Samsung Bioepis Highlights Consistent Efficacy of SB16 (OBODENCE®; Denosumab) Across Osteoporosis Patient Subgroups at WCO-IOF-ESCEO 2026

- Subgroup analysis from Phase 3 study demonstrates consistent efficacy of SB16 across key patient populations
- Results reinforce the totality-of-evidence supporting SB16 biosimilarity

INCHEON, Korea--(BUSINESS WIRE)--Samsung Bioepis Co., Ltd. announced today new data supporting consistent efficacy of SB16 (OBODENCE^®1), a biosimilar to Prolia² (denosumab) across patient subgroups compared to the reference denosumab. The data will be presented as a poster presentation 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 critical in reinforcing physician confidence and advancing treatment accessibility for patients with osteoporosis,” said Jeehoon Ghil, Vice President and Medical & Lifecycle Safety Team Leader at Samsung Bioepis. “Such data contribute to the robustness of the overall biosimilarity assessment and support the clinical confidence in our denosumab biosimilar.”

SB16 was evaluated in a randomized, double-blind, multicenter Phase 3 clinical trial involving 456 postmenopausal women with osteoporosis, who were assigned to receive either SB16 or reference denosumab³. This subgroup analysis assessed the consistency of treatment effects across key demographic and baseline disease characteristics, including age, body mass index, prior oral bisphosphonate use, smoking status, and presence of vertebral fractures. Efficacy was measured by 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 were conducted using established statistical methods, including analysis of covariance (ANCOVA), to evaluate consistency across subgroups. The results demonstrated that SB16 showed consistent efficacy to reference denosumab across all evaluating subgroups, further supporting the overall biosimilarity of SB16.

Poster presentation details:

- Title: Efficacy Consistency of SB16 to Reference Denosumab in Postmenopausal Women with Osteoporosis: Subgroup Analysis by Demographic and Baseline Disease Characteristics of a Randomized Phase III Clinical Trial
- Authors: Richard Eastell, Yumie Rhee, Núria Guañabens, Peyman Hadji, Jihyun Han, Jieun Yeom, SoHui Ahn, Dukyoung Youn, Bente Langdahl
- Abstract number: P338
- Date & Time: Friday April 17, 2026: 08:30 – 16:00
- Location: O2 universum Prague

About Samsung Bioepis Co., Ltd.

Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. As a wholly owned subsidiary of Samsung Epis Holdings, Samsung Bioepis continues to advance a broad pipeline of biologic candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, endocrinology. For more information, please visit www.samsungbioepis.com and follow us on LinkedIn and X.

References

¹ OBODENCE is a trademark of Samsung Bioepis Co., Ltd. also referred to as OSPOMYV in the United States
² Prolia is a trademark of Amgen.
³ Langdahl B et al. J Clin Endocrinol Metab. 2025;110(6): e1951-e1958.