Samsung Bioepis is set to launch OBODENCE™ (60 mg pre-filled syringe) and XBRYK™ (120 mg vial). These products are denosumab biosimilars from Prolia and Xgeva. They will be available in Europe starting December 2025 and January 2026. “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.
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OBODENCE is approved for treating osteoporosis in postmenopausal women and men at high fracture risk, as well as bone loss associated with hormone ablation in prostate cancer and long-term glucocorticoid therapy. XBRYK is approved for preventing skeletal-related events in adults with advanced bone-involved malignancies and for treating giant cell tumour of bone. With osteoporosis causing 4.3 million fractures and €56 billion in annual healthcare costs in Europe, and skeletal-related events significantly reducing quality of life, the introduction of OBODENCE and XBRYK marks a meaningful expansion of Samsung Bioepis’ European portfolio, bringing its total to 11 biosimilars across key therapeutic areas.