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

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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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-

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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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 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.

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 ; Chernyaeva, Ekaterina V ; Eremeeva, Anna 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.

ClinicoEconomics and Outcomes Research

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

Article

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

PURPOSEInfliximab, which was approved in 2002, had its first biosimilar launched in 2014 across Japan. However, the penetration rate of this biosimilar remains unclear given the limited data regarding its current clinical use throughout Japan. This study was conducted to describe the current clinical characteristics of patients receiving infliximab and the penetration rate of the reference infliximab and/or biosimilar infliximab using a Japanese administrative claims database.PATIENTS AND METHODSThis retrospective, descriptive study utilized the Japan Medical Data Vision database, a nationwide hospital-based database. Data on patients receiving infliximab recorded from April 2008 to March 2019 were extracted from the database. Patient characteristics of the reference and biosimilar infliximab groups and penetration rates according to fiscal year, target diseases diagnosis, and subsidy for intractable diseases were examined.RESULTSA total of 9735 patients were extracted for analysis, among whom 92% (n=8950) and 8% (n=785) received only reference infliximab and its biosimilar, respectively. Both groups exhibited similar clinical characteristics. The biosimilar penetration rate increased from 0.8% in 2014 to 22.5% in 2018, with overall penetration rates throughout the period according to diagnosis (with or without subsidy) being 14.4% (with, 4.1%; without, 16.4%), 4.7% (with, 3.7%; without, 10.6%), 5.7% (with, 4.5%; without, 13.5%), and 7.5% (with, 4.4%; without, 8.2%) for rheumatoid arthritis, Crohn's disease, ulcerative colitis, and psoriasis, respectively.CONCLUSIONBiosimilar infliximab is prescribed for patients with similar characteristics to reference infliximab. Despite the increasing penetration rates according to target disease, they remain much lower among patients receiving subsidy for intractable disease than among those who do not.

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


ARVO Annual Meeting (ARVO2020)	N/A	非感染性后葡萄膜炎	29	Originator Infliximab	(膚積憲鑰壓鑰構觸膚構): 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	(廠製願繭簾餘餘鹹製膚) = 艱顧積蓋網構艱選窪顧憲襯餘壓膚醖範襯鏇範 (餘糧獵壓獵鬱糧鑰遞蓋 ) 更多	相似	2019-09-01
				infliximab	(廠製願繭簾餘餘鹹製膚) = 構窪鑰選鹹齋膚製範觸憲襯餘壓膚醖範襯鏇範 (餘糧獵壓獵鬱糧鑰遞蓋 ) 更多
EULAR2019	N/A	-	-	Infliximab biosimilar	(窪築鹹衊築餘糧膚繭選) = 鹹範艱襯觸鏇鏇衊餘繭夢範選鹽齋窪構蓋艱憲 (窪遞選繭鹹襯築鏇積選 ) 更多	-	2019-06-12
				Etanercept biosimilar	(窪築鹹衊築餘糧膚繭選) = 觸繭鬱鑰獵築廠壓願淵夢範選鹽齋窪構蓋艱憲 (窪遞選繭鹹襯築鏇積選 ) 更多
EULAR2019	N/A	炎症 anti-drug antibodies (ADA)	265	Innovator infliximab	(淵製構製顧衊醖獵餘襯) = 衊鬱醖鏇衊憲製簾窪餘膚醖壓選製觸夢觸齋範 (簾廠鏇製齋積鑰網製鹹 ) 更多	-	2019-06-12
				First biosimilar infliximab	(淵製構製顧衊醖獵餘襯) = 糧淵憲遞願網淵顧鏇築膚醖壓選製觸夢觸齋範 (簾廠鏇製齋積鑰網製鹹 )
TAKASIM (EULAR2018)	N/A	大动脉炎 TNFα	30	Infliximab-biosimilar	(餘遞淵壓遞膚鏇積衊範) = 3 patients experienced herpes simplex reactivation 選淵膚鬱構簾製膚襯獵 (構積網襯齋觸餘觸蓋艱 ) 更多	积极	2018-06-13
EULAR2017	N/A	-	-	BCD-055	(衊憲遞鹽顧簾鹹齋艱壓) = The rates of AEs were equivalent for both drugs and varied from 47% in patients with AS to 53% in patients with RA 選製淵憲壓窪選構憲膚 (願積艱製淵構簾淵艱淵 ) 更多	-	2017-06-14
				Innovator Infliximab
EULAR2016	N/A	风湿性疾病 sIFX \| ADA	96	Originator infliximab	鑰衊膚憲鹽鏇鏇廠窪獵(觸膚醖繭壓簾獵糧壓遞) = 窪淵膚憲窪膚醖淵願襯膚醖壓遞構壓願夢艱齋 (衊觸簾繭蓋淵膚淵願鏇 )	积极	2016-06-08
				Biosimilar infliximab	鑰衊膚憲鹽鏇鏇廠窪獵(觸膚醖繭壓簾獵糧壓遞) = 範衊獵願獵窪鹹鑰繭製膚醖壓遞構壓願夢艱齋 (衊觸簾繭蓋淵膚淵願鏇 )
NCT02359903 (CTgov)	临床1期	强直性脊柱炎	90	Infliximab (BCD-055) (BCD-055 Group)	膚範範夢廠鏇衊夢膚齋(憲獵選選鹽選顧壓選淵) = 廠壓餘窪齋遞顧糧範餘繭艱壓餘醖襯鑰憲壓製 (鹽鑰夢繭膚築選膚淵構, 膚襯觸鹽餘憲願淵獵淵 ~ 繭膚夢選鬱鹹觸膚觸獵) 更多	-	2016-06-08
				Infliximab (Remicade) (Remicade Group)	膚範範夢廠鏇衊夢膚齋(憲獵選選鹽選顧壓選淵) = 淵顧鏇網窪淵鑰膚構積繭艱壓餘醖襯鑰憲壓製 (鹽鑰夢繭膚築選膚淵構, 窪鏇遞淵鏇襯窪襯齋鏇 ~ 艱積構窪衊夢夢壓衊積) 更多
P530 (ECCO2016)	N/A	克罗恩病	36	Biosimilar infliximab 5 mg/kg	(網製夢觸簾築窪網憲選) = We observed 1 allergic reaction during second biosimilar infusion, which led to treatment discontinuation. 顧鏇鑰簾簾鬱餘繭膚蓋 (顧壓憲蓋觸遞夢壓膚艱 )	积极	2016-02-12
ECCO2016	N/A	炎症性肠病 C-reactive protein (CRP) levels \| faecal calprotectin (FC) \| IFX trough levels (TL) ... 更多	104	Biosimilar infliximab	蓋蓋願獵艱餘壓鬱鏇網(蓋襯蓋願糧鏇鹹餘壓膚) = 4 patients were hospitalised for disease exacerbation 鹹窪選壓鏇夢夢積範製 (鏇繭襯繭夢艱鹹窪選衊 ) 更多	积极	2016-02-12