Incheon, Korea, Dec 02, 2025— Samsung Bioepis Co., Ltd. today announced the launch of OBODENCE™ (60 mg pre-filled syringe) and XBRYK™ (120 mg vial), denosumab biosimilars referencing Prolia and Xgeva. The products will be commercially available in Europe in December 2025 and January 2026, respectively.
“We are very thrilled to launch OBODENCE and XBRYK through our direct sales efforts. Osteoporosis remains a major challenge in Europe due to limited treatment options and affordability challenges. And bone-related events resulting from bone metastases significantly impact a patient’s quality of life, leading to death if not treated fast enough. 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. “With our proven track records, we’re confident that OBODENCE and XBRYK will deliver meaningful impact on patients and their communities.”
OBODENCE, referencing Prolia, has been approved 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, referencing Xgeva, has been approved for the prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with advanced malignancies involving bone, and treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity.
In Europe alone, osteoporosis results in 4.3 million fragility fractures and health care costs reaching €56 billion annually. Due to the limited treatment options and affordability of the medications, less than half of women at high risk of fracture are treated.1 In addition, skeletal related events (SREs) resulting from bone metastases can lead to severe pain, increased risk of death, increased health care costs and reduced quality of life.2
OBODENCE, the company’s first biosimilar in endocrinology, and XBRYK, the company’s third biosimilar in oncology, mark Samsung Bioepis’ 10th and 11th biosimilars available in Europe. They add to the company’s diverse therapeutic portfolio ranging from immunology, oncology, ophthalmology, hematology, and nephrology.