依那西普生物类似药(Mochida Pharmaceutical Co., Ltd.)(Etanercept biosimilar(Mochida Pharmaceutical Co., Ltd.)) - 药物靶点：LTα x TNF-α_在研适应症：幼年型关节炎，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、融合蛋白

别名

Etanercept biosimilar、TNFcept

+ [2]

靶点

LTα x TNF-α

作用机制

LTα抑制剂(肿瘤坏死因子β抑制剂)、TNF-α抑制剂(肿瘤坏死因子α抑制剂)

治疗领域

免疫系统疾病皮肤和肌肉骨骼疾病

在研适应症

幼年型关节炎类风湿关节炎

非在研适应症-

原研机构

Mochida Pharmaceutical Co., Ltd.

在研机构

Mochida Pharmaceutical Co., Ltd.

非在研机构

LG Life Sciences Ltd.

最高研发阶段批准上市

首次获批日期

日本 (2018-01-19),

幼年型关节炎类风湿关节炎

最高研发阶段(中国)-

特殊审评-

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序列信息

Sequence Code 38320

当前序列信息引自: *****

关联

5

项与依那西普生物类似药(Mochida Pharmaceutical Co., Ltd.) 相关的临床试验

NCT02715908 / Completed临床3期

A Extension Clinical Study to Evaluate the Long-term Safety and Efficacy of LBEC0101 When Co-administered With Methotrexate (MTX) for Additional 48 Weeks in Patients With RA Who Have Completed the Treatment Period of LG-ECCL002

To evaluate the long-term safety including immunogenicity and efficacy of LBEC0101 50 mg subcutaneous weekly injection when co-administered with MTX

开始日期2016-04-01

申办/合作机构

LG Life Sciences Ltd.

KCT0002163 / Active, not recruiting临床3期

Multi-center (in Korea and Japan), double-blind, randomized, parallel-group study to evaluate similarity of efficacy and safety of LBEC0101 50mg subcutaneous weekly injection to Enbrel® 50mg subcutaneous weekly injection, as adjunctive therapy to Methotrexate (MTX), in patients with active rheumatoid arthritis who had an inadequate response to MTX

开始日期2015-04-02

申办/合作机构

LG Life Sciences Ltd.

NCT02357069 / Unknown status临床3期

Multi-center (in Korea and Japan), Double-blind, Randomized, Parallel-group Study to Evaluate Similarity of Efficacy and Safety of LBEC0101 50mg Subcutaneous Weekly Injection to Enbrel® 50mg Subcutaneous Weekly Injection, as Adjunctive Therapy to Methotrexate (MTX), in Patients With Active Rheumatoid Arthritis Who Had an Inadequate Response to MTX

This is a randomized, double-blind, parallel group, multicenter clinical study to evaluate the efficacy, safety, pharmacokinetics and immunogenicity of LBEC0101 compared to Enbrel in subjects with active Rheumatoid Arthritis despite Methotrexate therapy.

开始日期2015-02-01

申办/合作机构

LG Life Sciences Ltd.

[+1]

100 项与依那西普生物类似药(Mochida Pharmaceutical Co., Ltd.) 相关的临床结果

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100 项与依那西普生物类似药(Mochida Pharmaceutical Co., Ltd.) 相关的转化医学

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100 项与依那西普生物类似药(Mochida Pharmaceutical Co., Ltd.) 相关的专利（医药）

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项与依那西普生物类似药(Mochida Pharmaceutical Co., Ltd.) 相关的文献（医药）

2021-12-01·Int. Journal of Clinical Pharmacology and Therapeutics4区 · 医学

Comparative efficacy and safety of etanercept biosimilars in comparison with etanercept in patients with rheumatoid arthritis who have insufficient response to methotrexate: A network meta-analysis

4区 · 医学

Article

作者: Lee, Young Ho ; Song, Gwan Gyu

OBJECTIVEWe aimed to assess the relative efficacy and safety of etanercept biosimilars and etanercept originators in patients with active rheumatoid arthritis (RA) who showed an inadequate response to methotrexate (MTX).MATERIALS AND METHODSWe performed a Bayesian network meta-analysis to combine direct and indirect evidence from randomized controlled trials (RCTs) examining the efficacy and safety of etanercept biosimilars vs. etanercept originators in patients with active RA despite treatment with MTX.RESULTSThree RCTs involving 1,200 patients, including 4 types of biologics, were included. Ranking probability based on the surface under the cumulative ranking curve (SUCRA) indicated that LBEC0101 had a high probability of being the better treatment in terms of the American College of Rheumatology 20 (ACR20) response rate (SUCRA = 0.744), followed by HD203 (SUCRA = 0.457), SB4 (SUCRA = 0.446), and etanercept (SUCRA = 0.352), although no difference in the ACR20 response rate between the biosimilars and etanercept groups was found. Although not statistically significant, there was a difference in the ranking probability of safety based on serious adverse events (SAEs) among interventions. Ranking probability based on SUCRA values indicated that LBEC0101 had the highest probability of being the safest treatment (SUCRA = 0.638), followed by SB4 (SUCRA = 0.495) and HD203 (SUCRA = 0.475), while etanercept had the lowest probability of being the safest treatment (SUCRA = 0.393).CONCLUSIONNo significant difference was found between etanercept biosimilars and etanercept originators in patients with active RA despite treatment with MTX in terms of the ACR20 response rate and SAEs.

2021-01-02·Expert Opinion on Biological Therapy3区 · 医学

LBEC0101, an etanercept biosimilar for the treatment of rheumatoid arthritis

3区 · 医学

Article

作者: Kim, Jinseok ; Song, Yeong Wook ; Park, Yong-Beom

Introduction: Treatment of rheumatoid arthritis (RA) has been revolutionized by the introduction of biologic disease-modifying antirheumatic drugs, such as tumor necrosis factor (TNF) inhibitors. With patent expiry approaching for many expensive biologic molecules, such as etanercept, more affordable biosimilar drugs are being developed. LBEC0101 is an etanercept biosimilar approved in Japan and South Korea for all etanercept indications including RA. Areas covered: We discuss the pharmacological characteristics, pharmacokinetics, efficacy, and safety of LBEC0101 compared with the etanercept reference product (ETN-RP). Preclinical studies showed that the binding affinity to TNFα and biological activity of LBEC0101 were similar to those of the ETN-RP. The pharmacokinetic profile of LBEC0101 was also similar to that of the ETN-RP. A Phase III, randomized, double-blind, 54-week study showed that the efficacy of LBEC0101 was equivalent to that of the ETN-RP in RA patients. An extension study showed that efficacy was sustained long-term in patients receiving LBEC0101 and in those switching from the ETN-RP to LBEC0101. The safety profile of LBEC0101 was also confirmed to be comparable with the ETN-RP. Expert opinion: LBEC0101 has shown equivalent pharmacokinetics and efficacy and comparable safety to the ETN-RP, and the lower cost of LBEC0101 provides a good cost-benefit ratio.

2020-02-01·BioDrugs3区 · 医学

Immunogenicity of Biosimilars for Rheumatic Diseases, Plaque Psoriasis, and Inflammatory Bowel Disease: A Review from Clinical Trials and Regulatory Documents

3区 · 医学

Review

作者: Strand, Vibeke ; Hickling, Timothy P ; Isaacs, John D ; Jones, Heather E ; Marshall, Lisa ; Gonçalves, Joao

The goal of this narrative review was to summarize immunogenicity data of biosimilars or biosimilar candidates for rheumatic diseases, plaque psoriasis, or inflammatory bowel disease (IBD), available in peer-reviewed publications or regulatory documents. PubMed records and regulatory documents were searched for immunogenicity data of TNFα or CD20 inhibitor biosimilars or biosimilar candidates. Data collected included the proportion of patients positive for anti-drug antibodies (ADAbs), proportion with neutralizing antibodies (nAbs) among ADAb-positive patients, ADAb/nAb assay characteristics, cross-reactivity, and the effects of ADAbs on pharmacokinetics, pharmacodynamics, efficacy, and safety. We identified eight biosimilars or biosimilar candidates for adalimumab (BI 695501, SB5, ABP 501, GP2017, PF-06410293, MSB-11022, FKB-327, ZRC-3197) four for etanercept (SB4, GP2015, CHS-0214, LBEC0101), and three each for infliximab (SB2, CT-P13, GP1111) and rituximab (CT-P10, GP2013, PF-05280586) with immunogenicity data. Randomized, head-to-head trials with reference products varied in design and methodology of ADAb/nAb detection. The lowest proportions of ADAb-positive (0-13%) and nAb-positive patients (0-3%) were observed in the trials of etanercept and its biosimilars, and the highest with adalimumab, infliximab, and their biosimilars (ADAbs: ≤ 64%; nAbs: ≤ 100%). The most common method of ADAb detection was electrochemiluminescence, and ADAb positivity was associated with nominally inferior efficacy and safety. Overall, there were no significant immunogenicity differences between biosimilars and reference products. However, there are many discrepancies in assessing and reporting clinical immunogenicity. In conclusion, immunogenicity data of biosimilars or biosimilar candidates for TNFα or CD20 inhibitors were collected in trials that varied in design and procedures for ADAb/nAb detection. In general, immunogenicity parameters of biosimilars are similar to those of their reference products.

100 项与依那西普生物类似药(Mochida Pharmaceutical Co., Ltd.) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	L04AB01	DB00005

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
幼年型关节炎	日本	Mochida Pharmaceutical Co., Ltd.	2018-01-19
类风湿关节炎	日本	Mochida Pharmaceutical Co., Ltd.	2018-01-19

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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


NCT02357069 (Phase III study for LBEC0101, EULAR2018)	临床3期	类风湿关节炎维持	148	LBEC0101	(糧餘廠壓蓋選壓範簾窪) = 壓鑰範窪積獵選夢艱鹽範顧願製糧鹹壓網網鬱 (蓋蓋醖憲鬱鏇選夢網顧 ) 更多	积极	2018-06-13
				ETN-RP	(糧餘廠壓蓋選壓範簾窪) = 構觸願餘積鏇餘製窪願範顧願製糧鹹壓網網鬱 (蓋蓋醖憲鬱鏇選夢網顧 ) 更多
NCT02715908 (Pubmed \| J Rheumatol) 人工标引	临床3期	类风湿关节炎	148	LBEC0101	(選壓範糧淵鹽積鑰範夢) = 觸窪獵構鏇範遞壓憲鹹製襯製餘餘蓋憲鬱觸壓 (淵鏇鬱願鑰醖餘鹹觸繭 ) 更多	优效	2019-05-21
				LBEC0101+etanercept	(選壓範糧淵鹽積鑰範夢) = 鏇顧鹽顧簾夢網窪願蓋製襯製餘餘蓋憲鬱觸壓 (淵鏇鬱願鑰醖餘鹹觸繭 ) 更多
NCT02357069 (Pubmed \| Arthritis Rheumatol)	临床3期	类风湿关节炎	374	LBEC0101	(選構鹹壓獵淵鏇膚繭壓) = 鬱範積淵艱鹹鬱願鹹選構範夢選齋蓋鑰製醖獵 (廠鹽繭憲壓醖範網繭壓 ) 更多	积极	2018-04-01
				Etanercept reference product (ETN-RP)	(選構鹹壓獵淵鏇膚繭壓) = 遞鏇選窪積餘簾鏇衊簾構範夢選齋蓋鑰製醖獵 (廠鹽繭憲壓醖範網繭壓 ) 更多