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

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 1191632845H

当前序列信息引自: *****

Sequence Code 69035L

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-

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

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

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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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 für Rheumatologie

A network meta-analysis

Article

作者: Song, Gwan Gyu ; Lee, Young Ho

OBJECTIVETo assess the relative efficacy and safety of infliximab and its biosimilars in patients with active rheumatoid arthritis (RA) who showed an inadequate response to methotrexate (MTX).METHODSWe performed a Bayesian network meta-analysis combining direct and indirect evidence from randomized controlled trials (RCTs), comparing the efficacy and safety of infliximab biosimilars versus the originator product in patients with active RA despite receiving MTX.RESULTSOverall, 7 RCTs involving 3168 patients, including 7 biologic agents, met the inclusion criteria. The NI-071 was listed at the top left of the diagonal of the league table because it was associated with the most favorable surface under the cumulative ranking curve (SUCRA) for the American College of Rheumatology 20 (ACR20) response rate. SB2 was listed at the bottom right of the diagonal of the league table because it was associated with the least favorable results. Based on SUCRA, NI-071 had the highest probability of being the best treatment agent in terms of the ACR20 response rate (SUCRA = 0.731), followed by ABP 710, CT-P13, BCD-055, infliximab, Exemptia, PF-06438179, and SB2 (SUCRA = 0.311). Although statistically non-significant differences in safety ranking were observed for serious adverse events (SAEs) among the treatment options, ABP 710 presented the highest safety probability (SUCRA = 0.739) while BCD-055 showed the lowest safety profile (SUCRA = 0.289).CONCLUSIONNo significant difference in ACR20 response rates and SAEs were detected between infliximab biosimilars and the originator in the investigated study populations.

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

IntroductionFor patients with inflammatory bowel diseases, switching from infliximab originator to biosimilars is effective and safe. Few data on single switch have been published, and data on multiple switches of different infliximab are unavailable.MethodsA retrospective analysis of patients who switched from CT-P13 to SB2, and of those with multiple switches among different infliximab compounds was conducted. Clinical activity, C reactive protein (CRP), adverse events (AE) and loss of response (LOR) were recorded.ResultsThirty-six patients (26 males, 14 Crohn’s disease and 22 ulcerative colitis) were enrolled and followed up for >6 months. All patients switched from CT-P13 to SB2; 12 of them (33.3%) had already switched from reference Infliximab to CT-P13, and for the remaining patients CT-P13 was the first infliximab. The clinical remission rate six months before and three months after SB2-switch was the same (58.3%) and the rate of mild activity varied from 27.8 to 33.3% (P = 0.68); the percentage of patients with normal CRP values passed from 94.4 to 91.7% (P = 1). Two patients (5.5%) had AE and 11 (30.5%) a LOR. At univariate analysis, patients with a single switch had a non-significant risk of LOR during SB2 [odds ratio (OR) = 7.86; 95% confidence interval (CI) 0.87–71, P = 0.06]. SB2-LOR was associated with previous AE under CT-P13 (OR = 9.1, 95% CI 0.82–100, P = 0.07). None of such factors was significant at multivariate analysis.ConclusionSwitching from CT-P13 to SB2 seems to be safe and effective either in patients with a single than in those with multiple switches.

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

BCD-055 is a biosimilar of innovator infliximab (IFX). Here we present the 54-week results from phase 3 clinical study in patients with rheumatoid arthritis (RA). The aim of this study was to demonstrate the equivalent efficacy and safety of BCD-055 and IFX in patients with active rheumatoid arthritis. 426 adults with active RA were enrolled. Patients were randomized into 2 study arms in 2:1 ratio to receive BCD-055 or IFX innovator in dose of 3 mg/kg at week 0, 2, 6 and then every 8 weeks up to week 54. Primary efficacy endpoint was the rate of American College of Rheumatology (ACR) 20 response at week 14. The equivalence margin was set as 15%. Immunogenicity and safety were also assessed. Rate of ACR20 at week 14 in PP (Per-Protocol) population was 71.2% in BCD-055 group and 67.9% in IFX group. Difference in ACR20 rates between groups was 3.2% with 95% CI [- 7.0%; 13.5%] (р = 0.587). Throughout 54-week study period, both groups were characterized by similar rates of ACR20/50/70 response at all timepoints without significant differences (p > 0.05). The rates of adverse events (AE) were similar in groups (74.64% in BCD-055 arm vs 66.67% in IFX arm, p = 0.111). Antibodies to infliximab were detected in 28.46% patients for BCD-055 arm and 26.56% for IFX arm (p = 0.786). BCD-055 and IFX were comparable in efficacy (including radiographic progression), safety and immunogenicity throughout the 54-week study.Trial registration ClinicalTrials.gov ID, number NCT02762838.

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

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
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

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
强直性脊柱炎	临床1期	俄罗斯	Biocad CJSC	2016-01-01
类风湿关节炎	临床1期	白俄罗斯	Biocad CJSC	2016-01-01
类风湿关节炎	临床1期	俄罗斯	Biocad CJSC	2016-01-01
类风湿关节炎	临床1期	印度	Biocad CJSC	2016-01-01

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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


ARVO Annual Meeting (ARVO2020)	N/A	非感染性后葡萄膜炎	29	Originator Infliximab	(觸齋膚鹽鹽壓糧鹹簾夢): 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	(積壓艱製網網艱願蓋鏇) = 構願鹽餘鏇構壓衊築遞範壓壓遞製顧獵艱鏇淵 (鏇顧獵齋憲製顧窪選鹹 ) 更多	相似	2019-09-01
				infliximab	(積壓艱製網網艱願蓋鏇) = 夢鹹鬱範鹽範壓鑰襯蓋範壓壓遞製顧獵艱鏇淵 (鏇顧獵齋憲製顧窪選鹹 ) 更多
EULAR2019	N/A	炎症 anti-drug antibodies (ADA)	265	Innovator infliximab	(顧衊鏇繭築積蓋網餘獵) = 選壓遞觸顧願鏇夢範鏇獵範廠鹹鑰鬱鬱淵窪積 (夢糧鹽壓願糧淵壓鑰構 ) 更多	-	2019-06-12
				First biosimilar infliximab	(顧衊鏇繭築積蓋網餘獵) = 簾構衊艱淵淵鏇鹹齋觸獵範廠鹹鑰鬱鬱淵窪積 (夢糧鹽壓願糧淵壓鑰構 )
EULAR2019	N/A	-	-	Infliximab biosimilar	(範廠獵壓襯範膚廠願衊) = 遞鏇糧蓋願醖壓獵憲顧範繭鬱齋衊襯網觸鹹構 (齋築醖願醖衊餘觸顧夢 ) 更多	-	2019-06-12
				Etanercept biosimilar	(範廠獵壓襯範膚廠願衊) = 願蓋鏇餘艱窪膚鹹窪鏇範繭鬱齋衊襯網觸鹹構 (齋築醖願醖衊餘觸顧夢 ) 更多
TAKASIM (EULAR2018)	N/A	大动脉炎 TNFα	30	Infliximab-biosimilar	(衊築選簾選築範艱蓋顧) = 3 patients experienced herpes simplex reactivation 簾鑰壓製夢餘衊獵廠積 (夢醖製淵餘範鑰積窪範 ) 更多	积极	2018-06-13
BioTRAC (EULAR2017)	N/A	关节炎	-	innovator infliximab	(鬱網網鑰蓋遞獵範製獵) = 艱蓋糧糧獵鹹鬱築鬱築鬱蓋膚壓齋醖鑰淵蓋衊 (願鹽遞鹽顧鑰壓衊顧選 )	积极	2017-06-14
				innovator infliximab	(鬱網網鑰蓋遞獵範製獵) = 鹹膚鑰積艱顧選簾襯鏇鬱蓋膚壓齋醖鑰淵蓋衊 (願鹽遞鹽顧鑰壓衊顧選 )
EULAR2017	N/A	-	-	BCD-055	(衊積憲憲鹽齋糧餘襯憲) = The rates of AEs were equivalent for both drugs and varied from 47% in patients with AS to 53% in patients with RA 齋窪憲鏇鹽簾鏇網遞範 (糧鹽構糧顧觸構網齋鏇 ) 更多	-	2017-06-14
				Innovator Infliximab
EULAR2016	N/A	风湿性疾病 sIFX \| ADA	96	Originator infliximab	醖遞艱衊憲衊顧簾鬱範(衊齋積衊鬱簾願簾遞餘) = 鬱製遞餘鑰繭餘簾蓋積獵餘顧觸鏇築淵觸淵觸 (襯鹹憲夢夢積憲蓋艱艱 )	积极	2016-06-08
				Biosimilar infliximab	醖遞艱衊憲衊顧簾鬱範(衊齋積衊鬱簾願簾遞餘) = 襯構鑰製鹹窪構夢築願獵餘顧觸鏇築淵觸淵觸 (襯鹹憲夢夢積憲蓋艱艱 )
NCT02359903 (CTgov)	临床1期	强直性脊柱炎	90	Infliximab (BCD-055) (BCD-055 Group)	鬱艱窪艱積憲艱願繭鏇(餘鹹齋願繭範網顧鑰遞) = 繭窪觸選網齋齋願繭廠衊衊壓積遞製鏇顧遞鑰 (觸膚選製網鬱衊製襯淵, 廠餘衊襯製糧襯繭窪製 ~ 鬱鏇襯壓憲醖鬱齋鏇鬱) 更多	-	2016-06-08
				Infliximab (Remicade) (Remicade Group)	鬱艱窪艱積憲艱願繭鏇(餘鹹齋願繭範網顧鑰遞) = 夢顧夢廠選窪艱衊壓構衊衊壓積遞製鏇顧遞鑰 (觸膚選製網鬱衊製襯淵, 醖醖蓋鑰網鹹鏇鹽壓構 ~ 鏇膚製夢壓選構淵範顧) 更多
ECCO2016	N/A	炎症性肠病维持	72	Originator infliximab	艱遞繭衊構餘鑰遞糧鹹(願衊範膚餘鏇製齋襯鹹) = 構襯遞淵衊壓簾築淵醖顧醖繭餘築鏇鹹窪網觸 (壓齋廠糧獵製襯蓋鏇鑰 )	积极	2016-02-12
				Biosimilar infliximab	艱遞繭衊構餘鑰遞糧鹹(願衊範膚餘鏇製齋襯鹹) = 膚壓淵鬱衊艱夢願觸衊顧醖繭餘築鏇鹹窪網觸 (壓齋廠糧獵製襯蓋鏇鑰 )