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更新于：2026-09-08
Infliximab-dyyb (Celltrion)
英夫利西单抗生物类似药 (Celltrion)
更新于：2026-09-08
概要
基本信息
药物类型 生物类似药、单克隆抗体 |
别名 Anti-TNF alpha Mab、Anti-TNF alpha monoclonal antibody、Infliximab Biosimilar (Celltrion, Inc.) + [14] |
靶点 |
作用方式 抑制剂 |
作用机制 TNF-α抑制剂(肿瘤坏死因子α抑制剂) |
在研适应症 |
非在研适应症 |
原研机构 |
最高研发阶段批准上市 |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构/序列
Sequence Code 69038H
当前序列信息引自: *****
关联
45
项与 英夫利西单抗生物类似药 (Celltrion) 相关的临床试验JPRN-jRCT2031250197
Single-arm, Open-label, Phase 3, Multi-center Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients with Ulcerative Colitis in Japan (CT-P13 3.13)
CTIS2024-513213-13-00
Direct comparison between NSAIDs and biosimilar TNFa blockers in patients with axial spondyloarthritis
NCT06738719
A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Evaluate the Efficacy and Safety of Subcutaneous CT-P13 in Patients With Moderately to Severely Active Rheumatoid Arthritis
100 项与 英夫利西单抗生物类似药 (Celltrion) 相关的临床结果
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100 项与 英夫利西单抗生物类似药 (Celltrion) 相关的转化医学
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100 项与 英夫利西单抗生物类似药 (Celltrion) 相关的专利（医药）
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419
项与 英夫利西单抗生物类似药 (Celltrion) 相关的文献（医药）2026-07-30Intestinal Research
Effectiveness, safety, and pharmacokinetics of the infliximab biosimilar CT-P13 after non-medical switch from the infliximab originator in patients with inflammatory bowel disease
Article
作者: Arima, Hisatomi ; Takahashi, Atsushi ; Takeda, Teruyuki ; Takatsu, Noritaka ; Imakiire, So ; Hirai, Fumihito ; Yamauchi, Eri ; Yasukawa, Shigeyoshi ; Ono, Yoichiro ; Nomaru, Ryohei ; Kanemitsu, Takao ; Mikumo, Hiroyuki ; Hisabe, Takashi ; Miyaoka, Masaki ; Koga, Akihiro ; Ashizuka, Shinya
Background/Aims: The introduction of anti-tumor necrosis factor-α antibodies transformed the landscape of inflammatory bowel disease (IBD) treatment. Because biologics are associated with increased medical costs, the use of biosimilars (BS) is recommended. However, high-quality evidence on the efficacy of BS in Japan remains limited. Therefore, this study aimed to evaluate the efficacy and safety of BS in patients with IBD.Methods: Patients with IBD who underwent a non-medical switch (NMS) from infliximab originator (IFX-O) to IFX-BS at Fukuoka University Chikushi Hospital were prospectively evaluated. The observation period was up to 56 weeks after the NMS, and the rate of continuation, clinical remission at 56 weeks, safety, and changes in trough concentration were analyzed. Moreover, a questionnaire survey regarding BS and NMS was conducted.Results: A total of 167 patients were included in this study. The continuation rate for IFX-BS therapy after NMS was high (95.6%). The remission maintenance rate at 56 weeks was 85.7% for patients with Crohn’s disease and 77.8% for patients with ulcerative colitis. Adverse events were observed in 22.8% of patients. However, only 2 severe adverse events were recorded. The ratios of trough concentrations at 8, 24, and 56 weeks to that at week 0 were 115.6%, 101.2%, and 123.5%, respectively, indicating statistical non-inferiority. In a questionnaire survey, only 6.2% of the patients were aware of BS, however, more than half of them agreed with the NMS recommendation.Conclusions: The efficacy and safety of IFX-BS after NMS are high. In addition, its trough concentration is serologically non-inferior to baseline values.
2026-07-07Journal of Crohns & Colitis
Correction to: Subcutaneous infliximab (CT-P13 SC) as maintenance therapy for Crohn’s disease and ulcerative colitis: 2-year results from open-label extensions of two randomized controlled trials (LIBERTY)
2026-07-01Therapeutic Advances in Gastroenterology
Immunomodulators and advanced therapies for maintenance of remission in Crohn’s disease: systematic review and network meta-analysis
Article
作者: Gordon, Morris ; Arruda Navarro Albuquerque, Daniel ; Vuyyuru, Sudheer Kumar ; Liu, Shiyao ; Radford, Shellie Jane ; Ajiboye, Aderonke ; Sinopoulou, Vassiliki ; Moran, Gordon William
Background::
With the range of options available for the treatment of Crohn’s disease, therapy selection can be challenging in clinical practice. Comparative efficacy data are needed to clarify the relative position of the increasingly complex portfolio of advanced therapies and guide decision-making.
Objectives::
Our aim was to compare all advanced and immunomodulator treatments for efficacy and safety in maintenance of remission.
Design::
Systematic review and network meta-analysis.
Data sources and methods::
We searched databases up to June 2025. Our outcomes were clinical relapse, loss of response, endoscopic relapse, and safety outcomes. We estimated risk ratio (RR) and 95% confidence interval (CI). We used GRADE to assess certainty of results, and surface under the cumulative ranking curve for ranking treatments.
Results::
A total of 37 randomised controlled trials with 7415 participants were included. Interventions ranged between 22 weeks and 2 years. Adalimumab probably prevents clinical relapse over placebo (RR 0.68, 95% CI 0.54–0.84, Number Needed to Treat (NNT) = 2, moderate effect magnitude). CT-P13 (RR 0.52, 95% CI 0.38–0.71) and infliximab (RR 0.61, 95% CI 0.49–0.76) may prevent clinical relapse. Upadacitinib is more effective than placebo at preventing loss of clinical response (RR 0.64, 95% CI 0.57–0.72, NNT = 2, small magnitude), while CT-P13 (RR 0.46, 95% CI 0.35–0.53, NNT = 1, large magnitude), natalizumab (RR 0.54, 95% CI 0.43–0.68, NNT = 2, moderate magnitude), certolizumab (RR 0.57, 95% CI 0.47–0.7), NNT = 2, moderate magnitude), adalimumab (RR 0.68, 95% CI 0.61–0.75, NNT = 2, small effect magnitude) and ustekinumab (RR 0.73, 95% CI 0.61–0.86, NNT = 2, small magnitude) probably prevent loss of clinical response. Infliximab (RR 0.7, 95% CI 0.59–0.82) and vedolizumab (RR 0.82, 95% CI 0.68–0.99) may prevent loss of clinical response. Endoscopic relapse could not be analysed. Safety evidence is uncertain, but treatments appear generally safe in the short term.
Conclusion::
Adalimumab has moderate certainty for maintaining clinical remission with a moderate effect size. Novel therapies seem to have similar effect sizes, though imprecision due to limited evidence precludes further conclusions.
Trial registration::
https://knowledge.lancashire.ac.uk/id/eprint/53237/
157
项与 英夫利西单抗生物类似药 (Celltrion) 相关的新闻（医药）2026-09-05
生物类似药临床3期临床结果
2026-09-03
100 项与 英夫利西单抗生物类似药 (Celltrion) 相关的药物交易
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研发状态
批准上市
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 |
|---|---|---|---|
| 白塞病/贝赫切特综合征 | 日本 | 2026-02-18 | |
| 白塞病/贝赫切特综合征 | 日本 | 2026-02-18 | |
| 白塞氏葡萄膜炎 | 日本 | 2020-04-01 | |
| 白塞氏葡萄膜炎 | 日本 | 2020-04-01 | |
| 红皮病性银屑病 | 日本 | 2015-07-22 | |
| 红皮病性银屑病 | 日本 | 2015-07-22 | |
| 红皮病性银屑病 | 日本 | 2015-07-22 | |
| 寻常性银屑病 | 日本 | 2015-07-22 | |
| 寻常性银屑病 | 日本 | 2015-07-22 | |
| 寻常性银屑病 | 日本 | 2015-07-22 | |
| 脓疱型银屑病 | 日本 | 2015-07-22 | |
| 脓疱型银屑病 | 日本 | 2015-07-22 | |
| 脓疱型银屑病 | 日本 | 2015-07-22 | |
| 强直性脊柱炎 | 欧盟 | 2013-09-10 | |
| 强直性脊柱炎 | 欧盟 | 2013-09-10 | |
| 强直性脊柱炎 | 冰岛 | 2013-09-10 | |
| 强直性脊柱炎 | 冰岛 | 2013-09-10 | |
| 强直性脊柱炎 | 列支敦士登 | 2013-09-10 | |
| 强直性脊柱炎 | 列支敦士登 | 2013-09-10 | |
| 强直性脊柱炎 | 挪威 | 2013-09-10 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 自身免疫性疾病 | 临床前 | 英国 | 2024-08-20 |
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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
N/A | 24 | 願鏇憲觸繭願製醖選廠(齋醖鏇選蓋夢構鑰選窪) = 鹽顧窪憲繭願齋觸艱鑰 觸製願鹽鹹範淵積淵積 (蓋構繭鑰夢餘鹽鑰製蓋 ) | 积极 | 2026-05-03 | |||
願鏇憲觸繭願製醖選廠(齋醖鏇選蓋夢構鑰選窪) = 鬱蓋簾鹹繭願獵簾築構 觸製願鹽鹹範淵積淵積 (蓋構繭鑰夢餘鹽鑰製蓋 ) | |||||||
N/A | 136 | subcutaneous infliximab (IV → SC switch) | 夢蓋蓋餘憲鏇願鏇衊鏇(膚壓醖鏇夢構顧積顧窪) = The switch from IV infliximab to SC infliximab is well tolerated amongst patients. 簾糧齋觸積鏇鏇糧壓艱 (襯範衊廠蓋構窪窪鹽築 ) 更多 | 积极 | 2025-10-06 | ||
临床3期 | - | 選淵膚簾簾壓餘廠膚膚(淵製艱艱顧壓淵襯選鹽) = 鹹繭鹽積遞廠夢艱繭餘 獵獵願糧顧選繭憲憲願 (糧顧鹹艱淵獵選糧衊築 ) 更多 | 积极 | 2025-06-04 | |||
N/A | - | 觸齋築構製鹽餘壓廠製(獵鑰淵齋醖醖糧製鬱鏇) = In UC, 84.7% (61/72) vs 78.1% (132/169), In CD, 86.8% (33/38) vs 79.7% (118/148) 艱糧蓋鹽窪願夢廠範淵 (餘構壓膚壓願範齋觸鏇 ) 更多 | - | 2024-10-13 | |||
临床1期 | 112 | 積構艱衊鹹憲糧製獵繭(醖築築築淵遞廠繭蓋廠) = Similar 糧製鏇鹹廠範襯製窪鹽 (構鬱簾鏇鑰願夢淵淵鏇 ) 更多 | 积极 | 2024-07-01 | |||
IV-to-SC switch group | |||||||
临床3期 | - | CT-P13 SC 120 mg | 鬱築廠鹽膚鏇壓鬱選鏇(衊糧製網築選鹹蓋廠鬱) = 構積簾鏇範鏇鏇顧壓構 齋遞簾淵範壓鹹選淵衊 (齋觸鏇遞顧網願醖製夢 ) 更多 | 积极 | 2024-05-23 | ||
Placebo | 鬱築廠鹽膚鏇壓鬱選鏇(衊糧製網築選鹹蓋廠鬱) = 繭齋鏇遞蓋鏇構糧簾艱 齋遞簾淵範壓鹹選淵衊 (齋觸鏇遞顧網願醖製夢 ) 更多 | ||||||
临床3期 | 180 | 餘憲鬱範繭壓獵願積構(願壓願壓蓋淵壓憲廠齋) = There was no new safety issue reported during the extension phase. 衊衊鬱鏇繭衊選鏇膚壓 (艱糧簾窪襯選願鏇糧鹹 ) | 积极 | 2024-02-21 | |||
N/A | 20 | Subcutaneous IFX (CT-P13) | 廠網鏇壓餘簾窪憲觸遞(簾廠壓壓鹽蓋夢繭顧鑰) = 廠壓鏇醖餘艱製鹹積鹽 艱觸鑰網餘遞範鏇餘獵 (窪鹽糧襯鑰鏇遞醖繭膚 ) 更多 | 积极 | 2024-02-21 | ||
临床3期 | 237 | 糧廠範衊憲範艱鹹廠膚(遞繭簾顧憲夢襯壓築觸) = 選繭夢窪鹽鏇鹽衊淵糧 遞夢範壓壓範襯構鏇繭 (顧襯築鏇積蓋襯窪糧餘 ) 更多 | 积极 | 2024-02-21 | |||
NEWS 人工标引  | 临床3期 | - | (Crohn's disease) | 觸願選齋膚淵範鹹願鏇(壓選窪壓獵壓積鬱遞窪) = The recommended dose for subcutaneous infliximab is 120 mg once every 2 weeks 鹹鬱衊壓獵構窪鹽壓糧 (築淵獵選鬱膚廠憲獵糧 ) 更多 | 积极 | 2023-10-16 | |
(ulcerative colitis) |
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