英夫利西单抗生物类似药 (EPIRUS Biopharma)(Infliximab biosimilar (EPIRUS Biopharma)) - 药物靶点：TNF-α_在研适应症：类风湿关节炎_专利_临床

概要

基本信息

药物类型

生物类似药、单克隆抗体

别名

Infimab、Infliximab biosimilar

+ [1]

靶点

TNF-α

作用机制

TNF-α抑制剂(肿瘤坏死因子α抑制剂)

治疗领域

免疫系统疾病皮肤和肌肉骨骼疾病

在研适应症

类风湿关节炎

非在研适应症-

原研机构

EPIRUS Biopharmaceuticals, Inc.

在研机构-

非在研机构

Epirus Biopharmaceuticals (Switzerland) GmbH

最高研发阶段批准上市

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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序列信息

Sequence Code 69035L

当前序列信息引自: *****

Sequence Code 69038H

当前序列信息引自: *****

关联

3

项与英夫利西单抗生物类似药 (EPIRUS Biopharma) 相关的临床试验

CTRI/2018/03/012298 / Completed临床4期

A prospective, multi-centre, open label, phase IV studyto evaluate safety and efficacy profile of InfimabTM inpatients with moderate to severe Crohn’s disease

开始日期2018-03-12

申办/合作机构

Reliance Life Sciences Pvt Ltd.

NCT02683564 / Unknown status临床3期

A Study of BOW015 (Infliximab-EPIRUS) and Infliximab in Patients With Active Rheumatoid Arthritis on Stable Methotrexate: The UNIFORM Study

This is a prospective, randomized, double-blind, parallel group, multicentre global phase 3 clinical study to evaluate the efficacy, safety and immunogenicity of BOW015 (infliximab-EPIRUS) compared to Remicade in subjects with active Rheumatoid Arthritis (RA) despite Methotrexate (MTX) therapy.

开始日期2016-02-01

申办/合作机构

Epirus Biopharmaceuticals (Switzerland) GmbH

CTRI/2012/05/002660 / Completed临床3期

A Phase 3, Randomized, Double-Blind, Active Comparator Study of the Efficacy and Safety of R-TPR-015 (1422015) in Patients With Active Rheumatoid Arthritis on stable dose of Methotrexate. - NA

开始日期2012-09-01

申办/合作机构

Reliance Life Sciences Pvt Ltd.

100 项与英夫利西单抗生物类似药 (EPIRUS Biopharma) 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 (EPIRUS Biopharma) 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 (EPIRUS Biopharma) 相关的专利（医药）

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项与英夫利西单抗生物类似药 (EPIRUS Biopharma) 相关的文献（医药）

2022-04-01·Journal of Ocular Pharmacology and Therapeutics4区 · 医学

Current Knowledge of Biologics in Treatment of Noninfectious Uveitis

4区 · 医学

Review

作者: Gupta, Simple ; Vichare, Nitin ; Shyamsundar, K. ; Agrawal, Mohini ; Biswas, Jyotirmay

The arena of uveitis deals with a number of entities, which can be infectious or immune mediated. Noninfectious uveitis (NIU) has been managed with corticosteroids and immunosuppressives. However, their prolonged use has side effects limiting clinical utility in the long run. Improved knowledge regarding pathogenesis of uveitis and associated systemic disease has led to a new epoch in the development of treatment strategies, of which biologics are the recent ones. Biologics revolutionized the management of NIU especially uveitis associated with spondyloarthropathy and refractory uveitis. They target inflammation at a molecular level with less side effects. The most widely used are tumor necrosis factor-alpha inhibitors (infliximab and adalimumab). Other drugs include anti-CD20 inhibitors (rituximab), interleukin-6R-inhibitor (tocilizumab), Interleukin-1R-inhibitor (anakinra), Iinterleukin-2-inhibitor (daclizumab), and the list is further increasing. New advances in biologics are the biosimilar molecules, which are biological products that are highly similar to the reference product, and they include Infimab (biosimilar of infliximab), Exemptia or Adfrar (biosimilar of adalimumab), and Intacept or Etacept (biosimilar of etanercept). Other group of biologics are Janus Associated Kinase inhibitors (JAK-inhibitors), which are long-term oral treatment options of rheumatoid arthritis. They inhibit JAKs, which cause activation of signal transducer and activator of transcription (STAT) proteins, and initiate transcription of inflammatory genes. Many inflammatory cytokines that are implicated in pathogenesis of ocular inflammation are known to utilize the JAK/STAT-signaling pathway, including interleukin-2 (IL-2) and IL-6. Thus, biologics are the future of uveitis treatment with promising results. This article aims to summarize the current knowledge on biologics and their clinical utility in the management of NIU.

2018-02-15·Current Pharmaceutical Design4区 · 医学

The Experience with Biosimilars of Infliximab in Rheumatic Diseases

4区 · 医学

Review

作者: Kos, Igor Age ; Azevedo, Valderilio Feijo ; Ariello, Leonardo

BACKGROUNDInfliximab biosimilars are the first biosimilars of monoclonal antibodies approved by the main regulatory agencies. Up to the present day, two infliximab biosimilars have been approved: CT-P13 (Celltrion), and SB2 (Biogen), but other companies have been developing candidate infliximab biosimilars that are on clinical trials: PF 06438179 (Pfizer), the ABP710 (bioCentury/Amgen) the BCD055 (JSC Biocad Russica) and BOW015 (Epirus).METHODSWe have made a literature search in MedLine database using the key words [Infliximab] and [biosimilars] and [rheumatic diseases] and [rheumatisms]. We have also made a search in the clinicaltrials.org website.CONCLUSIONSClinical data published so far have provided important evidence on long-term efficacy and safety, immunogenicity and switching, supporting the use of CT-P13 and SB2 for the treatment of rheumatic diseases. In addition, the European experience has proved the economic advantages of the incorporation of infliximab biosimilars in clinical practice. Despite the widespread use of infliximab biosimilars there is still a lack of data regarding interchangeability between reference products and biosimilars.

2016-04-01·Int. Journal of Clinical Pharmacology and Therapeutics4区 · 医学

Bioavailability, safety and immunogenicity of biosimilar infliximab (BOW015) compared to reference infliximab

4区 · 医学

Article

作者: Kay, Jonathan ; Knight, Alastair ; Thomson, Elizabeth ; Willers, Joerg ; Wyand, Michael ; Lambert, John ; Shneyer, Lucy ; Lassen, Cheryl

OBJECTIVESTo compare the single-dose pharmacokinetics (PK), safety, and immunogenicity of the biosimilar infliximab (BOW015) to reference infliximab (rIFX) in healthy volunteers and to establish bioequivalence.METHODSIn this randomized, double-blind, parallel-group, single-dose study, subjects received either BOW015 or rIFX. Both drugs were administered as a single IV 5 mg/kg dose over 2 hours on day 1. PK sampling occurred 10 times over 3 days and during safety and immunogenicity follow-up on day 4 and 1, 2, 3, 5, 7, 9, and 12 weeks after the infusion.RESULTSOf the 84 healthy male Caucasian subjects randomized, 43 received BOW015 and 41 received rIFX. PK parameters (geometric mean) for BOW015 vs. rIFX were as follows; C(max) 142.47 vs. 126.74 μg/mL, AUC(0-t) 36,211 vs. 34,304 h×μg/mL, and AUC(0-inf) 36,775 vs. 34,801 h×μg/mL. The point estimates of the BOW015/rIFX geometric mean ratios (90% CI) were; C(max) 1.13 (1.07 - 1.18), AUC(0-t) 1.06 (0.98 - 1.14), and AUC(0-inf) 1.06 (0.98 - 1.15). Overall, anti-drug antibodies were detected in 18.6% of BOW015-treated subjects and 24.4% of rIFX-treated subjects. A total of 26 (60.5%) subjects in the BOW015 group reported 50 treatment-emergent adverse events (TEAEs) and 27 (65.9%) subjects in the rIFX group reported 54 TEAEs.CONCLUSIONSBioequivalence of BOW015 to rIFX is demonstrated as 90% CIs for the study drug mean ratios of C(max), AUC(0-t), and AUC(0-inf) were within the log-transformed ± 20% equivalence range of 0.80 - 1.25. Safety and immunogenicity were also comparable.

1

项与英夫利西单抗生物类似药 (EPIRUS Biopharma) 相关的新闻（医药）

2021-04-14

·GlobeNewswire

New York, April 14, 2021 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Global Biosimilar Monoclonal Antibodies Forecast 2020-2030" - • Along with revenue prediction for the overall world market for biosimilar monoclonal antibodies, our investigation shows forecasts to 2027 for the market segmented by compound: • Infliximab • Rituximab • Abciximab • Trastuzumab • Adalimumab • Bevacizumab • This report also shows revenue to 2027 for individual biosimilar mAb products in the market: • Remsima/Inflectra • Infimab • Reditux • BI695500 • CT-P10 • BI695501 • FKB327 • FKB238 • Mabtas • AcellBia • Maball • Clotinab • Abcixirel • BCD-022 • BCD-021 • Herzuma • CANMAB/Hertraz • Our analyses show individual revenue forecasts to 2027 for these regional and national markets: • The US Biosimilar mAb Market • Japanese Biosimilar mAb Market • EU5 Biosimilar mAb Markets • BRIC and South Korea Biosimilar mAb Markets • Rest of the World Biosimilar mAb Market • This report profiles 10 leading companies either with biosimilar mAbs already on the market or in the pipeline • Our study discusses strengths, weaknesses, opportunities and threats affecting the biosimilar monoclonal antibodies market Read the full report: About Reportlinker ReportLinker is an award-winning market research solution. Reportlinker finds and organizes the latest industry data so you get all the market research you need - instantly, in one place. __________________________

生物类似药抗体

100 项与英夫利西单抗生物类似药 (EPIRUS Biopharma) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	L04AB02	-

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
类风湿关节炎	印度	-	-

未上市

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适应症	最高研发状态	国家/地区	公司	日期
类风湿关节炎	药物发现	-	Epirus Biopharmaceuticals (Switzerland) GmbH	2016-02-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


EULAR2017	临床3期	强直性脊柱炎	68	BOW015	(襯醖鏇餘選廠餘鹹願製) = 積醖膚淵壓夢蓋鏇網憲積憲鏇鹹膚艱範壓艱築 (夢構鑰範繭夢鹹艱艱鏇 ) 更多	积极	2017-06-14
EULAR2015	临床1期	-	-	BOW015	(鑰窪簾襯觸獵製艱衊範) = 鬱膚築襯積齋襯構蓋壓膚願繭襯壓醖鏇積鏇鬱 (壓膚構遞積鏇鬱淵廠鏇 )	-	2015-06-10
				Reference infliximab (rIFX)	(鑰窪簾襯觸獵製艱衊範) = 鹽廠築範簾簾鏇鹹積製膚願繭襯壓醖鏇積鏇鬱 (壓膚構遞積鏇鬱淵廠鏇 )
not available (EULAR2014)	临床3期	类风湿关节炎 CRP ≥10 mg/L \| TB by PPD \| QuantiFERON-TB Gold ... 更多	189	BOW015	(鏇憲鏇繭膚衊窪獵窪齋) = 繭範醖鑰淵顧網窪鑰膚簾鹽淵網蓋窪顧繭壓積 (鏇齋積壓鑰鬱鹽壓糧衊 ) 更多	积极	2014-06-11
				Innovator IFX (iIFX)	(鏇憲鏇繭膚衊窪獵窪齋) = 製顧蓋鹽廠齋襯餘遞鏇簾鹽淵網蓋窪顧繭壓積 (鏇齋積壓鑰鬱鹽壓糧衊 ) 更多