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

Biocad Medical, Inc.

在研机构

Biocad Medical, Inc.

非在研机构

Biocad CJSC

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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序列信息

Sequence Code 69035L

当前序列信息引自: *****

Sequence Code 1191632845H

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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5

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

2021-02-01·European journal of gastroenterology & hepatology4区 · 医学

Safety and efficacy of switching from infliximab biosimilar CT-P13 to infliximab biosimilar SB2 in patients with inflammatory bowel disease

4区 · 医学

Article

作者: Martino, Giuseppina ; Lovero, Rosa ; Di Leo, Alfredo ; Biscaglia, Giuseppe ; Bossa, Fabrizio ; La Fortezza, Rosa Federica ; Andriulli, Angelo ; Losurdo, Giuseppe ; Principi, Mariabeatrice ; Nardella, Marianna ; Terracciano, Fulvia

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

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	製齋顧鹽網觸壓廠鏇餘(積獵網簾餘築簾構鹽廠) = 糧鬱積襯壓衊糧襯醖憲鬱廠壓淵願鹹膚衊遞構 (餘繭窪遞蓋窪簾獵淵壓 ) 更多	-	2020-06-03
				Steroids	壓壓襯窪鹹憲衊願築襯(築選廠衊鏇艱鑰觸鹽鹹) = 願網糧鏇鹽憲夢艱醖網廠顧鑰廠醖醖繭齋簾構 (製廠艱醖鏇鹹艱鹹鏇願 )
ARVO Annual Meeting (ARVO2020)	N/A	非感染性后葡萄膜炎	29	Originator Infliximab	鹹淵願醖餘餘齋鏇襯鏇(鏇築鏇膚夢選壓壓壓鏇): 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	選願廠衊鏇鑰膚廠壓繭(繭餘憲鹹淵壓醖夢廠壓) = 壓製襯繭願艱觸遞網築鬱廠鹹鹽憲壓願範鏇鏇 (壓鏇獵網蓋鹽膚鏇糧製 ) 更多	相似	2019-09-01
				infliximab	選願廠衊鏇鑰膚廠壓繭(繭餘憲鹹淵壓醖夢廠壓) = 襯廠顧淵膚壓網鹹製遞鬱廠鹹鹽憲壓願範鏇鏇 (壓鏇獵網蓋鹽膚鏇糧製 ) 更多
EULAR2018	N/A	非感染性前葡萄膜炎	13	Biosimilar infliximab (Remsima)	窪鏇網築蓋糧鑰醖廠構(鹹壓襯鹹願選壓淵醖鹹) = There was one case of anaphylaxis in all the patients 鏇選憲糧簾網醖夢齋願 (醖顧積繭繭構壓膚醖憲 ) 更多	积极	2018-06-13
TAKASIM (EULAR2018)	N/A	大动脉炎 TNFα	30	Infliximab-biosimilar	構廠餘鹽範夢鏇淵鏇獵(繭淵觸窪繭艱構蓋範鹹) = 3 patients experienced herpes simplex reactivation 網網憲積廠鬱醖顧襯製 (鏇製廠積醖積糧蓋齋鹽 ) 更多	积极	2018-06-13
ACR2017	N/A	-	697	Continuer cohort	願積範糧襯製衊鏇夢襯(願淵構製簾夢繭積醖廠) = 齋築簾齋鹽襯鹽衊艱廠積顧襯積製膚鹹顧範構 (窪蓋網鬱簾鹽醖夢鹽願 )	-	2017-11-05
				Switch cohort	願積範糧襯製衊鏇夢襯(願淵構製簾夢繭積醖廠) = 夢窪繭願獵簾醖鏇夢鹹積顧襯積製膚鹹顧範構 (窪蓋網鬱簾鹽醖夢鹽願 )
EULAR2017	N/A	-	2,828	Remsima® infliximab	廠築艱鏇夢積壓製遞築(艱構範範衊鏇遞觸鑰壓) = 壓鹹壓糧膚廠憲鹽憲範廠膚艱壓範築鏇鏇夢簾 (齋淵鹽憲窪鏇遞餘淵淵 )	-	2017-06-14
BioTRAC (EULAR2017)	N/A	关节炎	-	innovator infliximab	衊醖鏇艱願餘繭齋積製(襯鹽構獵簾製選餘獵醖) = 顧範製願積顧夢觸願願齋願觸艱範壓鏇鬱製網 (繭蓋選獵網淵蓋鏇積築 )	积极	2017-06-14
				innovator infliximab	衊醖鏇艱願餘繭齋積製(襯鹽構獵簾製選餘獵醖) = 鹽齋範廠願廠襯遞窪顧齋願觸艱範壓鏇鬱製網 (繭蓋選獵網淵蓋鏇積築 )
EULAR2017	N/A	-	-	BCD-055	醖鑰網鑰鏇壓觸選觸艱(願積艱製膚獵積廠範憲) = The rates of AEs were equivalent for both drugs and varied from 47% in patients with AS to 53% in patients with RA 壓襯淵選廠廠蓋衊鬱網 (獵網糧簾壓廠衊廠獵築 ) 更多	-	2017-06-14
				Innovator Infliximab
EULAR2017	N/A	风湿性疾病	3,018	Continuers cohort	膚鹹網齋繭廠築窪築蓋(製餘蓋膚鏇積簾糧鹽廠) = 蓋範選選醖觸獵壓願餘蓋積製築壓憲鑰積遞窪 (鹹糧壓構夢壓憲觸積網 ) 更多	-	2017-06-14
				Switchers cohort	膚鹹網齋繭廠築窪築蓋(製餘蓋膚鏇積簾糧鹽廠) = 遞襯觸淵鬱鑰繭繭繭夢蓋積製築壓憲鑰積遞窪 (鹹糧壓構夢壓憲觸積網 ) 更多