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更新于：2026-04-15
Ustekinumab-ttwe
乌司奴单抗生物类似药（Samsung Bioepis）
更新于：2026-04-15
概要
基本信息
非在研机构- |
最高研发阶段批准上市 |
最高研发阶段(中国)- |
特殊审评- |
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结构/序列
Sequence Code 143665H
当前序列信息引自: *****
Sequence Code 143874L
当前序列信息引自: *****
关联
2
项与 乌司奴单抗生物类似药（Samsung Bioepis） 相关的临床试验NCT04967508
A Phase III, Randomised, Double-blind, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Immunogenicity of SB17 (Proposed Ustekinumab Biosimilar) Compared to Stelara® in Subjects With Moderate to Severe Plaque Psoriasis
NCT04772274
A Randomised, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Ustekinumab (SB17, EU Sourced Stelara®, and US Sourced Stelara®) in Healthy Subjects
100 项与 乌司奴单抗生物类似药（Samsung Bioepis） 相关的临床结果
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100 项与 乌司奴单抗生物类似药（Samsung Bioepis） 相关的转化医学
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100 项与 乌司奴单抗生物类似药（Samsung Bioepis） 相关的专利（医药）
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8
项与 乌司奴单抗生物类似药（Samsung Bioepis） 相关的文献（医药）2026-03-20ORGANIC LETTERS
Talamangins A–C, Immunosuppressive and Anti-inflammatory Nitrogenated Azaphilone Hybrids from
Talaromyces mangshanicus
SB17
Article
作者: Zhou, Ting ; Sun, Yi-Kai ; Li, Wan-Peng ; Zhou, Yin-Hui ; Ruan, Han-Li ; Yu, Xiao-Kun ; Qin, Chun-Lun
Three unprecedented nitrogenated azaphilone hybrids, talamangins A-C (1-3), were isolated from the endophytic fungus Talaromyces mangshanicus SB17. Their structures, along with their absolute configurations, were determined by extensive spectroscopic data analysis and single-crystal X-ray diffraction. Compounds 1-3 represent the first examples of nitrogenated azaphilone hybrids, distinguished by a novel fused scaffold formed through the angular fusion of nitrogenated azaphilone and a benzophenone unit, with the azaphilone fragment featuring a pyridine ring. Plausible biosynthetic pathways for 1-3 are proposed. Compounds 1-3 exhibit potent immunosuppressive activities against concanavalin A (ConA)-induced T cell proliferation, with IC50 values of 13.0, 14.3, and 24.1 μM, respectively, as well as against lipopolysaccharide (LPS)-induced B cell proliferation, with IC50 values of 14.5, 18.5, and 19.2 μM, respectively. Additionally, compounds 1-3 inhibit nitric oxide production in LPS-induced RAW264.7 cells, with IC50 values of 6.2, 9.4, and 10.5 μM, respectively.
2025-06-03EXPERT OPINION ON BIOLOGICAL THERAPY
The ‘totality of evidence’ and ‘extrapolation’ of SB17, a ustekinumab biosimilar
Review
作者: Girolomoni, Giampiero ; Duk Ye, Byong ; Jung, Hojung ; Armuzzi, Alessandro ; Feldman, Steven R. ; Rieder, Florian ; Puig, Luis ; Cheon, Jae Hee
INTRODUCTION:
SB17 is a ustekinumab (UST) biosimilar targeting interleukin-12/23 for treating immune-mediated inflammatory diseases (IMIDs). The development of UST biosimilars like SB17 may help address the high cost of innovator biologics, offering affordable alternatives without compromising efficacy or safety.
AREAS COVERED:
This review encompasses the totality of evidence supporting SB17's similarity to UST, its regulatory approval, and indication extrapolation. It also discusses SB17's lower immunogenicity relative to UST.
EXPERT OPINION:
The approval of UST biosimilars represents a significant advancement in managing chronic IMIDs including psoriasis, plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis, providing cost-effective, efficacious alternatives. A randomized double-blind 28-week study involving over 500 patients with moderate-to-severe chronic plaque psoriasis demonstrated SB17's equivalence to UST, with more than 80% of patients achieving over 90% improvement in psoriasis severity indices. Treatment-emergent adverse events were comparable between SB17 and UST. Despite their potential to transform clinical outcomes, economic burdens, and drug utilization patterns, the adoption of UST biosimilars faces challenges, including concerns about equivalence and regulatory inconsistencies. Addressing these issues through education, consistent regulatory frameworks, real-world data, and ongoing monitoring is crucial for their successful integration into clinical practice.
2025-03-01DRUGS IN R&D
Characterization for the Similarity Assessment Between the Proposed Biosimilar SB17 and Ustekinumab Reference Product Using State-of-the-Art Analytical Methods
Article
作者: Lee, Jungmin ; Lee, Jaell ; Hong, Juyong ; Jung, Seongyoung ; Lee, Changsoo ; Hwang, Keumbi ; Yang, Sung-Yong
BACKGROUND:
SB17 is being developed as a biosimilar to ustekinumab reference product (RP), a human monoclonal antibody (IgG1 kappa immunoglobulin) that binds to the common p40 subunit of cytokines interleukin (IL)-23 and IL-12. Binding to this subunit prevents interaction with their receptor, resulting in modulation in the immune system responses that play a key role in inflammatory disease.
OBJECTIVE:
The objective of this study was to demonstrate structural, physicochemical, and biological similarity between ustekinumab RP and SB17 using various state-of-the-art analytical methods.
METHODS:
Comprehensive analytical characterization was conducted by the quality range and side-by-side comparison approach for SB17 versus the European Union (EU) and US ustekinumab RP using various analytical methods. Comparisons included purity, product-related impurity, charge heterogeneity, primary structure, posttranslational modification, higher-order structure, quantity, Fab-related biological activities (potency and binding activity), and Fc-related biological activities.
RESULTS:
On the basis of the analytical similarity assessment, the structural, physicochemical, and biological characterization results demonstrated that SB17 is comparable to the ustekinumab RP. In the structural aspects, it was confirmed that there is no clinically meaningful difference between posttranslational modification profiles and higher-order structures of SB17 compared with the ustekinumab RP. Product-related impurities in the form of aggregates were also confirmed to be similar. SB17 has lower acidic and basic variants compared with ustekinumab RP, owing to the difference in the producing cell line. Ustekinumab RP is expressed in an Sp2/0 cell line, whereas SB17 is expressed in CHO cell line. However, the difference between SB17 and ustekinumab RP in the charge variants is not considered to be clinically meaningful, since equivalent biological activity was observed. In the case of mechanism of action (MoA)-related biological activities, SB17 is highly similar to the EU and US ustekinumab RP with respect to overall critical and noncritical quality attributes analyzed. Moreover, similarity or lack of activity in Fc-related biological activities was also confirmed. On the basis of these results, SB17 is expected to have comparable safety and efficacy as compared with ustekinumab RP.
CONCLUSION:
In summary, the overall analytical characterization and similarity assessment results show that SB17 is comparable to the EU and US ustekinumab RP in terms of structural, physicochemical, biophysical, and biological attributes.
100 项与 乌司奴单抗生物类似药（Samsung Bioepis） 相关的药物交易
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外链
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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 |
|---|---|---|---|
| 银屑病关节炎 | 欧盟 | 2024-04-19 | |
| 银屑病关节炎 | 冰岛 | 2024-04-19 | |
| 银屑病关节炎 | 列支敦士登 | 2024-04-19 | |
| 银屑病关节炎 | 挪威 | 2024-04-19 | |
| 活动性中度克罗恩病 | 欧盟 | 2024-04-19 | |
| 活动性中度克罗恩病 | 冰岛 | 2024-04-19 | |
| 活动性中度克罗恩病 | 列支敦士登 | 2024-04-19 | |
| 活动性中度克罗恩病 | 挪威 | 2024-04-19 | |
| 活动性重度克罗恩病 | 欧盟 | 2024-04-19 | |
| 活动性重度克罗恩病 | 冰岛 | 2024-04-19 | |
| 活动性重度克罗恩病 | 列支敦士登 | 2024-04-19 | |
| 活动性重度克罗恩病 | 挪威 | 2024-04-19 | |
| 斑块状银屑病 | 欧盟 | 2024-04-19 | |
| 斑块状银屑病 | 冰岛 | 2024-04-19 | |
| 斑块状银屑病 | 列支敦士登 | 2024-04-19 | |
| 斑块状银屑病 | 挪威 | 2024-04-19 | |
| 活动性中度溃疡性结肠炎 | 欧盟 | 2024-04-19 | |
| 活动性中度溃疡性结肠炎 | 冰岛 | 2024-04-19 | |
| 活动性中度溃疡性结肠炎 | 列支敦士登 | 2024-04-19 | |
| 活动性中度溃疡性结肠炎 | 挪威 | 2024-04-19 |
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临床结果
临床结果
适应症
分期
评价
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临床3期 | 503 | 餘衊衊餘積顧願鏇壓衊(簾艱鹽鑰餘膚積齋鹽鏇) = 構簾鏇鏇構願獵獵醖願 鬱餘憲衊築鬱築壓廠糧 (夢構憲糧艱淵遞蓋蓋觸, 2.53) 更多 | - | 2025-05-25 | |||
临床3期 | 481 | 鬱簾齋蓋築顧醖窪選糧(窪鹽壓獵齋顧餘淵蓋築) = 鹹願壓廠憲顧醖繭鹹醖 艱築憲構構築夢鑰淵網 (願壓獵淵醖網願鏇壓構 ) 更多 | 相似 | 2024-03-08 | |||
鬱簾齋蓋築顧醖窪選糧(窪鹽壓獵齋顧餘淵蓋築) = 鹹憲鏇壓窪鹹鬱齋齋淵 艱築憲構構築夢鑰淵網 (願壓獵淵醖網願鏇壓構 ) 更多 | |||||||
临床3期 | - | 簾衊鹽廠齋餘窪網襯製(積鹹簾廠選鬱蓋衊憲遞): Difference = -0.6 (95% CI, −3.780 ~ 2.579) 达到 | 积极 | 2023-10-11 | |||
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