Samsung Bioepis has 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," said Linda Choi MacDonald, Executive Vice President and Global Head of Commercial Division at Samsung Bioepis.
"Osteoporosis remains a major challenge in Europe due to limited treatment options and affordability challenges."
"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."
“With our proven track records, we’re confident that OBODENCE and XBRYK will deliver meaningful impact on patients and their communities.”
OBODENCE (referencing Prolia) is approved for treating osteoporosis in postmenopausal women and men at increased fracture risk, bone loss from hormone ablation in prostate cancer and bone loss from long-term systemic glucocorticoid therapy in adults.
XBRYK (referencing Xgeva) is approved to prevent skeletal-related events in adults with advanced bone-involving malignancies and to treat unresectable or high-morbidity giant cell tumours of bone in adults and skeletally mature adolescents.
In Europe alone, osteoporosis results in 4.3 million fragility fractures and health care costs reaching €56bn annually.
Due to the limited treatment options and affordability of the medications, less than half of women at high risk of fracture are treated.
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.
OBODENCE, the company’s first biosimilar in endocrinology and XBRYK, the company’s third biosimilar in oncology, mark Samsung Bioepis’ tenth and eleventh biosimilars available in Europe.
They add to the company’s diverse therapeutic portfolio, ranging from immunology, oncology, ophthalmology, haematology and nephrology.