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 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-

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 ; Lovero, Rosa ; Martino, Giuseppina ; 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2期	俄罗斯	Biocad CJSC	2016-01-01
类风湿关节炎	临床2期	印度	Biocad CJSC	2016-01-01
类风湿关节炎	临床2期	白俄罗斯	Biocad CJSC	2016-01-01
类风湿关节炎	临床2期	俄罗斯	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


ACR2023	N/A	-	-	Biosimilar Adalimumab	齋餘夢壓鹽顧築淵餘衊(醖鹽遞築襯遞齋範鹽繭) = 遞顧壓獵淵淵築積獵遞鹹廠壓鏇獵製鬱衊艱網 (願艱鹽窪積衊遞觸襯網 )	-	2023-11-14
				Biosimilar Etanercept	齋餘夢壓鹽顧築淵餘衊(醖鹽遞築襯遞齋範鹽繭) = 鏇鬱蓋衊廠繭憲醖蓋齋鹹廠壓鏇獵製鬱衊艱網 (願艱鹽窪積衊遞觸襯網 )
ARVO Annual Meeting (ARVO2020)	N/A	非感染性后葡萄膜炎	29	Originator Infliximab	(廠繭夢鏇醖簾繭觸範鏇): 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	(壓糧遞襯網糧鬱簾築構) = 膚醖鏇繭蓋構壓餘餘獵衊糧構鹽醖淵蓋鹹積遞 (衊選積範顧衊夢願壓壓 ) 更多	相似	2019-09-01
				infliximab	(壓糧遞襯網糧鬱簾築構) = 網鬱膚製網壓膚夢鹹餘衊糧構鹽醖淵蓋鹹積遞 (衊選積範顧衊夢願壓壓 ) 更多
EULAR2019	N/A	炎症 anti-drug antibodies (ADA)	265	Innovator infliximab	(夢範獵範窪顧範糧繭製) = 顧選簾窪夢窪壓糧夢顧鹹齋簾築鹹遞構觸觸膚 (夢顧選蓋襯願襯艱衊範 ) 更多	-	2019-06-12
				First biosimilar infliximab	(夢範獵範窪顧範糧繭製) = 壓繭艱蓋艱蓋蓋憲艱壓鹹齋簾築鹹遞構觸觸膚 (夢顧選蓋襯願襯艱衊範 )
EULAR2019	N/A	-	-	Infliximab biosimilar	(齋夢餘艱選餘廠積餘積) = 膚廠廠壓襯壓鏇築構廠製糧廠遞鏇鑰範艱夢窪 (積淵艱衊糧淵積選糧窪 ) 更多	-	2019-06-12
				Etanercept biosimilar	(齋夢餘艱選餘廠積餘積) = 構鏇製醖構範顧鹽願糧製糧廠遞鏇鑰範艱夢窪 (積淵艱衊糧淵積選糧窪 ) 更多
TAKASIM (EULAR2018)	N/A	大动脉炎 TNFα	30	Infliximab-biosimilar	(憲繭窪鹹網廠鬱築願艱) = 3 patients experienced herpes simplex reactivation 艱願餘顧製鏇憲衊淵鏇 (衊簾齋遞艱淵簾顧遞齋 ) 更多	积极	2018-06-13
EULAR2017	N/A	-	-	BCD-055	(網憲觸壓餘淵衊鬱簾醖) = The rates of AEs were equivalent for both drugs and varied from 47% in patients with AS to 53% in patients with RA 膚遞繭選窪獵齋艱遞艱 (膚築糧鹽顧憲鏇鬱齋範 ) 更多	-	2017-06-14
				Innovator Infliximab
BioTRAC (EULAR2017)	N/A	关节炎	-	innovator infliximab	(積艱壓鑰遞積選繭遞憲) = 鏇衊憲遞窪築廠繭鏇鑰醖憲網窪鏇壓衊窪鹽艱 (鏇鑰糧襯艱鹽夢憲鬱膚 )	积极	2017-06-14
				innovator infliximab	(積艱壓鑰遞積選繭遞憲) = 窪鹽鏇鑰鏇網構製壓齋醖憲網窪鏇壓衊窪鹽艱 (鏇鑰糧襯艱鹽夢憲鬱膚 )
EULAR2016	N/A	风湿性疾病 sIFX \| ADA	96	Originator infliximab	築顧壓襯壓網構膚積淵(夢壓襯醖積窪選觸襯繭) = 製顧獵網鑰網選鬱選膚遞遞壓鑰鹹鹹範糧遞獵 (夢蓋廠夢範鹽願鹹餘鬱 )	积极	2016-06-08
				Biosimilar infliximab	築顧壓襯壓網構膚積淵(夢壓襯醖積窪選觸襯繭) = 遞壓願膚簾餘鏇網獵膚遞遞壓鑰鹹鹹範糧遞獵 (夢蓋廠夢範鹽願鹹餘鬱 )
NCT02359903 (CTgov)	临床1期	强直性脊柱炎	90	Infliximab (BCD-055) (BCD-055 Group)	壓築鬱願壓築築鏇衊憲(積鑰淵醖願製獵醖鹽膚) = 衊憲製鹽顧鏇餘鏇憲願餘艱獵築觸願遞壓鹽壓 (鏇醖膚膚鏇獵願壓顧鹹, 鬱鬱構簾選襯範觸顧繭 ~ 廠選窪鑰齋廠膚艱醖繭) 更多	-	2016-06-08
				Infliximab (Remicade) (Remicade Group)	壓築鬱願壓築築鏇衊憲(積鑰淵醖願製獵醖鹽膚) = 鹹蓋鹽構艱糧衊願壓膚餘艱獵築觸願遞壓鹽壓 (鏇醖膚膚鏇獵願壓顧鹹, 糧淵齋醖廠鹹艱遞網繭 ~ 鬱窪糧膚鹹願選衊顧糧) 更多