A Study to Compare SB16 (Proposed Denosumab Biosimilar) to Prolia® in Postmenopausal Women With Osteoporosis

Phase 3 Completed 457 enrolled Samsung Bioepis Co., Ltd.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a randomised, double-blind, multicentre study to evaluate the efficacy, safety, PK, PD, and immunogenicity of SB16 compared to Prolia® in postmenopausal women with osteoporosis.

Timeline

Start: 2020-11-26
Primary completion: 2022-06-20
Completion: 2023-01-03

Outcome

Met primary endpoint

paper both within the predefined equivalence margin. PMID 39243386 ↗

release “SB16과 오리지널 의약품 간 차이는 사전에 정의한 동등성 기준4)을 만족하여 두 그룹 간 효능이 동등한 것으로 확인됐다.” samsungbioepis.com ↗

Publications

Langdahl B, Chung YS, Plebanski R, Czerwinski E, Dokoupilova E, Supronik J, Rosa J, Mydlak A, Rowinska-Osuch A, Baek KH, Urboniene A, Mordaka R, Ahn S, Rho YH, Ban J, Eastell R. Proposed Denosumab Biosimilar SB16 vs Reference Denosumab in Postmenopausal Osteoporosis: Phase 3 Results Up to Month 12. J Clin Endocrinol Metab. 2025 May 19;110(6):e1951-e1958. doi: 10.1210/clinem/dgae611.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Denosumab	Monoclonal antibody	60 mg	Subcutaneous
Subject	SB16	Unknown	60 mg	Subcutaneous