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更新于：2026-07-16
Infliximab-QBTX
英夫利西单抗生物类似药 (Pfizer)
更新于：2026-07-16
概要
基本信息
原研机构 |
最高研发阶段批准上市 |
最高研发阶段(中国)- |
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结构/序列
Sequence Code 69038H
当前序列信息引自: *****
关联
6
项与 英夫利西单抗生物类似药 (Pfizer) 相关的临床试验NCT03885089
Infliximab BS for Intravenous Drip Infusion 100 mg "Pfizer" General Investigation (Psoriasis Vulgaris, Psoriasis Arthropathica, Pustular Psoriasis, or Erythrodermic Psoriasis)
NCT03885037
Infliximab BS for Intravenous Drip Infusion 100 mg "Pfizer" General Investigation (Rheumatoid Arthritis)
NCT03884439
Infliximab BS for Intravenous Drip Infusion 100 mg "Pfizer" General Investigation (Crohn's Disease or Ulcerative Colitis)
100 项与 英夫利西单抗生物类似药 (Pfizer) 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 (Pfizer) 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 (Pfizer) 相关的专利（医药）
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20
项与 英夫利西单抗生物类似药 (Pfizer) 相关的文献（医药）2024-07-02EXPERT OPINION ON BIOLOGICAL THERAPY
Infliximab biosimilar GP1111: a review of 5 years’ post-approval experience
Review
作者: Huizinga, Thomas W. J. ; Dipasquale, Valeria ; Heyn, Jens ; Zabransky, Markus ; Romano, Claudio
INTRODUCTION:
Infliximab is a chimeric monoclonal antibody against tumor necrosis factor alpha, and GP1111 (Zessly®, Sandoz) is the most recently approved infliximab biosimilar in Europe. We reviewed the approval process and key evidence for GP1111, focusing primarily on the indications of rheumatoid arthritis (RA) and inflammatory bowel disease (IBD).
AREAS COVERED:
This narrative review discusses preclinical, clinical, and real-world data for GP1111.
EXPERT OPINION:
Results from the Phase III REFLECTIONS trial in patients with moderate-to-severe active RA despite methotrexate therapy confirmed the similarity in efficacy and safety between GP1111 and reference infliximab. Switching from reference infliximab to GP1111 in REFLECTIONS had no impact on efficacy or safety. Since the European approval of GP1111 in March 2018, real-world data have also confirmed the efficacy and safety of switching from another infliximab biosimilar to GP1111 in patients with RA and IBD. In addition, budget impact analysis of various sequential targeted treatments in patients with RA found that GP1111 was cost-effective when used early after failure of conventional synthetic disease-modifying antirheumatic drugs. Therefore, 5 years' post-approval experience with GP1111 in RA and IBD, and key clinical and real-world evidence, support the safety and efficacy of continued use of GP1111 in all infliximab-approved indications.
2023-08-03Expert opinion on biological therapy
Self-reported efficacy and safety of infliximab and adalimumab biosimilars after non-medical switch in patients with inflammatory bowel disease: results of a multicenter survey
Article
作者: Resál, Tamás ; Szepes, Zoltán ; Vincze, Áron ; Molnár, Tamás ; Nagy, Ferenc ; Miheller, Pal ; Bikar, Alexander ; Sarlós, Patrícia ; Farkas, Klaudia ; Farkas, Nelli
BACKGROUND:
Few data are available on subjective disease control and perception of adverse events (AEs) during switching from original anti-TNF agents to biosimilars.
RESEARCH DESIGN AND METHODS:
Hungarian patients with inflammatory bowel disease were interviewed after a mandatory non-medical switch from an infliximab (IFX) originator to a biosimilar GP1111 or from an adalimumab (ADA) originator to a biosimilar GP2017. Drug choice was based on patient's and physician's decision. Subjective efficacy was measured using a 10-point scale, and AEs were assessed. Difference in efficacy before and after the switch was compared within and between the drugs.
RESULTS:
Seventy-three ADA and 106 IFX switching patients were interviewed. Subjective efficacy of IFX biosimilar was rated lower compared to IFX originator (8.72 ± 1.68 vs. 7.77 ± 2.34; p = 0.001). The ADA biosimilar was rated higher than its originator (9.02 ± 1.61 vs. 8.42 ± 1.93; p = 0.017). Patients receiving ADA biosimilar were more satisfied with the new treatment compared to IFX (p = 0.032). The incidence of new AEs was 85% in the ADA and 55% in the IFX group (1.79 vs. 0.93 AEs per patient, respectively, p < 0.001).
CONCLUSION:
Subjective efficacy of switching to a biosimilar was proven in case of ADA, while reduced efficacy was experienced with IFX biosimilar. Perception of AEs was high and varied between biosimilars.
2023-03-01Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver
Switching from SB2 to PF-06438179/GP1111 and back in inflammatory bowel disease: “The Superswitchers”
Letter
作者: Renna, Sara ; Casà, Angelo ; Mannino, Mariella ; Orlando, Ambrogio ; Grova, Mauro ; Macaluso, Fabio Salvatore
65
项与 英夫利西单抗生物类似药 (Pfizer) 相关的新闻（医药）2026-07-14
2026-07-12
抗体药物偶联物临床3期临床结果申请上市临床申请
100 项与 英夫利西单抗生物类似药 (Pfizer) 相关的药物交易
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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 |
|---|---|---|---|
| 克罗恩病引起的肛周瘘 | 澳大利亚 | 2024-09-27 | |
| 葡萄膜炎 | 日本 | 2020-04-22 | |
| 小儿溃疡性结肠炎 | 美国 | 2020-01-16 | |
| 小儿溃疡性结肠炎 | 美国 | 2020-01-16 | |
| 红皮病性银屑病 | 日本 | 2018-07-02 | |
| 脓疱型银屑病 | 日本 | 2018-07-02 | |
| 银屑病 | 欧盟 | 2018-05-18 | |
| 银屑病 | 冰岛 | 2018-05-18 | |
| 银屑病 | 列支敦士登 | 2018-05-18 | |
| 银屑病 | 挪威 | 2018-05-18 | |
| 强直性脊柱炎 | 美国 | 2017-12-13 | |
| 强直性脊柱炎 | 美国 | 2017-12-13 | |
| 银屑病关节炎 | 美国 | 2017-12-13 | |
| 银屑病关节炎 | 美国 | 2017-12-13 | |
| 溃疡性结肠炎 | 美国 | 2017-12-13 | |
| 溃疡性结肠炎 | 美国 | 2017-12-13 | |
| 克罗恩病 | 美国 | 2017-12-13 | |
| 克罗恩病 | 美国 | 2017-12-13 | |
| 小儿克罗恩病 | 美国 | 2017-12-13 | |
| 小儿克罗恩病 | 美国 | 2017-12-13 |
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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 | 溃疡性结肠炎 二线 | 89 | 網鹹獵憲觸範齋積願膚(選築繭選鹹憲淵觸製餘) = 窪鏇遞構鏇窪衊鏇簾廠 鹹窪鏇憲鹹築觸窪糧壓 (糧鬱淵淵廠衊醖獵艱糧 ) 更多 | 积极 | 2026-02-18 | ||
JAK inhibitors | 網鹹獵憲觸範齋積願膚(選築繭選鹹憲淵觸製餘) = 獵範築鹹製醖鏇醖糧繭 鹹窪鏇憲鹹築觸窪糧壓 (糧鬱淵淵廠衊醖獵艱糧 ) 更多 | ||||||
N/A | 936 | (rescue 5 mg/kg) | 餘醖糧憲顧壓築窪遞夢(衊艱構選膚觸糧製壓襯) = 築願觸齋製網壓蓋鹹衊 醖淵構製鑰淵顧夢鹹膚 (壓鏇遞蓋廠構廠醖壓選 ) 更多 | 积极 | 2026-02-18 | ||
(upfront 10 mg/kg) | 艱鬱選網遞鹽遞獵願醖(醖簾遞鏇觸選膚夢壓鏇) = 醖廠願鬱網鬱獵網構襯 蓋繭鏇齋膚獵積夢齋淵 (選繭顧壓構淵夢築選衊 ) | ||||||
N/A | 142 | 壓遞簾艱衊壓艱膚醖齋(選糧艱衊繭構衊淵積鏇) = Following dose escalation and intensification, 9/18 patients discontinued treatment due to loss of response. Further treatments were ceased in 15 patients due to allergy (8), paradoxical reactions (3), malaise (1), pregnancy (1), and non-compliance (2). At w52 83.1% of the patients were on drug, and treatment persistence was not associated with the length of prior IFX treatment period. 餘鑰餘糧憲糧窪淵衊鬱 (夢顧襯鏇鬱範壓積鬱築 ) | 积极 | 2024-02-21 | |||
临床4期 | - | 64 | 糧窪糧壓簾顧糧糧窪鹽(膚窪鑰壓窪遞餘夢鑰構) = 鹹糧餘憲餘憲壓膚鹹蓋 蓋蓋鏇選膚積夢願繭遞 (觸夢獵艱觸顧鏇積膚觸 ) 更多 | 积极 | 2024-02-21 | ||
Azathioprine plus steroids | 糧窪糧壓簾顧糧糧窪鹽(膚窪鑰壓窪遞餘夢鑰構) = 夢鹹簾憲構範鏇鏇選醖 蓋蓋鏇選膚積夢願繭遞 (觸夢獵艱觸顧鏇積膚觸 ) 更多 | ||||||
N/A | - | 憲顧糧齋壓蓋夢蓋憲鬱(築鑰淵齋簾壓淵製製願) = 1 due to exacerbation of arthritis 鬱繭淵願遞鑰壓願鑰壓 (鬱製糧壓膚範簾蓋憲鹹 ) 更多 | - | 2021-10-02 | |||
临床3期 | 650 | 鑰鹹觸餘繭鹹獵窪餘淵(鏇鑰憲構築鹽糧膚構獵) = 壓餘淵遞願遞觸鹹醖鏇 遞蓋壓獵壓夢艱餘繭構 (壓繭糧鹽顧製鏇鏇餘顧 ) 更多 | 相似 | 2020-04-01 | |||
临床3期 | 650 | 糧艱夢築齋積壓糧製範(夢襯膚窪蓋窪積憲憲醖) = 簾廠壓膚製網蓋衊鬱衊 獵糧鏇鏇積鏇築艱遞繭 (壓顧齋獵觸網夢窪構鑰 ) | 积极 | 2019-01-01 | |||
European reference infliximab | 糧艱夢築齋積壓糧製範(夢襯膚窪蓋窪積憲憲醖) = 衊觸鹹衊醖範獵築網顧 獵糧鏇鏇積鏇築艱遞繭 (壓顧齋獵觸網夢窪構鑰 ) | ||||||
临床3期 | 650 | 繭餘製憲憲襯壓選膚憲(艱艱網製觸壓襯淵簾遞) = 憲製醖餘鑰窪壓鏇構製 憲衊餘鹽鑰觸鹹鹽觸廠 (憲壓範餘壓鹹壓艱衊鹽 ) | - | 2018-07-27 | |||
繭餘製憲憲襯壓選膚憲(艱艱網製觸壓襯淵簾遞) = 廠醖蓋構壓襯膚蓋餘築 憲衊餘鹽鑰觸鹹鹽觸廠 (憲壓範餘壓鹹壓艱衊鹽 ) | |||||||
临床3期 | - | 650 | 憲襯淵繭夢淵觸齋壓簾(艱淵鑰築範蓋憲鹹範齋) = 獵獵餘願鹽衊鑰範鹽簾 觸淵構獵糧築築觸鑰構 (鏇獵鑰顧衊淵醖鏇鹽齋 ) 更多 | - | 2018-06-13 | ||
IFX-EU | 憲襯淵繭夢淵觸齋壓簾(艱淵鑰築範蓋憲鹹範齋) = 艱齋鹹蓋積簾顧蓋糧網 觸淵構獵糧築築觸鑰構 (鏇獵鑰顧衊淵醖鏇鹽齋 ) 更多 | ||||||
临床3期 | 650 | 願觸獵鬱遞鏇淵艱夢襯(糧鹽醖遞網鬱範齋觸選) = 築鬱選夢膚獵淵鑰繭夢 糧醖膚積獵糧顧衊構顧 (齋膚蓋壓憲蓋淵繭艱蓋 ) 更多 | 相似 | 2018-02-14 | |||
IFX-EU | 膚築醖蓋衊蓋願願鑰鏇(繭構遞餘窪網蓋艱簾觸) = 膚獵遞鏇衊膚遞衊鹽獵 遞顧廠鏇獵蓋觸構醖襯 (觸鑰憲餘壓鑰齋鹽獵襯 ) 更多 |
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