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更新于：2026-05-14
Denosumab-dssb
地舒单抗生物类似药 (Samsung Bioepis)
更新于：2026-05-14
概要
基本信息
非在研机构- |
最高研发阶段批准上市 |
首次获批日期 欧盟 (2025-02-12), |
最高研发阶段(中国)- |
特殊审评- |
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结构/序列
Sequence Code 94568L
当前序列信息引自: *****
Sequence Code 143522H
当前序列信息引自: *****
关联
2
项与 地舒单抗生物类似药 (Samsung Bioepis) 相关的临床试验NCT04664959
A Phase III, Randomised, Double-blind, Multicentre Clinical Study to Compare the Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity Between SB16 (Proposed Denosumab Biosimilar) and Prolia® in Postmenopausal Women With Osteoporosis
NCT04621318
A Randomised, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity of Denosumab (SB16, EU Sourced Prolia®, and US Sourced Prolia®) in Healthy Male Subjects
100 项与 地舒单抗生物类似药 (Samsung Bioepis) 相关的临床结果
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100 项与 地舒单抗生物类似药 (Samsung Bioepis) 相关的转化医学
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100 项与 地舒单抗生物类似药 (Samsung Bioepis) 相关的专利（医药）
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15
项与 地舒单抗生物类似药 (Samsung Bioepis) 相关的文献（医药）2025-12-01ANTONIE VAN LEEUWENHOEK INTERNATIONAL JOURNAL OF GENERAL AND MOLECULAR MICROBIOLOGY
Multifunctional lactic acid bacteria isolated from traditional Makdous
Article
作者: Koçan, Deniz ; Aydın, Furkan ; Kahve, Halil İbrahim
This study aimed to isolate and identify lactic acid bacteria from traditionally fermented Makdous, with a focus on selecting strains suitable for safe and functional fermentation. A total of 33 isolates were identified by 16S rRNA gene sequencing as Levilactobacillus brevis (n = 29) and Lactiplantibacillus plantarum (n = 4). Technological characterisation, comprising acidification, exopolysaccharide production, and tolerance to salt, acid, and acetic acid, was followed by multivariate analysis, which identified five promising strains: Lev. brevis SB4 and Lp. plantarum SB6, SB12, SB14, and SB16. These strains, alongside the reference Lacticaseibacillus rhamnosus GG, were further evaluated for in vitro probiotic properties. Among them, Lev. brevis SB4 and Lp. plantarum SB14 stood out due to high autoaggregation, surface hydrophobicity, antioxidant activity, and antimicrobial effects. Notably, Lp. plantarum SB14 showed the highest radical scavenging activity, while SB4 demonstrated potent inhibition against Listeria monocytogenes ATCC 13932 and Staphylococcus aureus ATCC 43300. These findings suggest that SB4 and SB14 are strong candidates as multifunctional starters to enhance the safety, quality, and health-promoting potential of fermented vegetable products and other functional food applications.
2025-05-19JOURNAL OF CLINICAL ENDOCRINOLOGY & METABOLISM
Proposed Denosumab Biosimilar SB16 vs Reference Denosumab in Postmenopausal Osteoporosis: Phase 3 Results Up to Month 12
Article
作者: Urboniene, Audrone ; Supronik, Jerzy ; Mordaka, Robert ; Rowińska-Osuch, Anna ; Dokoupilova, Eva ; Eastell, Richard ; Langdahl, Bente ; Rosa, Jan ; Plebanski, Rafal ; Rho, Young Hee ; Mydlak, Andrzej ; Chung, Yoon-Sok ; Baek, Ki-Hyun ; Ban, Jisuk ; Ahn, Sohui ; Czerwinski, Edward
Abstract:
Context:
SB16 is a proposed biosimilar to reference denosumab (DEN; brand name: Prolia).
Objective:
This phase 3 randomized, double-blind, multicenter study evaluated the biosimilarity of SB16 to DEN in women with postmenopausal osteoporosis (NCT04664959).
Design:
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.
Methods:
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.
Results:
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.
Conclusion:
The reported efficacy, pharmacokinetic, pharmacodynamic, safety, and immunogenicity data support the biosimilarity of SB16 to DEN.
2025-03-01BONE
SB16 versus reference denosumab in postmenopausal women with osteoporosis: 18-month outcomes of a phase III randomized clinical trial
Article
作者: Urboniene, Audrone ; Supronik, Jerzy ; Mordaka, Robert ; Baek, Ki-Hyun ; Eastell, Richard ; Dokoupilova, Eva ; Langdahl, Bente ; Rosa, Jan ; Plebanski, Rafal ; Rho, Young Hee ; Ahn, Sohui ; Mydlak, Andrzej ; Sapula, Rafal ; Chung, Yoon-Sok ; Rowińska-Osuch, Anna ; Ban, Jisuk ; Czerwinski, Edward
PURPOSE:
This study evaluated the efficacy, safety, pharmacodynamics (PD), pharmacokinetics (PK), and immunogenicity of SB16 versus reference denosumab (DEN) up to 18 months in postmenopausal osteoporosis (PMO) patients, and assessed outcomes after switching from DEN to SB16 compared to those who continued with DEN or SB16.
METHODS:
457 PMO patients were initially randomized, with 407 re-randomized at Month 12 to either continue DEN (DEN+DEN), switch to SB16 (DEN+SB16), or continue SB16 (SB16 + SB16) through Month 18. Efficacy was assessed by the percent change from baseline in bone mineral density (BMD) at the lumbar spine, total hip, and femoral neck. Safety, PD, PK, and immunogenicity were evaluated throughout the study period.
RESULTS:
Mean percent changes from baseline in lumbar spine, total hip, and femoral neck BMD at Month 18 were comparable across treatment groups, indicating comparable efficacy between SB16 and DEN. The mean percent change in lumbar spine BMD was 6.8 % (SB16 + SB16), 6.2 % (DEN+SB16), and 6.8 % (DEN+DEN). Total hip BMD increased by 4.4 %, 3.5 %, and 4.0 %, and femoral neck BMD by 3.4 %, 3.1 %, and 2.7 % for SB16 + SB16, DEN+SB16, and DEN+DEN, respectively. Safety profiles were similar among groups, with no new safety concerns identified after switching. Only one patient in the DEN+SB16 group developed non-neutralizing anti-drug antibodies by Month 18, indicating a low immunogenicity risk for SB16.
CONCLUSION:
Switching from DEN to SB16 demonstrated comparable efficacy, safety, PD, PK, and immunogenicity in PMO patients relative to those who continued DEN. SB16 was well tolerated over 18 months, demonstrating comparable outcomes to DEN.
36
项与 地舒单抗生物类似药 (Samsung Bioepis) 相关的新闻（医药）2026-05-13
2026-05-12
100 项与 地舒单抗生物类似药 (Samsung Bioepis) 相关的药物交易
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外链
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| - | - | - |
研发状态
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 代谢性骨病 | 澳大利亚 | 2025-07-09 | |
| 骨转移癌 | 韩国 | 2025-05-30 | |
| 恶性肿瘤体液性高钙血症 | 美国 | 2025-02-13 | |
| 骨骼病变 | 美国 | 2025-02-13 | |
| 骨癌 | 欧盟 | 2025-02-12 | |
| 骨癌 | 冰岛 | 2025-02-12 | |
| 骨癌 | 列支敦士登 | 2025-02-12 | |
| 骨癌 | 挪威 | 2025-02-12 | |
| 骨巨细胞瘤 | 欧盟 | 2025-02-12 | |
| 骨巨细胞瘤 | 冰岛 | 2025-02-12 | |
| 骨巨细胞瘤 | 列支敦士登 | 2025-02-12 | |
| 骨巨细胞瘤 | 挪威 | 2025-02-12 | |
| 糖皮质激素诱导的骨质疏松症 | 欧盟 | 2025-02-12 | |
| 糖皮质激素诱导的骨质疏松症 | 冰岛 | 2025-02-12 | |
| 糖皮质激素诱导的骨质疏松症 | 列支敦士登 | 2025-02-12 | |
| 糖皮质激素诱导的骨质疏松症 | 挪威 | 2025-02-12 | |
| 骨质疏松症 | 欧盟 | 2025-02-12 | |
| 骨质疏松症 | 冰岛 | 2025-02-12 | |
| 骨质疏松症 | 列支敦士登 | 2025-02-12 | |
| 骨质疏松症 | 挪威 | 2025-02-12 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床3期 | 457 | (SB16) | 遞艱顧顧餘願製餘廠鹽(夢鏇範鏇獵鹹糧積齋願) = 糧壓鑰構製齋鑰艱餘鬱 遞積願鏇廠願願選艱齋 (鏇艱獵選衊鑰壓構廠餘, 0.250) 更多 | - | 2025-01-09 | ||
(Prolia) | 遞艱顧顧餘願製餘廠鹽(夢鏇範鏇獵鹹糧積齋願) = 壓簾醖憲鹹鬱夢選鏇製 遞積願鏇廠願願選艱齋 (鏇艱獵選衊鑰壓構廠餘, 0.254) | ||||||
临床3期 | 457 | 鹽鏇齋夢蓋窪獵觸積繭(鏇淵淵繭觸廠製齋鏇襯) = 繭蓋選顧鑰觸遞糧襯齋 網衊窪範襯廠觸衊鏇築 (顧廠蓋築蓋鑰範鬱選蓋 ) | 相似 | 2024-09-07 | |||
鹽鏇齋夢蓋窪獵觸積繭(鏇淵淵繭觸廠製齋鏇襯) = 糧襯淵餘鬱齋獵糧艱繭 網衊窪範襯廠觸衊鏇築 (顧廠蓋築蓋鑰範鬱選蓋 ) | |||||||
临床3期 | 457 | 願願鹽獵簾製網鏇窪鏇(願簾膚遞憲鏇鬱鬱繭夢) = 繭窪顧鏇顧醖鹽範夢艱 餘鑰夢淵廠網獵繭衊積 (願鏇醖鏇網簾願衊鏇選 ) | 相似 | 2024-06-14 | |||
- | |||||||
临床3期 | 457 | 願糧積衊膚範艱繭製醖(衊淵願窪憲積製選鑰繭) = 製遞齋遞築顧膚構衊齋 網顧憲淵獵築艱艱願遞 (淵夢淵壓築鏇鏇鬱獵壓 ) 更多 | 积极 | 2023-11-04 | |||
願糧積衊膚範艱繭製醖(衊淵願窪憲積製選鑰繭) = 餘積鏇觸糧鬱餘餘觸獵 網顧憲淵獵築艱艱願遞 (淵夢淵壓築鏇鏇鬱獵壓 ) 更多 |
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