FDA Approves Denosumab-Mobz as Biosimilar for Prolia, Xgeva

The FDA approved denosumab-mobz (Boncresa, Oziltus) as biosimilars for Prolia and Xgeva, respectively. Denosumab is a monoclonal antibody that inhibits bone resorption and is used for osteoporosis- and oncology-related conditions.¹

"Biosimilars are the next wave of affordable medicines in the US, expanding access to life-changing biologics for millions of patients,” Chirag and Chintu Patel, co-CEOs of Amneal, said in a news release.² “With the addition of 2 denosumab biosimilars, Amneal now has 5 commercial biosimilars, strengthening our position in this rapidly growing category. We view biosimilars as a major long-term growth vector within our Affordable Medicines segment.”

Denosumab is in a class of medication called RANK ligand inhibitors, which work to prevent bone loss by blocking receptors in the body that contribute to the decrease of bone breakdown. Further, it treats GCTB by blocking certain receptors in tumor cells that slow the tumor growth and treats high calcium levels by decreasing bone breakdown, which causes a release in calcium. The drug is a subcutaneous injection, which is injected by a physician or nurse in a medical officer's clinic. Frequency of injections may vary based on the indication. Additionally, a physician may prescribe calcium and vitamin D supplements with treatment.²

Prolia is 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.³

Furthermore, Xgeva is 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.³

Boncresa and Oziltus are only some of the biosimilar approvals for denosumab in 2025. Earlier in the year, the FDA approved denosumab-desu (Osvyrti, Jubereq), denosumab-dssb (Ospomyv, Xbryk), denosumab-bmwo (Stoboclo, Osenvelt), denosumab-bnht (Conexxence, Bomyntra), denosumab-nxxp (Bildyos, Bilprevda), and denosumab-kyqq (Bosaya, Aukelso), with denosumab-dssb being granted interchangeability status.³

The first biosimilar approved for denosumab was approved in 2024, and denosumab-bbdz (Wyost, Jubbonti) were the first approved biosimilar to receive interchangeability status for the drugs. This means the biosimilars can be substituted for denosumab at the pharmacy level and without prior approval for the prescribing physician.³

“The FDA approval of our denosumab biosimilars marks a significant milestone for mAbxience and for our collaboration with Amneal,” Jurgen Van Broeck, CEO of mAbxience, said in a news release.¹ “This achievement reinforces our globalization strategy and our purpose of helping address unmet patient needs through innovation and reliable manufacturing.”

READ MORE: Biosimilars Resource Center

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REFERENCES

1. mAbxience and Amneal announce FDA approval of denosumab biosimilars referencing Prolia and Xgeva. News release. mAbxience. December 22, 2025. Accessed January 5, 2026. https://prnmedia.prnewswire.com/news-releases/mabxience-and-amneal-announces-fda-approval-of-denosumab-biosimilars-referencing-prolia-and-xgeva-302648226.html

2. MedlinePlus. December 15, 2025. Accessed January 5, 2026. https://medlineplus.gov/druginfo/meds/a610023.html

3. Gallagher A. FDA approves denosumab-desu as biosimilar to Prolia, Xgeva. Drug Topics. November 20, 2025. Accessed January 5, 2026. https://www.drugtopics.com/view/fda-approves-denosumab-desu-as-biosimilar-to-prolia-xgeva