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Samsung Bioepis Switching Studies For Denosumab Confirm Safety & Efficacy

May 27, 2024

On 27 May 2024, Samsung Bioepis presented follow-up results from a Phase 3 study on SB16, biosimilar to Amgen’s Prolia® (denosumab).  According to Samsung Bioepis, the study demonstrated that switching postmenopausal osteoporosis patients from Prolia® to SB16 produced comparable results up to 18 months in terms of efficacy, safety and immunogenicity.  The results were presented at the 2024 European Calcified Tissue Society (ECTS) Congress in France. 

12-month results from the Phase 3 study were previously presented at the American Society for Bone and Mineral Research (ASBMR) Annual Meeting in October 2023. 

Denosumab biosimilars have been approved in the US and EU (Sandoz’s Jubbonti® and Wyost®) and in China (Boan Biotech’s Byoubei® and Boluojia® and Mabwell’s Mailishu® and MaiweijianTM).