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Samsung Bioepis Co., Ltd. announced new data supporting the consistent efficacy of SB16 (OBODENCE®), its biosimilar to Prolia (denosumab), across patient subgroups compared with reference denosumab. The findings will be presented as a poster at the World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (WCO-IOF-ESCEO) 2026 in Prague from April 16 to 19.
Consistent efficacy across patient subgroups is described as important for reinforcing physician confidence and improving treatment accessibility for patients with osteoporosis. Jeehoon Ghil, Vice President and Medical & Lifecycle Safety Team Leader at Samsung Bioepis, said the data contribute to the robustness of the overall biosimilarity assessment and support clinical confidence in the denosumab biosimilar.
SB16 was evaluated in a randomized, double-blind, multicenter Phase 3 clinical trial that enrolled 456 postmenopausal women with osteoporosis. Participants were assigned to receive either SB16 or reference denosumab.
The subgroup analysis assessed consistency of treatment effects across key demographic and baseline disease characteristics, including:
Efficacy was measured as the percent change from baseline in bone mineral density at the lumbar spine, total hip, and femoral neck at month 12. Comparative analyses between treatment groups used established statistical methods, including analysis of covariance (ANCOVA), to evaluate consistency across subgroups.
The company said the results demonstrated that SB16 showed consistent efficacy to reference denosumab across all evaluating subgroups, further supporting the overall biosimilarity of SB16.
Established in 2012, Samsung Bioepis is a biopharmaceutical company focused on making healthcare accessible. It is a wholly owned subsidiary of Samsung Epis Holdings and is advancing a broad pipeline of biologic candidates across therapeutic areas including immunology, oncology, ophthalmology, hematology, nephrology, and endocrinology.
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