Langdahl Bente, Chung Yoon-Sok, Plebanski Rafal, Czerwinski Edward, Dokoupilova Eva, Supronik Jerzy, Rosa Jan, Mydlak Andrzej, Rowińska-Osuch Anna, Baek Ki-Hyun, Urboniene Audrone, Mordaka Robert, Ahn Sohui, Rho Young Hee, Ban Jisuk, Eastell Richard
Department of Endocrinology, Aarhus University Hospital and Department of Clinical Medicine, Aarhus University, Aarhus, 8200, Denmark.
Department of Endocrinology and Metabolism, Ajou University School of Medicine, Suwon, 16499, Republic of Korea.
J Clin Endocrinol Metab. 2025 May 19;110(6):e1951-e1958. doi: 10.1210/clinem/dgae611.
SB16 is a proposed biosimilar to reference denosumab (DEN; brand name: Prolia).
This phase 3 randomized, double-blind, multicenter study evaluated the biosimilarity of SB16 to DEN in women with postmenopausal osteoporosis (NCT04664959).
The study included 457 postmenopausal osteoporosis patients who had a lumbar spine or total hip T-score between -2.5 and -4. Patients were randomized in a 1:1 ratio to receive either 60 mg of SB16 or DEN subcutaneously at month 0 and month 6. At month 12, patients were rerandomized to continue with the assigned treatment or switch from DEN to SB16 up to month 18. This report includes results up to month 12.
The primary endpoint was the percent change from baseline in lumbar spine bone mineral density (BMD) at month 12. Secondary endpoints including the percent change from baseline in BMD of the lumbar spine (except for month 12), total hip, and femoral neck; pharmacokinetic, pharmacodynamic (serum C-telopeptide of type I collagen, and procollagen type I N-terminal propeptide), safety, and immunogenicity profiles were measured up to month 12.
The least-squares mean differences in percent change from baseline in lumbar spine BMD at month 12 were 0.33% (90% CI, -0.25 to 0.91) in the full analysis set and 0.39% (95% CI, -0.36 to 1.13) in the per-protocol set; both within the predefined equivalence margin. The secondary endpoints were comparable between the 2 treatment groups.
The reported efficacy, pharmacokinetic, pharmacodynamic, safety, and immunogenicity data support the biosimilarity of SB16 to DEN.
SB16是一种拟与对照药地诺单抗（DEN；商品名：Prolia）相似的生物药。
这项3期随机、双盲、多中心研究评估了SB16与DEN在绝经后骨质疏松症女性中的生物相似性（NCT04664959）。
该研究纳入了457名腰椎或全髋部T值在-2.5至-4之间的绝经后骨质疏松症患者。患者按1:1比例随机分组，在第0个月和第6个月皮下注射60mg SB16或DEN。在第12个月时，患者重新随机分组，继续接受指定治疗或从DEN转换为SB16，直至第18个月。本报告包括截至第12个月的结果。
主要终点是第12个月时腰椎骨矿物质密度（BMD）相对于基线的变化百分比。次要终点包括腰椎（第12个月除外）、全髋部和股骨颈BMD相对于基线的变化百分比；在第12个月时测量了药代动力学、药效学（I型胶原血清C端肽和I型前胶原N端前肽）、安全性和免疫原性特征。
在全分析集和符合方案集中，第12个月时腰椎BMD相对于基线变化百分比的最小二乘均值差异分别为0.33%（90%CI，-0.25至0.91）和0.39%（95%CI，-0.36至1.13）；均在预定义的等效范围内。两个治疗组的次要终点具有可比性。
报告的疗效、药代动力学、药效学、安全性和免疫原性数据支持SB16与DEN的生物相似性。
