
Samsung Bioepis announces launch of two new denosumab biosimilars in Europe
Esme Needham | December 4, 2025 | News story | Sales and Marketing | Oncology, Osteoporosis, Samsung Bioepis
Samsung Bioepis has announced the European launch of Obodence and Xbryk, two new denosumab biosimilars approved for the treatment of bone disease.
Obodence, referencing Amgen’s Prolia, has been approved for the treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures, as well as for bone loss associated with prostate cancer and long-term systemic glucocorticoid therapy. Xbryk, referencing Amgen’s Xgeva, has been approved for the prevention of skeletal-related events (SREs) in adults with advanced malignancies involving bone, and treatment of adults and skeletally mature adolescents with unresectable giant cell tumour of bone.
Osteoporosis results in 4.3 million fragility fractures in Europe annually, leading to a yearly healthcare cost of 56bn euros. SREs resulting from bone metastases can cause severe pain and fatality, as well as high healthcare costs, and there is an increasingly urgent need for innovative, affordable therapies for bone disease.
“Our biosimilars aim to improve access, enable timely care and ease the financial burden on healthcare systems,” said Linda Choi MacDonald, executive vice president and global head of commercial division at Samsung Bioepis.
Samsung Bioepis is a biopharmaceutical company with a broad portfolio of biosimilar products. Obodence is its first endocrinology biosimilar, while Xbryk is its third oncology biosimilar.
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