阿达木单抗生物类似药(Biocad Medical, Inc.)(Adalimumab biosimilar(Biocad Medical, Inc.)) - 药物靶点：TNF-α_在研适应症：银屑病，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

Adalimumab 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

在研适应症

非在研适应症

原研机构

在研机构

上海医药集团股份有限公司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 (2019-03-01),

银屑病

最高研发阶段(中国)临床前

特殊审评-

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结构/序列

Sequence Code 26792L

当前序列信息引自: *****

Sequence Code 88699H

当前序列信息引自: *****

关联

2

项与阿达木单抗生物类似药(Biocad Medical, Inc.) 相关的临床试验

NCT02762955

/ Completed临床3期

International Multi-center Comparative Randomized Double-blind Clinical Trial of Efficacy and Safety of BCD-057 (Adalimumab Produced by BIOCAD, Russia) and Humira® (Adalimumab Produced by Vetter Pharma-Fertigung Gmbh & Co KG, Germany) in Patients With Moderate to Severe Plaque Psoriasis

CALYPSO clinical study is a phase 3 study which is carried out to establish the efficacy, safety and pharmacokinetic equivalence of BCD-055 (adalimumab, manufactured by JSC BIOCAD, Russia) and Humira® when used in patients with moderate to severe plaque psoriasis.

开始日期2016-12-01

申办/合作机构

Biocad CJSC

NCT02395055

/ Completed临床1期

Single Center Comparative Double Blind Randomized Clinical Study of Pharmacokinetics, Tolerance and Safety of Single Subcutaneous Injection of BCD-057 (JSC "BIOCAD", Russia) and Humira in Healthy Volunteers

This clinical study is a phase 1 study which carried out to establish the pharmacokinetic equivalence and equal safety and tolerability profile of BCD-057 (adalimumab biosimilar candidate manufactured by CJSC BIOCAD, Russia) and Humira when used as a single subcutaneous injection in healthy volunteers.

开始日期2015-06-01

申办/合作机构

Biocad CJSC

100 项与阿达木单抗生物类似药(Biocad Medical, Inc.) 相关的临床结果

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100 项与阿达木单抗生物类似药(Biocad Medical, Inc.) 相关的转化医学

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100 项与阿达木单抗生物类似药(Biocad Medical, Inc.) 相关的专利（医药）

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5

项与阿达木单抗生物类似药(Biocad Medical, Inc.) 相关的文献（医药）

2022-12-01·Inflammatory Bowel Diseases2区 · 医学

The Sincerest Form of Flattery? Biosimilars in Inflammatory Bowel Disease

2区 · 医学

Article

作者: Farraye, Francis A ; Limdi, Jimmy K ; Cross, Raymond K ; Bhat, Shubha ; Patil, Seema A

Lay SummaryBiosimilar medications have the potential to significantly reduce the cost of treatment in patients with inflammatory bowel disease. Observational studies have shown similar efficacy and safety of biosimilars to biologic reference products. Shared decision-making is crucial to the successful implementation of these agents.

2019-11-01·Biologicals4区 · 生物学

Efficacy and safety of original and biosimilar etanercept (SB4) in active rheumatoid arthritis – A comparison in a real-world national cohort

4区 · 生物学

Article

作者: Ionescu, Ruxandra ; Mogoșan, Corina ; Daia, Sânziana ; Enache, Luminița ; Opriș-Belinski, Daniela ; Popescu, Claudiu C ; Codreanu, Cătălin

OBJECTIVEThe study aims to compare the efficacy and safety of biosimilar etanercept (SB4) to original etanercept (ETN) in a real-life national cohort of rheumatoid arthritis (RA).METHODSData from RA patients were retrieved electronically from the Romanian Registry of Rheumatic Diseases (RRBR), which contains all patients receiving biologics in the country.RESULTSThe study included 242 patients with efficacy and safety data after 6 months of treatment: 123 (50.8%) with ETN, 119 (49.2%) with SB4. There were no significant differences after 6 months regarding composite scores of RA activity between patients on ETN and SB4 (e.g. DAS28 remission: 18.7% in ETN group and 17.6% in SB4 group, p = 0.823; Boolean remission: 11.4% in ETN group and 11.8% in SB4 group, p = 0.926). There were 11 adverse events (AE) in the ETN subgroup (including 3 severe AE: lower respiratory tract infection, enterocolitis and anaphylaxis) and 12 AE in SB4 subgroup (including 4 severe AE: lower respiratory tract infection, vasculitis, anaphylaxis and rash).CONCLUSIONBiosimilar and original etanercept showed similar efficacy and safety after the first 6 months of treatment in RA patients from a national registry, which brings further evidence for biosimilarity in unselected patients in real-world setting.

2019-04-01·Int. Journal of Clinical Pharmacology and Therapeutics

Comparative efficacy and safety of biosimilar rituximab and originator rituximab in combination with methotrexate in patients with active rheumatoid arthritis: A Bayesian network meta-analysis

Article

作者: Young Ho Lee ; Sang Cheol Bae

OBJECTIVEWe aimed to assess the relative efficacy and safety of biosimilar rituximab and originator rituximab plus methotrexate (MTX) compared to those of placebo plus MTX in patients with active rheumatoid arthritis (RA).MATERIALS AND METHODSWe performed a Bayesian network meta-analysis to combine direct and indirect evidence from randomized controlled trials (RCTs) that examined the efficacy and safety of biosimilar+MTX and rituximab+MTX versus placebo+MTX (MTX group) in patients with active RA despite treatment with MTX and/or tumor necrosis factor (TNF) blockers.RESULTSSix RCTs involving 1,747 patients met inclusion criteria. The American College of Rheumatology 20% (ACR20) response rate was significantly higher in the biosimilar+MTX (odds ratio (OR) 4.30, 95% credible interval (CrI) 1.75 - 10.91) and rituximab+MTX (OR 4.07, 95% CrI 2.51 - 7.18) groups than in the MTX group, with no difference in the ACR20 response rate between the biosimilar+MTX and rituximab+MTX groups. The biosimilar+MTX group had the highest probability of being the best treatment based on the ACR20 response rate (surface under the cumulative ranking curve (SUCRA) = 0.7832), followed by rituximab+MTX (SUCRA = 0.7134) and MTX groups (SUCRA = 0.0034). ACR50 and ACR70 response rates showed a distribution pattern similar to ACR20 response rate. Safety based on number of adverse events did not differ significantly among the three interventions after 24 weeks.CONCLUSIONBiosimilar and originator rituximab, combined with MTX, represent an effective intervention for active RA despite treatment with MTX or TNF blockers. No significant difference was found between biosimilar and originator rituximab regarding efficacy and safety.

100 项与阿达木单抗生物类似药(Biocad Medical, Inc.) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	L04AB04	-

研发状态

批准上市

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适应症	国家/地区	公司	日期
银屑病	俄罗斯	Biocad Medical, Inc.	2019-03-01

未上市

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适应症	最高研发状态	国家/地区	公司	日期
类风湿关节炎	临床前	中国	上海医药集团股份有限公司	2022-07-20
斑块状银屑病	临床前	俄罗斯	Biocad CJSC	2016-12-01

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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


EULAR2023	N/A	银屑病关节炎一线	54	Etanercept originator	(鹹壓觸遞鹽積範襯構顧) = 積衊壓鹽蓋遞鬱鏇築選醖艱鑰範襯窪蓋膚夢窪 (餘膚糧簾醖獵構餘觸網 ) 更多	-	2023-05-31
				Adalimumab originator	(鹹壓觸遞鹽積範襯構顧) = 範選糧衊夢選選糧顧鹹醖艱鑰範襯窪蓋膚夢窪 (餘膚糧簾醖獵構餘觸網 ) 更多
EULAR2022	N/A	中轴性脊柱关节炎一线	153	Original Adalimumab	(衊製積選鹹願遞艱壓夢) = 夢壓鬱構廠觸壓獵網廠淵廠選觸窪齋鏇構衊鹽 (廠艱遞糧廠選艱夢餘艱 )	-	2022-06-01
				Biosimilar Adalimumab	(衊製積選鹹願遞艱壓夢) = 鬱範壓顧壓鏇範構醖積淵廠選觸窪齋鏇構衊鹽 (廠艱遞糧廠選艱夢餘艱 )
EULAR2017	N/A	关节炎 TNF-α	200	Biosimilar Adalimumab 40 mg	淵鑰獵窪淵築鹽鬱餘憲(衊衊顧鹽構糧範醖艱膚) = one patient had developed pulmonary tuberculosis in the 4th month of treatment, biosimilar adalimumab was discontinued and AKT treatment was started 夢鹽鹹鹽鑰窪鬱製廠網 (憲艱艱憲鹽鑰憲網窪衊 ) 更多	积极	2017-06-14
NCT02395055 (CTgov)	临床1期	-	94	Adalimumab (BCD-057) (BCD-057 Group)	鹹淵醖積構鹹構繭衊築(製夢淵衊醖蓋艱獵願夢) = 鏇簾膚鬱選淵窪繭積夢蓋鑰選網願築網廠膚醖 (鏇襯鬱觸鹹窪壓製淵齋, 鑰憲淵壓膚襯淵鹹齋構 ~ 獵艱鑰觸網膚鑰願積廠) 更多	-	2016-05-23
				Adalimumab (Humira) (Humira Group)	鹹淵醖積構鹹構繭衊築(製夢淵衊醖蓋艱獵願夢) = 衊築構鬱醖願簾積夢選蓋鑰選網願築網廠膚醖 (鏇襯鬱觸鹹窪壓製淵齋, 積蓋簾膚範鏇觸齋餘鏇 ~ 簾鏇鹽鑰淵壓夢鬱壓淵) 更多