FDA Approves Denosumab Biosimilars Boncresa and Oziltus for Osteoporosis-, Cancer-Related Bone Loss

The FDA approved 2 denosumuab biosimilars, Boncresa and Oziltus (denosumab-mobz; Amneal Pharmaceuticals, mAbxience), for all indications of their respective reference products, Prolia and Xgeva (Amgen).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 Pharmaceuticals, said in a news release.¹

Like its reference product, Prolia, Boncresa is indicated for the treatment of patients in several categories¹:

• Postmenopausal women with osteoporosis who are at a high risk of fracture
• Men with osteoporosis who are at a high risk of fracture and need to increase bone mass;
• Men and women with glucocorticoid-induced osteoporosis who are at a high risk of fracture;
• Men receiving androgen deprivation therapy for nonmetastatic prostate cancer who are at a high risk of fracture and need to increase bone mass; and
• Women receiving adjuvant aromatase inhibitor therapy for breast cancer who are at a high risk of fracture and need to increase bone mass.

Prolia has a boxed warning for severe hypocalcemia in patients with advanced chronic kidney disease, which can be life-threatening. Pregnancy must be ruled out prior to treatment. In postmenopausal women, reported adverse events (AEs) related to treatment included back pain, musculoskeletal pain, hypercholesterolemia, and cystitis. Back pain, joint pain, and nasopharyngitis were also frequently reported by men.¹

Like its reference product Xgeva, Oziltus is also indicated for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors; 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 treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.¹

The most serious reported AE for Xgeva was dyspnea, with other reactions including fatigue, nausea, and hypophosphatemia. For patients who were treated for bone metastases, common AEs were fatigue and nausea, whereas those with multiple myeloma frequently experienced gastrointestinal issues and anemia. Cases of giant cell tumor and hypercalcemia of malignancy showed frequent pain, nausea, and headache. The manufacturer warns that fetal harm can occur, and females of reproductive potential should use effective contraception while receiving treatment with Xgeva.¹

Both drugs should be administered by a health care provider. Additionally, patients should be advised by their providers to maintain serum calcium levels and to seek medical attention for an allergic reaction.¹

This year, the FDA approved multiple biosimilars referencing denosumab for the treatment of osteoporosis- and cancer-related bone loss. These include²:

• Xbryk (denosumab-dssb 120-mg vial; Samsung Bioepis Co) and Ospomyv (denosumab-dssb 60-mg prefilled syringe; Samsung Bioepis Co);
• Stoboclo and Osenvelt (denosumab-bmwo; Celltrion USA), which later received an interchangeability designation in October 2025;
• Conexxence and Bomyntra (denosumab-bnht; Fresenius Kabi), which also received an interchangeability designation in October 2025;
• Bildyos (denosumab-nxxp injection 60 mg/mL) and Bilprevda (denosumab-nxxp 120 mg/1.7 mL; Shanghai Henlius Biotech, Organon);
• Bosaya (denosumab-kyqq 60 mg/mL subcutaneous injection) and Aukelso (denosumab-kyqq 120 mg/1.7 mL subcutaneous injection; Biocon Biologics Ltd.), which simultaneously received interchangeability designations; and
• Osvyrti and Jubereq (denosumab-desu; Accord BioPharma).

“The FDA approval of our denosumab biosimilars marks a significant milestone for mAbxience and for our collaboration with Amneal. It reflects the strength of our scientific capabilities, our commitment to the highest quality standards, and our shared ambition to expand access to affordable, high-quality biologic medicines in the United States. This achievement reinforces our globalization strategy and our purpose of helping address unmet patient needs through innovation and reliable manufacturing,” Jurgen Van Broeck, CEO of mAbxience, said in the news release.¹

REFERENCES

1. Amneal Pharmaceuticals. Amneal Announces FDA Approval of Denosumab Biosimilars Referencing Prolia® and XGEVA®. News release. December 22, 2025. Accessed December 23, 2025. https://investors.amneal.com/news/press-releases/press-release-details/2025/Amneal-Announces-FDA-Approval-of-Denosumab-Biosimilars-Referencing-Prolia-and-XGEVA/default.aspx

2. McGovern G. FDA Approves Denosumab Biosimilars, Osvyrti and Jubereq, for Reference Products’ Indications. Pharmacy Times. November 20, 2025. Accessed December 23, 2025. https://www.pharmacytimes.com/view/fda-approves-denosumab-biosimilars-osvyrti-and-jubereq-for-reference-products-indications