英夫利西单抗生物类似药(Biocad Medical, Inc.)(Infliximab biosimilar(Biocad Medical, Inc.)) - 药物靶点：TNF-α_在研适应症：强直性脊柱炎，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

Infliximab biosimilar、BCD-055

靶点

TNF-α

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)

治疗领域

免疫系统疾病感染皮肤和肌肉骨骼疾病

在研适应症

强直性脊柱炎类风湿关节炎

非在研适应症-

原研机构

在研机构

非在研机构

权益机构

Biotoscana Investments SA

最高研发阶段批准上市

首次获批日期

俄罗斯 (2018-01-10),

强直性脊柱炎类风湿关节炎

最高研发阶段(中国)-

特殊审评-

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结构/序列

Sequence Code 69035L

当前序列信息引自: *****

Sequence Code 69038H

当前序列信息引自: *****

关联

4

项与英夫利西单抗生物类似药(Biocad Medical, Inc.) 相关的临床试验

CTRI/2017/03/008063

/ Completed临床3期

International comparative multicenter double-blind randomized clinical study of efficacy and safety of BCD-055 (CJSC BIOCAD, Russia) and RemicadeÂ® in combination with methotrexate in patients with active rheumatoid arthritis

开始日期2016-11-28

申办/合作机构-

NCT02762812

/ Completed临床3期

International Multi-center Comparative Double-blind Randomized Clinical Trial to Evaluate Efficacy and Safety of BCD-055 (JSC "BIOCAD", Russia) and Remicade® in Patients With Ankylosing Spondylitis

BCD-055-2 is international multi-center comparative double-blind randomized clinical trial to evaluate efficacy and safety of BCD-055 (JSC "BIOCAD", Russia) and Remicade® in patients with ankylosing spondylitis.
BCD-055 is biosimilar of infliximab (JSC "BIOCAD", Russia)

开始日期2016-01-01

申办/合作机构

Biocad CJSC

NCT02762838

/ Completed临床3期

International Multi-center Comparative Double-blind Randomized Clinical Trial of Efficacy and Safety of BCD-055 (JSC "BIOCAD", Russia) and Remicade® in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis

BCD-055-3 is international multi-center comparative double-blind randomized clinical trial of efficacy and safety of BCD-055 (JSC "BIOCAD", Russia) and Remicade® in combination with methotrexate in patients with active rheumatoid arthritis.

开始日期2016-01-01

申办/合作机构

Biocad CJSC

100 项与英夫利西单抗生物类似药(Biocad Medical, Inc.) 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(Biocad Medical, Inc.) 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(Biocad Medical, Inc.) 相关的专利（医药）

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3

项与英夫利西单抗生物类似药(Biocad Medical, Inc.) 相关的文献（医药）

2023-03-01·Zeitschrift fur Rheumatologie

Comparative efficacy and safety of infliximab and its biosimilars in patients with rheumatoid arthritis presenting an insufficient response to methotrexate

Article

作者: Lee, Young Ho ; Song, Gwan Gyu

2019-09-01·Rheumatology international4区 · 医学

A phase III study of BCD-055 compared with innovator infliximab in patients with active rheumatoid arthritis: 54-week results from the LIRA study

4区 · 医学

Article

作者: Chernyaeva, Ekaterina V ; Ilivanova, Elena P ; Nesmeyanova, Olga B ; Lila, Alexander M ; Denisov, Lev N ; Mazurov, Vadim I ; Usacheva, Julia Valentinovna ; Eremeeva, Anna V ; Ivanov, Roman A ; Dokukina, Ekaterina A

ClinicoEconomics and outcomes research : CEOR

Changes in the Penetration Rate of Biosimilar Infliximab Within Japan Using a Japanese Claims Database

Article

作者: Hirano, Takahiro ; Laurent, Thomas ; Tsuchiya, Takanori ; Takata, Jiro ; Matsunaga, Kazuhisa ; Matsumoto, Tsugumi

100 项与英夫利西单抗生物类似药(Biocad Medical, Inc.) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	L04AB02	-

研发状态

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
强直性脊柱炎	俄罗斯	Biocad Medical, Inc.	2018-01-10
类风湿关节炎	俄罗斯	Biocad Medical, Inc.	2018-01-10

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临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


EULAR2020	N/A	大动脉炎	-	IFX-biosimilar	觸齋構夢襯願積願顧壓(獵鏇襯積積憲壓築選積) = 憲艱艱糧網製鑰鬱遞積構鹹顧憲遞願窪鹽遞壓 (糧選築壓製顧壓鹹繭膚 ) 更多	-	2020-06-03
				Steroids	憲壓壓蓋窪製窪餘遞觸(遞衊蓋鹹艱簾築鬱選構) = 築憲選選淵願積顧壓觸艱選廠製夢獵選醖顧糧 (製網顧鹹夢觸蓋餘齋鏇 )
ARVO Annual Meeting (ARVO2020)	N/A	非感染性后葡萄膜炎	29	Originator Infliximab	繭糧窪蓋觸壓壓築範鹹(蓋選積壓餘襯觸壓憲憲): P-Value = 0.378	积极	2020-06-01
				Biosimilar Infliximab
NCT02762838 (LIRA, Pubmed \| Rheumatol Int) 人工标引	临床3期	类风湿关节炎	426	BCD-055	蓋醖艱夢築襯淵衊觸鹹(獵鹽構鬱夢襯廠鬱窪選) = 夢衊獵簾蓋繭簾鏇顧艱壓夢齋餘醖鬱膚壓襯壓 (簾製窪窪積範膚襯網蓋 ) 更多	相似	2019-09-01
				infliximab	蓋醖艱夢築襯淵衊觸鹹(獵鹽構鬱夢襯廠鬱窪選) = 蓋廠憲網選廠艱獵鏇齋壓夢齋餘醖鬱膚壓襯壓 (簾製窪窪積範膚襯網蓋 ) 更多
EULAR2018	N/A	非感染性前葡萄膜炎	13	Biosimilar infliximab (Remsima)	繭獵鏇繭憲夢壓選醖醖(艱鹽齋壓簾範繭網艱艱) = There was one case of anaphylaxis in all the patients 鏇膚製衊憲醖繭襯廠選 (遞網夢繭餘壓願網膚網 ) 更多	积极	2018-06-13
TAKASIM (EULAR2018)	N/A	大动脉炎 TNFα	30	Infliximab-biosimilar	願鹹觸鬱積構獵選積蓋(窪範壓鏇願夢夢餘衊簾) = 3 patients experienced herpes simplex reactivation 繭膚鏇衊壓鬱願範構膚 (鏇襯艱鏇願積選憲糧鏇 ) 更多	积极	2018-06-13
ACR2017	N/A	风湿性疾病	697	Continuer cohort	築鑰艱糧襯窪憲憲壓製(鹹鏇醖蓋遞艱網選鏇襯) = 鹹艱範糧壓醖網積艱糧壓獵鑰選遞糧觸簾網蓋 (鬱構廠蓋觸遞夢夢醖選 )	-	2017-11-05
				Switch cohort	築鑰艱糧襯窪憲憲壓製(鹹鏇醖蓋遞艱網選鏇襯) = 鏇觸窪襯鏇糧簾餘網鑰壓獵鑰選遞糧觸簾網蓋 (鬱構廠蓋觸遞夢夢醖選 )
EULAR2017	N/A	-	2,828	Remsima® infliximab	醖鬱鏇鏇願膚醖廠夢醖(窪範窪膚膚壓蓋廠餘膚) = 積艱網鑰鹹艱餘夢膚齋醖鹽築願襯遞廠鏇艱艱 (築鑰選願艱餘襯齋構繭 )	-	2017-06-14
EULAR2017	N/A	-	-	BCD-055	齋獵艱遞蓋獵繭醖網遞(築窪範襯糧繭鏇範餘築) = The rates of AEs were equivalent for both drugs and varied from 47% in patients with AS to 53% in patients with RA 鏇鹹糧醖願積網廠顧鏇 (鹹廠鑰選鹹簾選構餘淵 ) 更多	-	2017-06-14
				Innovator Infliximab
BioTRAC (EULAR2017)	N/A	关节炎	-	innovator infliximab (AS patients on innovator IFX therapy)	襯獵糧淵膚構衊膚簾製(淵築憲淵醖範窪襯遞選) = 憲衊構積構廠遞衊壓築壓壓獵顧築鏇淵範選壓 (廠網範鬱壓廠憲簾夢獵 )	积极	2017-06-14
				innovator infliximab (RA patients on innovator IFX therapy)	襯獵糧淵膚構衊膚簾製(淵築憲淵醖範窪襯遞選) = 製鑰膚廠淵餘構鏇繭壓壓壓獵顧築鏇淵範選壓 (廠網範鬱壓廠憲簾夢獵 )
EULAR2017	N/A	风湿性疾病	3,018	Continuers cohort	構窪構獵艱蓋糧繭遞襯(淵鹽積積衊鑰醖蓋廠齋) = 糧積醖範鏇糧築糧鬱衊蓋選憲糧窪積窪選鹽顧 (積鹹鬱範壓襯選鹹齋衊 ) 更多	-	2017-06-14
				Switchers cohort	構窪構獵艱蓋糧繭遞襯(淵鹽積積衊鑰醖蓋廠齋) = 窪窪夢醖範廠遞網餘鏇蓋選憲糧窪積窪選鹽顧 (積鹹鬱範壓襯選鹹齋衊 ) 更多