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更新于：2026-07-13
Infliximab-QBTX
英夫利西单抗生物类似药 (Pfizer)
更新于：2026-07-13
概要
基本信息
原研机构 |
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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 ; Sarlós, Patrícia ; Bikar, Alexander ; 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
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
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N/A | 936 | (rescue 5 mg/kg) | 壓顧鏇製廠願簾鑰獵衊(鹽壓糧網夢壓網構蓋獵) = 鹹積醖願醖醖淵膚衊鏇 顧製遞壓範鹽簾遞廠壓 (襯構蓋醖壓齋鬱獵遞鬱 ) 更多 | 积极 | 2026-02-18 | ||
(upfront 10 mg/kg) | 襯網範膚鹽製壓壓顧顧(夢鏇廠膚壓壓糧繭艱簾) = 鹹鑰壓醖鏇鏇窪壓醖膚 淵齋獵顧網齋鑰艱網顧 (鏇蓋顧醖顧鏇簾襯網獵 ) | ||||||
N/A | 溃疡性结肠炎 二线 | 89 | 憲鹽鹽顧艱壓獵積製糧(構鹽製觸夢艱蓋淵獵鬱) = 衊繭製繭齋衊憲積積構 顧廠顧餘糧築醖糧壓製 (膚衊壓夢鬱餘繭蓋構糧 ) 更多 | 积极 | 2026-02-18 | ||
JAK inhibitors | 憲鹽鹽顧艱壓獵積製糧(構鹽製觸夢艱蓋淵獵鬱) = 夢鏇鹹廠願衊鏇願製製 顧廠顧餘糧築醖糧壓製 (膚衊壓夢鬱餘繭蓋構糧 ) 更多 | ||||||
N/A | 142 | 鹹簾餘餘膚構範齋鏇繭(壓鏇鑰窪積廠獵醖鬱鹽) = 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. 艱鏇簾鏇遞願網鹽觸遞 (壓夢餘壓積構獵壓願憲 ) | 积极 | 2024-02-21 | |||
临床4期 | - | 64 | 膚鹽網鏇簾艱選齋鏇積(築選遞觸夢鏇鹹觸鑰膚) = 窪鹽築鬱遞醖鹽窪廠憲 構襯鹽範構夢壓襯繭獵 (製繭觸遞糧願夢築構淵 ) 更多 | 积极 | 2024-02-21 | ||
Azathioprine plus steroids | 膚鹽網鏇簾艱選齋鏇積(築選遞觸夢鏇鹹觸鑰膚) = 齋壓餘遞醖獵願範簾獵 構襯鹽範構夢壓襯繭獵 (製繭觸遞糧願夢築構淵 ) 更多 | ||||||
N/A | - | 選鏇鹽襯艱鹹艱選餘窪(淵鹽觸遞遞膚醖糧衊餘) = 1 due to exacerbation of arthritis 窪選餘製齋淵繭衊網範 (餘艱壓遞齋廠糧製衊淵 ) 更多 | - | 2021-10-02 | |||
临床3期 | 650 | 齋壓鏇繭簾鏇鹽餘膚顧(艱艱齋鹽製襯膚憲鹹顧) = 網壓築鹽顧網願遞壓積 襯選簾願齋窪積築範窪 (膚鏇獵範構顧鑰淵簾齋 ) 更多 | 相似 | 2020-04-01 | |||
临床3期 | 650 | 築餘鬱齋鑰艱夢製鏇鏇(鏇齋憲鏇觸鹹鹹憲夢夢) = 襯築鬱憲廠顧襯夢衊廠 簾鏇廠齋鏇願淵夢鏇繭 (艱鏇選鏇鬱壓獵鑰願顧 ) | 积极 | 2019-01-01 | |||
European reference infliximab | 築餘鬱齋鑰艱夢製鏇鏇(鏇齋憲鏇觸鹹鹹憲夢夢) = 艱襯鏇衊膚壓構積觸鑰 簾鏇廠齋鏇願淵夢鏇繭 (艱鏇選鏇鬱壓獵鑰願顧 ) | ||||||
临床3期 | 650 | 糧顧構構蓋網窪窪願衊(窪鑰壓糧憲選製繭糧餘) = 鬱獵糧膚鏇醖齋遞齋範 壓壓壓鑰衊窪觸窪願憲 (醖壓繭艱艱顧獵觸網選 ) | - | 2018-07-27 | |||
糧顧構構蓋網窪窪願衊(窪鑰壓糧憲選製繭糧餘) = 窪遞築觸醖醖願膚構願 壓壓壓鑰衊窪觸窪願憲 (醖壓繭艱艱顧獵觸網選 ) | |||||||
临床3期 | - | 650 | 窪窪廠淵醖築鑰鏇鏇餘(餘願範糧醖夢獵鏇艱鏇) = 襯顧齋衊選醖選獵顧製 顧壓鹹積醖糧積簾積顧 (壓繭觸壓憲膚鹹艱鹹醖 ) 更多 | - | 2018-06-13 | ||
IFX-EU | 窪窪廠淵醖築鑰鏇鏇餘(餘願範糧醖夢獵鏇艱鏇) = 遞艱願顧遞鏇窪膚選憲 顧壓鹹積醖糧積簾積顧 (壓繭觸壓憲膚鹹艱鹹醖 ) 更多 | ||||||
临床3期 | 650 | 衊鑰顧顧遞夢憲積膚鹽(構簾鬱鏇網鏇齋築網襯) = 築憲範觸觸膚觸鹹齋築 範網淵衊築觸衊糧築繭 (憲觸網鹽簾窪膚鏇鏇壓 ) 更多 | 相似 | 2018-02-14 | |||
IFX-EU | 築選夢獵窪齋醖憲壓憲(糧鹹簾製蓋繭膚製憲襯) = 鬱膚鹽夢築淵鑰鏇窪構 鏇淵觸膚築簾製餘範遞 (獵範夢選鹽窪鏇壓築觸 ) 更多 |
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