Denosumab

INCHEON, Korea--(BUSINESS WIRE)--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. With our proven track records, we’re confident that OBODENCE and XBRYK will deliver meaningful impact on patients and their communities. “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. About OBODENCE (denosumab) in the European Union Obodence 60 mg solution for injection in pre-filled syringe is indicated for the treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women denosumab significantly reduces the risk of vertebral, non-vertebral and hip fractures. Treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures. In men with prostate cancer receiving hormone ablation, denosumab significantly reduces the risk of vertebral fractures. Treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture. OBODENCE EU Important Safety Information The EU Summary of Product Characteristics for OBODENCE includes the following Special warning and Precautions: Hypersensitivity Hypocalcaemia Renal impairment Skin infections Osteonecrosis of the jaw (ONJ) Osteonecrosis of the external auditory canal Atypical fractures of the femur Long-term antiresorptive treatment Concomitant treatment with other denosumab-containing medicinal products Hypercalcaemia in paediatric patients These highlights do not include all the information needed to use OBODENCE safely and effectively. Refer to the Summary of Product Characteristics for OBODENCE’s full safety information. About XBRYK (denosumab) in the European Union Xbryk 120 mg solution for injection is indicated 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. 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. XBRYK EU Important Safety Information The EU Summary of Product Characteristics for XBRYK includes the following Special warning and Precautions: Hypersensitivity Hypocalcaemia Hypercalcaemia following treatment discontinuation in patients with giant cell tumour of bone and in patients with growing skeletons Renal impairment Osteonecrosis of the jaw (ONJ) Osteonecrosis of the external auditory canal Atypical fractures of the femur These highlights do not include all the information needed to use XBRYK safely and effectively. Refer to the Summary of Product Characteristics for XBRYK’s full safety information. # # # About Samsung Bioepis Co., Ltd. Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, and endocrinology. For more information, please visit: www.samsungbioepis.com and follow us on social media – X, LinkedIn. 1 International Osteoporosis Foundation. SCORECARD FOR OSTEOPOROSIS IN EUROPE: SCOPE 2021 Summary Report. Available at: https://www.osteoporosis.foundation/scope-2021. Accessed January 2025. 2 So A, Chin J, Fleshner N, Saad F. Management of skeletal-related events in patients with advanced prostate cancer and bone metastases: Incorporating new agents into clinical practice. Can Urol Assoc J. 2012 Dec;6(6):465-70. doi: 10.5489/cuaj.12149. PMID: 23282666; PMCID: PMC3526633.

Fresenius announced today the launch of its denosumab biosimilars, Conexxence® 1 (denosumab) and Bomyntra® 2 (denosumab), in Europe. These biosimilars received approval from the European Commission in July 2025 for all indications of the reference products Prolia® 3 (denosumab) and Xgeva® 4 (denosumab), respectively. “Being the first biosimilar company with a pre-filled syringe for the denosumab oncology indication in Europe, showcases our commitment to offering new treatment options that support patient care and affordability across Europe,” said Dr. Sang Jin Pak, President Biopharma. This milestone marks the next step in the company’s ambition to drive accessibility to high-quality biosimilar therapies, with multiple molecules in early and late-stage development. By continuing its successful track record in the biosimilars space, Fresenius further strengthens its (Bio)Pharma platform, a key pillar of the #FutureFresenius strategy. 1. Conexxence® is a registered trademark of Fresenius Kabi Deutschland GmbH in selected countries. 2. Bomyntra® is a registered trademark of Fresenius Kabi Deutschland GmbH in selected countries. 3. Prolia® is a registered trademarks of Amgen Inc. 4. Xgeva® is a registered trademarks of Amgen Inc.