On 17 April 2026, Samsung Bioepis announced new clinical data reinforcing the efficacy of its denosumab biosimilar, SB16 (Obodence®, referred to in the US as Ospomyv®), and highlighting consistent outcomes across diverse patient subgroups. The findings were presented at the World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (WCO-IOF-ESCEO) held in Prague from 16-19 April 2026.
The data results from a Phase 3 clinical trial of SB16 involving 456 postmenopausal women with osteoporosis. The subgroup analysis assessed the consistency of treatment effects across key patient characteristics, including age, body mass index, prior oral bisphosphonate use, smoking status, and presence of vertebral fractures.
SB16 demonstrated comparable efficacy to the reference product (Amgen’s Prolia® (denosumab)) across all evaluated subgroups. According to Samsung Bioepis, the results further strengthen the “totality of evidence” supporting SB16’s biosimilarity.
Samsung Bioepis’ Ospomyv® was the second Prolia® biosimilar approved in the US (in February 2025) and was scheduled to be offered on US formularies from 1 April 2026. BPCIA litigation commenced by Amgen alleging that Samsung Bioepis’ denosumab biosimilars infringed 36 US patents relating to denosumab was settled in September 2025. Samsung Bioepis’ denosumab biosimilars have also been approved elsewhere, including Europe (February 2025, Obodence® launched from December 2025), Korea (Obodence® launched July 2025), and Australia (July 2025, not yet launched).