to Prolia, Xgeva. Drug Topics. March 27, 2025. Accessed September 17, 2025. https://www.drugtopics.com/view/fda-approves-denosumab-bnht-as-biosimilar-to-prolia-xgeva

5. Gallagher A. FDA approves denosumab-bmwo as biosimilar to Prolia, Xgeva. Drug Topics. March 4, 2025. Accessed September 17, 2025. https://www.drugtopics.com/view/fda-approves-denosumab-bmwo-as-biosimilar-to-prolia-xgeva

6. Gallagher A. FDA approves denosumab-dssb as biosimilar for Prolia, Xgeva. Drug Topics. February 17, 2025. Accessed September 17, 2025. https://www.drugtopics.com/view/fda-approves-denosumab-dssb-as-biosimilar-for-prolia-xgeva

7. Hildebrand GK, Patel P, Kasi A. Denosumab. In: StatPearls. StatPearls Publishing; 2025 Jan-. Updated February 28, 2024. Accessed September 17, 2025. https://www.ncbi.nlm.nih.gov/books/NBK535388/