Samsung Bioepis Co. is about to launch OBODENCE (60 mg pre-filled syringe) and XBRYK (120 mg vial), denosumab biosimilars referencing Prolia and Xgeva, the corporate introduced on Dec. 1. The merchandise will likely be commercially out there in Europe in December 2025 and January 2026, respectively.
“We’re very thrilled to launch OBODENCE and XBRYK by way of our direct gross sales efforts. Osteoporosis stays a serious problem in Europe as a result of restricted therapy choices and affordability challenges. And bone-related occasions ensuing from bone metastases considerably influence a affected person’s high quality of life, resulting in loss of life if not handled quick sufficient. Our biosimilars goal to enhance entry, allow well timed care, and ease the monetary burden on healthcare methods,” stated Linda Choi MacDonald, govt vp and world head of the Business Division at Samsung Bioepis. “With our confirmed monitor information, we’re assured that OBODENCE and XBRYK will ship significant influence on sufferers and their communities.”
OBODENCE, referencing Prolia, has been authorized for the therapy of osteoporosis in postmenopausal ladies and in males at elevated danger of fractures, therapy of bone loss related to hormone ablation in males with prostate most cancers at elevated danger of fractures, and therapy of bone loss related to long-term systemic glucocorticoid remedy in grownup sufferers at elevated danger of fracture.
XBRYK, referencing Xgeva, has been authorized for the prevention of skeletal associated occasions (pathological fracture, radiation to bone, spinal twine compression or surgical procedure to bone) in adults with superior malignancies involving bone, and therapy of adults and skeletally mature adolescents with big cell tumour of bone that’s unresectable or the place surgical resection is more likely to lead to extreme morbidity.
In Europe alone, osteoporosis ends in 4.3 million fragility fractures and well being care prices reaching €56 billion yearly. As a result of restricted therapy choices and affordability of the medicines, lower than half of girls at excessive danger of fracture are handled. As well as, skeletal associated occasions (SREs) ensuing from bone metastases can result in extreme ache, elevated danger of loss of life, elevated well being care prices and diminished high quality of life.
OBODENCE, the corporate’s first biosimilar in endocrinology, and XBRYK, the corporate’s third biosimilar in oncology, mark Samsung Bioepis’ tenth and eleventh biosimilars out there in Europe. They add to the corporate’s numerous therapeutic portfolio starting from immunology, oncology, ophthalmology, hematology, and nephrology.
