Denosumab Biosimilars |
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The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of the denosumab biosimilars Osvyrti (as a 60-mg pre-filled syringe) and Jubereq (as a 120mg vial), for use across all autoimmune and oncology indications of the reference products denosumab (Prolia) and denosumab (Xgeva), respectively.1
Osvyrti, Accord Healthcare’s second osteoporosis biosimilar, received a positive opinion from CHMP for the following indications:
For the treatment of postmenopausal women and men with osteoporosis who are at an increased risk of fractures
For the treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures, reducing the likelihood of vertebral fractures
For the treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture
Jubereq carries the following indications:
For the prevention of skeletal-related events (including pathological fractures, radiation to bone, spinal cord compression, or bone surgery) in adult patients with advanced malignancies involving bone
For the treatment of adult and skeletally mature adolescent patients with giant cell tumour of bone that is unresectable or where surgical resection would likely result in severe morbidity
"At Accord, we are dedicated to transforming patients' lives, and the recent CHMP [positive opinion for] these vital medicines is a significant milestone,” Joe Dunford, the vice president of Specialty Brands at Accord, stated in a news release. “Osvyrt enhances our bone health portfolio, joining Sondelbay, our previously launched teriparatide biosimilar. Additionally, Jubereq expands our oncology product portfolio and underscores our commitment to advancing our specialty business and driving innovation in oncology—a field in which we have a rich heritage. As a market leader in oncology, we offer over 54 oncology and oncology-related treatments, including small molecule generics, biosimilars, and new chemical entities. This makes us one of the largest suppliers of chemotherapy products in Europe.”
According to Accord, this endorsement facilitates market authorization, and the company plans to launch denosumab following the patent expiration of the originator brands, Prolia and Xgeva, in November 2025.
Osvyrti and Jubereq are the latest in a line of denosumab biosimilars to approach potential approval in Europe. In February 2025, the European Commission approved Obodence and Xbryk for use in the same indications as the respective reference drugs, Prolia and Xgeva.2
In the EU, Obodence is indicated for the treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures; treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures; and treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture. Xbryk is approved for the prevention of skeletal-related events in adults with advanced malignancies involving bone; and 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.
Denosumab-dssb (Ospomyv) and Xbryk were simultaneously approved by the FDA in tandem with the EC approval of Obodence and Xbryk.3 In the United States, Ospomyv is indicated 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.
Xbryk is indicated for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors; 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.
In May 2024, the EC greenlit Wyost and Jubbonti as the first biosimilars referencing Xgeva and Prolia, respectively, approved in Europe.4
References
Accord Healthcare receives positive CHMP Opinion for denosumab, Osvyrti®, and Jubereq. News release. Accord. April 2, 2025. Accessed April 2, 2025. https://www.prnewswire.com/news-releases/accord-healthcare-receives-positive-chmp-opinion-for-denosumab-osvyrti-and-jubereq-302417524.html
Samsung Bioepis gains European Commission (EC) approval for denosumab biosimilar (Obodence, Xbryk). News release. Samsung Bioepis. February 16, 2025. Accessed April 2, 2025. https://www.samsungbioepis.com/en/newsroom/newsroomView.do?idx=436¤tPage=1
FDA approves Samsung Bioepis’ Ospomyv, Xbryk (denosumab-dssb), a biosimilar to Prolia and Xgeva. News release. Samsung Bioepis. February 16, 2025. Accessed April 2, 2025. https://www.samsungbioepis.com/en/newsroom/newsroomView.do?idx=435¤tPage=1
Sandoz receives European Commission approval for Wyost and Jubbonti, the first and only biosimilars of denosumab in Europe. News release. Sandoz. May 22, 2024. Accessed April 2, 2025. https://www.globenewswire.com/news-release/2024/05/22/2886160/0/en/Sandoz-receives-European-Commission-approval-for-Wyost-and-Jubbonti-the-first-and-only-biosimilars-of-denosumab-in-Europe.html