FDA Approves Denosumab Biosimilars, Osvyrti and Jubereq, for Reference Products’ Indications

The FDA approved Osvyrti and Jubereq (denosumab-desu; Accord BioPharma), 2 denosumab biosimilars referencing Prolia and Xgeva (Amgen), respectively, for the same indications as their reference products.¹

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

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

Additionally, the treatment carries a boxed warning for severe hypocalcemia in patients with advanced kidney disease. Osvyrti is approved with a REMS program.¹

Like its reference product Xgeva, Jubereq 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

"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 BioPharma North America, said in a news release. "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."¹

According to the manufacturer, the FDA approval of Osvyrti and Jubereq is based on results from 2 trials, a phase 1 trial and a phase 3 trial, that met their primary end points. The phase 1 trial was a randomized, double-blind, 3-arm pharmacokinetic study that compared Jubereq to Xgeva in healthy adult males, and it demonstrated that pharmacokinetic parameters were comparable between the 2 products.¹

The phase 3 study was a randomized, double-blind, active-controlled, parallel-arm, multicenter study that compared the pharmacokinetics and pharmacodynamics, efficacy, and safety of Osvyrti to Prolia in postmenopausal women with osteoporosis. These results demonstrate that Osvyrti and its reference product are highly similar and do not exhibit any clinically meaningful differences in pharmacokinetics, pharmacodynamics, safety, or efficacy.¹

Alongside Conexxence and Bomyntra (denosumab-bnht; Fresenius Kabi) and Stoboclo and Osenvelt (denosumab-bmwo; Celltrion USA), this is the third pair of biosimilars to receive approval or an interchangeability designation since October 2025.^2,3 Other denosumab biosimilars approved earlier this year include Ospomyv and Xbryk (denosumab-dssb; Samsung Bioepis Co.)⁴; Bildyos and Bilprevda (denosumab-nxxp; Shanghai Henlius Biotech, Organon)⁵; and Bosaya and Aukelso (denosumab-kyqq; Biocon Biologics Ltd.).⁶

"Osvyrti and Jubereq are the first biosimilars Accord has developed completely on its own, and we will manufacture these products internally without a third-party partnership," Binish Chudgar, chairman and managing director of Intas Pharmaceuticals, said in the news release. "We believe biosimilars are here to stay, and we are investing in their promise of cost savings for patients and the entire US health care system."¹

REFERENCES

1. PR Newswire. Accord BioPharma, Inc. Announces FDA Approval of Denosumab Biosimilars OSVYRTI® (denosumab-desu) and JUBEREQ® (denosumab-desu). News release. November 20, 2025. Accessed November 20, 2025. https://www.prnewswire.com/news-releases/accord-biopharma-inc-announces-fda-approval-of-denosumab-biosimilars-osvyrti-denosumab-desu-and-jubereq-denosumab-desu-302621107.html

2. McGovern G. FDA Grants Interchangeability Designation to Denosumab Biosimilars Stoboclo and Osenvelt. Pharmacy Times. October 30, 2025. Accessed November 20, 2025. https://www.pharmacytimes.com/view/fda-grants-interchangeability-designation-to-denosumab-biosimilars-stoboclo-and-osenvelt

3. McGovern G. Denosumab Biosimilars Conexxence and Bomyntra Receive Interchangeability Designation. Pharmacy Times. October 30, 2025. Accessed November 20, 2025. https://www.pharmacytimes.com/view/denosumab-biosimilars-conexxence-and-bomyntra-receive-interchangeability-designation

4. Halpern L. FDA Approves Biosimilar Denosumab-dssb to Treat Osteoporosis-, Cancer-Related Bone Loss. Pharmacy Times. February 17, 2025. Accessed November 20, 2025.

5. McGovern G. FDA Approves Bildyos and Bilprevda, Biosimilars of Reference Denosumab. Pharmacy Times. September 2, 2025. Accessed November 20, 2025. https://www.pharmacytimes.com/view/fda-approves-bildyos-and-bilprevda-biosimilars-of-reference-denosumab

6. McGovern G. FDA Approves Bosaya and Aukelso, Biosimilars to Reference Denosumab. Pharmacy Times. September 17, 2025. Accessed November 20, 2025. https://www.pharmacytimes.com/view/fda-approves-bosaya-and-aukelso-biosimilars-to-reference-denosumab