Two Samsung Bioepis Biosimilars Approved by Both FDA and EC
Ospomyv, or Obodence in the EU, and Xbryk were approved for all indications referencing Prolia and Xgeva, respectively.
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In two separate announcements on Feb. 16, 2025, Samsung Bioepis, headquartered in Incheon, South Korea, said two of its denosumab biosimilars, referencing the brand names Prolia and Xgeva, have been approved by both FDA and the European Commission (EC) (1,2).
The medication known as Ospomyv in the United States and Obodence in Europe (denosumab-dssb, 60 mg prefilled syringe), which references Prolia, was approved for several treatments, all the same indications as Prolia: of postmenopausal women with osteoporosis, to increase bone mass in men with osteoporosis or who are receiving androgen deprivation therapy for nonmetastatic prostate cancer, of glucocorticoid-induced osteoporosis in both men and women, and to increase bone mass in women receiving adjuvant aromatase inhibitor therapy for breast cancer—specifically for those with such diagnoses who are at high risk of fracture (1).
Xbryk (denosumab-dssb, 120 mg vial), referencing Xgeva, has been approved for prevention of skeletal-related events, according to Samsung Bioepis, in patients with multiple myeloma or who have bone metastases from solid tumors, as well as treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or for which surgical resection may result in severe morbidity, and for treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy (1).
“The FDA approval of Ospomyv and Xbryk marks a key step in improving patient access and alleviating treatment cost for patients with osteoporosis and cancer-related bone loss in the US,” Byoungin Jung, vice president and regulatory affairs team leader at Samsung Bioepis, said in a company press release (1). “By providing quality-proven biosimilars, we are helping to address a critical healthcare need and reduce the burden of skeletal fractures that impact patients’ quality of life.”
Ospomyv/Obodence and Xbryk had previously been referred to as SB16, according to Samsung Bioepis (2).
“With this approval for a biosimilar, a cost-effective treatment option with equal clinical effectiveness and safety compared to the reference medicine, we are making an important progress towards enhancing access to an effective treatment option for patients with osteoporosis and cancer-related bone loss which can lead to skeletal fractures, seriously affecting the quality of life of patients,” Jung said in the release announcing the EC approvals (2).
Samsung Bioepis characterized osteoporosis as a “major concern” in Europe, sharing statistics such as annual healthcare costs in excess of €56 billion (US$58.3 billion) to cover an estimated 4.3 million fragility fractures (2). The company said that less than half of high-risk women are treated, despite affordable medications being available.
Still, there exists a demand for biosimilars for these symptoms and treatments. In the January–February 2025 issue of BioPharm International®, Joe Compton, senior director of Business Development and Alliance Management for TPU, or Tjoapack US, referenced Samsung Bioepis’ September 2024 edition of its Biosimilar Market Dynamics publication while reviewing current and future market trends in biologics packaging (3).
“The biosimilar market in the United States has experienced rapid growth, with 61 biosimilars approved across 17 unique biological molecules by September 2024, and the global biosimilar market is estimated to reach $43.8 billion by the end of 2024,” Compton wrote (3).
The decisions by both FDA and EC marked Samsung Bioepis’ first approval for an endocrinology biosimilar by either regulatory body, according to the respective press releases (1,2).
References
1. Samsung Bioepis. FDA Approves Samsung Bioepis’ Ospomyv, Xbryk (denosumab-dssb), a Biosimilar to Prolia and Xgeva. Press Release. Feb. 16, 2025.
2. Samsung Bioepis. Samsung Bioepis Gains European Commission (EC) Approval for Denosumab Biosimilar (Obodence, Xbryk). Press Release. Feb. 16, 2025.
3. Compton, J. Meeting Secondary Packaging Challenges of Innovative Delivery Systems for Biologics. BioPharm International 2025, 38 (1), 21–24.
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