The FDA has approved denosumab-desu (Osvyrti) and denosumab-desu (Jubereq) in all the same indications as the biosimilars referencing denosumab (Prolia; Xgeva), respectively.1 Osvyrti and Jubereq represent the fourth and fifth biosimilar approvals for Accord BioPharma, which previously included trastuzumab-strt (Hercessi), ustekinumab-srlf (Imuldosa), and pegfilgrastim-cbqv (Udenyca), biosimilars referencing trastuzumab (Herceptin), ustekinumab (Stelara), and pegfilgrastim (Neulasta) respectively.2
“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, stated 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.”
Both approvals join an expanding array of denosumab biosimilars. Earlier in September 2025, the regulatory agency granted approval to denosumab-kyqq (Bosaya) and denosumab-kyqq (Aukelso) as biosimilars for reference denosumab (Prolia) and denosumab (Xgeva), respectively.3
What are the specific indications for Osvyrti and Jubereq?
In accordance with its indication, Osvyrti can be used to treat postmenopausal women with osteoporosis at high risk for fracture, increase bone mass in men with osteoporosis at high risk for fracture, treat glucocorticoid-induced osteoporosis in men and women at high risk for fracture, increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer, and increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer. Both Prolia and Osvyrti are approved with a REMS program.
Similarly, Jubereq can be used for the prevention of skeletal-related events in patients with multiple myeloma and in those with bone metastases from solid tumors. It is also approved for the treatment of adults and skeletally mature adolescents with giant cell tumor of the bone that is unresectable or where surgical resection is likely to result in severe morbidity, and for the treatment of hypercalcemia in malignant disease that is refractory to bisphosphonate therapy.
What data served as the basis for the new indications?
The approvals of Osvyrti and Jubereq are based on positive data from phase 1 and phase 3 trials. The phase 1 was a randomized, double-blind, 3-arm pharmacokinetic (PK) study designed to compare Jubereq with Xgeva in healthy adult males. Results illustrated comparable PK parameters between the two products.
The phase 3 was a randomized, double-blind, active-controlled, parallel arm, multicenter study that evaluated the efficacy and safety of Osvyrti vs Prolia in postmenopausal women with osteoporosis. PK and pharmacodynamic (PD) activity was also examined. Data from the latter trial demonstrated that Osvyrti and Prolia were highly similar, revealing no clinically meaningful differences in terms of PK, PD, safety, or efficacy.
What is the significance of the approvals and what are the next steps?
“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, added. “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.”
Commercialization of Osvyrti and Jubereq is underway to bring both agents to the marketplace in 2026, and more details are expected closer to their launch.
References
- Accord BioPharma, Inc. announces FDA approval of denosumab biosimilars Osvyrti (denosumab-desu) and Jubereq (denosumab-desu). News release. Accord BioPharma, Inc. 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?tc=eml_cleartime
- Accord BioPharma. Our Therapies. Accessed November 20, 2025. https://www.accordbiopharma.com/ourtherapies/
- Biocon Biologics receives U.S. Food and Drug Administration approval for Bosaya and Aukelso, denosumab biosimilars. News release. Biocon Biologics. September 17, 2025. Accessed November 20, 2025. https://www.biocon.com/biocon-biologics-receives-u-s-food-and-drug-administration-approval-for-bosaya-and-aukelso-denosumab-biosimilars
