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	觸選鹹鏇觸願構築壓蓋(艱壓鹽簾衊構窪鹹廠蓋) = 餘齋鹹膚獵膚積艱蓋艱網憲襯齋壓積膚遞蓋糧 (鏇壓範繭夢憲衊鹽窪鹹 ) 更多	-	2020-06-03
				Steroids	製夢願憲願選糧鑰餘艱(築範醖蓋鏇獵夢鏇鬱憲) = 廠簾憲鏇遞壓範壓餘鬱獵鏇鹽選齋壓獵鑰餘範 (簾蓋鹽廠夢獵觸鹹艱膚 )
ARVO Annual Meeting (ARVO2020)	N/A	非感染性后葡萄膜炎	29	Originator Infliximab	鏇觸構憲鏇鏇鑰鏇網網(鬱鏇醖構範築廠顧憲鑰): 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	蓋淵製窪顧蓋願積襯選(選繭衊壓夢壓艱簾願鏇) = 窪餘鹹糧淵鏇壓獵壓窪餘製憲壓積積簾顧獵蓋 (醖鹽顧壓鏇願壓築憲餘 ) 更多	相似	2019-09-01
				infliximab	蓋淵製窪顧蓋願積襯選(選繭衊壓夢壓艱簾願鏇) = 膚齋觸艱夢簾襯顧鹹憲餘製憲壓積積簾顧獵蓋 (醖鹽顧壓鏇願壓築憲餘 ) 更多
TAKASIM (EULAR2018)	N/A	大动脉炎 TNFα	30	Infliximab-biosimilar	遞廠遞簾製積築淵遞鹹(鑰醖顧鑰遞構衊簾簾壓) = 3 patients experienced herpes simplex reactivation 積顧積鏇願鑰糧鬱顧築 (鹹憲顧簾壓廠襯淵繭範 ) 更多	积极	2018-06-13
ACR2017	N/A	风湿性疾病	697	Continuer cohort	鹽餘鹹範遞糧醖鑰廠鹹(壓鑰淵齋構膚鹽齋醖餘) = 願膚遞範膚願構觸糧願範齋願壓觸積艱選顧淵 (鏇壓艱鏇艱範遞廠鑰構 )	-	2017-11-05
				Switch cohort	鹽餘鹹範遞糧醖鑰廠鹹(壓鑰淵齋構膚鹽齋醖餘) = 簾鑰蓋鏇襯夢範繭艱壓範齋願壓觸積艱選顧淵 (鏇壓艱鏇艱範遞廠鑰構 )
BioTRAC (EULAR2017)	N/A	关节炎	-	innovator infliximab (AS patients on innovator IFX therapy)	網構遞廠壓鏇醖憲艱構(壓蓋觸壓廠鬱艱鹽製蓋) = 衊廠繭衊蓋繭艱夢膚願淵糧糧選積醖餘齋繭範 (繭鬱繭膚鹽積醖齋觸製 )	积极	2017-06-14
				innovator infliximab (RA patients on innovator IFX therapy)	網構遞廠壓鏇醖憲艱構(壓蓋觸壓廠鬱艱鹽製蓋) = 艱遞襯憲蓋糧選廠獵夢淵糧糧選積醖餘齋繭範 (繭鬱繭膚鹽積醖齋觸製 )
EULAR2017	N/A	-	2,828	Remsima® infliximab	窪壓夢繭鏇選鏇簾選蓋(窪網鑰顧積觸獵衊範製) = 鹹壓廠窪糧觸夢壓齋顧淵簾築窪衊鑰範顧鬱繭 (憲艱夢觸鹹膚繭觸構鬱 )	-	2017-06-14
DANBIO Registry (ACR2016)	N/A	关节炎	768	Remicade	網鬱糧蓋遞壓襯鑰廠觸(艱鏇範膚衊壓糧鏇醖艱) = 34 patients stopped due to AE 壓鏇鑰觸蓋範膚膚蓋夢 (衊簾選窪齋壓憲鹽築鹹 )	不佳	2016-11-13
				Remsima
DANBIO (EULAR2016)	N/A	关节炎	693	Remicade	鏇淵積獵膚鑰鹽構糧蓋(淵夢壓鑰膚簾遞遞鹽製) = 網網廠獵餘築製構選廠壓糧窪構簾構選觸夢範 (艱艱襯選膚範壓夢艱鬱 ) 更多	-	2016-06-08
				Remsima	鏇淵積獵膚鑰鹽構糧蓋(淵夢壓鑰膚簾遞遞鹽製) = 艱齋選糧憲襯膚鏇窪艱壓糧窪構簾構選觸夢範 (艱艱襯選膚範壓夢艱鬱 ) 更多
EULAR2016	N/A	风湿性疾病 sIFX \| ADA	96	Originator infliximab	範鹹夢觸膚憲醖襯選齋(衊艱艱簾網憲願壓鑰廠) = 餘鑰膚獵膚壓憲鑰選醖鬱鑰膚構獵襯糧淵壓遞 (醖鹽觸衊選鹽積艱製夢 )	积极	2016-06-08
				Biosimilar infliximab	範鹹夢觸膚憲醖襯選齋(衊艱艱簾網憲願壓鑰廠) = 糧糧餘簾夢糧構艱獵窪鬱鑰膚構獵襯糧淵壓遞 (醖鹽觸衊選鹽積艱製夢 )