利妥昔单抗生物类似药(Biocad Medical, Inc.)(Rituximab biosimilar(Biocad Medical, Inc.)) - 药物靶点：CD20_在研适应症：慢性淋巴细胞白血病，非霍奇金淋巴瘤_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

AcellBia、Rituximab biosimilar、USMAL

+ [1]

靶点

CD20

作用机制

CD20抑制剂(B淋巴细胞抗原CD20抑制剂)、ADCC(抗体依赖的细胞毒作用)、CD20定向的溶细胞作用

+ [1]

治疗领域

肿瘤免疫系统疾病血液及淋巴系统疾病

在研适应症

慢性淋巴细胞白血病非霍奇金淋巴瘤

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-

最高研发阶段批准上市

首次获批日期

俄罗斯 (2015-01-01),

慢性淋巴细胞白血病非霍奇金淋巴瘤

最高研发阶段(中国)-

特殊审评-

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序列信息

Sequence Code 83181H

当前序列信息引自: *****

Sequence Code 27145L

当前序列信息引自: *****

关联

2

项与利妥昔单抗生物类似药(Biocad Medical, Inc.) 相关的临床试验

NCT02744196 / Completed临床3期

Multicenter Comparative Randomised Double-blind Placebo-controlled Clinical Trial to Evaluate Efficacy and Safety of Acellbia® (JSC "BIOCAD") With Methotrexate in First Line of Biological Therapy of Patients With Active Rheumatoid Arthritis

The mail goal of this study is to establish superiority in efficacy of Acellbia® applied in a dose of 600 mg (Day 1 and Day 15) in combination with methotrexate in patients with active RA seropositive previously untreated with biological therapy, compared to standard therapy with methotrexate.

开始日期2015-01-01

申办/合作机构

Biocad CJSC

NCT01701232 / Completed临床3期

A Multicenter Open-label Randomized Study of BCD-020 (Rituximab, CJSC BIOCAD, Russia) Efficacy and Safety in Comparison With MabThera (F. Hoffmann-La Roche Ltd., Switzerland) in Monotherapy of CD20-positive Indolent Non-Hodgkin's Lymphoma

This international multi-center, randomized, controlled, open-label study investigated the pharmacokinetics, pharmacodynamics, efficacy and safety of BCD-020 (INN: rituximab, CJSC Biocad) versus MabThera® (INN: rituximab, F. Hoffmann La Roche, Ltd.) both administered as a monotherapy of patients with indolent non-Hodgkin's lymphoma.
Patients were randomized to receive 375 mg/m² BCD-020 as intravenous infusion once a week for 4 weeks or MabThera® at the same regimen.

开始日期2011-09-01

申办/合作机构

Biocad CJSC

100 项与利妥昔单抗生物类似药(Biocad Medical, Inc.) 相关的临床结果

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100 项与利妥昔单抗生物类似药(Biocad Medical, Inc.) 相关的转化医学

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100 项与利妥昔单抗生物类似药(Biocad Medical, Inc.) 相关的专利（医药）

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6

项与利妥昔单抗生物类似药(Biocad Medical, Inc.) 相关的文献（医药）

2023-05-22·Biomedicines

Rituximab Biosimilar BCD020 Shows Superior Efficacy above Conventional Non-Biologics Treatment in Pediatric Lupus Nephritis: The Data of Retrospective Cohort Study.

Article

作者: Kalashnikova, Elvira ; Snegireva, Ludmila ; Masalova, Vera ; Suspitsin, Evgeny ; Chasnyk, Vyacheslav ; Abramova, Natalia ; Kalashnikova, Olga ; Kuchuinskaya, Ekaterina ; Gaidar, Ekaterina ; Kaneva, Maria ; Sorokina, Lubov ; Lubimova, Natalia ; Dubko, Margarita F ; Kostik, Mikhail ; Rinat, Raupov ; Isupova, Eugenia ; Soloviev, Anton A ; Kornishina, Tatyana

BACKGROUNDPediatric lupus nephritis (LN) is one of the most serious manifestations of systemic lupus erythematosus (SLE) in children, determining the outcomes of the disease. There are no standardized treatment protocols for pediatric LN, and the role of biologics has not yet been conclusively defined.OBJECTIVESanalyze the safety and efficacy of rituximab biosimilar BCD020 in pediatric patients with lupus nephritis.METHODSin a retrospective cohort study, the data from the case histories of 25 patients with LN (10 boys and 15 girls) with an onset age of 13 (9-16) years, who failed conventional non-biologic treatment or developed corticosteroid dependence/toxicity, were included. The diagnosis was made using Systemic Lupus International Collaborating Clinics (SLICC) classification criteria. Rituximab biosimilar BCD020 was prescribed in a dosage of 375 mg/m² every week (2-4 infusions) with repeated courses every 6-12 months (2-4 infusions) according to disease activity, B-cell depletion, and IgG levels. The dynamics of clinical and laboratory data, the activity of the disease by SLEDAI, and corticosteroid doses were assessed at the onset and during the rituximab trial.RESULTSThe main patient's characteristics were: Pre-rituximab non-biologic conventional treatment included: cyclophosphamide 15 (60%), MMF 8 (32%), azathioprine 3 (12%), hydroxychloroquine 12 (48%), and pulse therapy of methylprednisolone followed by oral methylprednisolone 25 (100%). The time before rituximab was 7.0 (3.0-24.0) months, and the whole observation period was 7.0 (0; 24) months. The initial pre-rituximab treatment slightly reduced SLEDAI levels and the proportion of patients with LN. A significant reduction of SLEDAI, the anti-dsDNA level, proteinuria, hematuria, C4 complement, ESR, and the median corticosteroid dose by 80% from the initial value, as well as the proportion of patients without corticosteroids, was observed after rituximab administration. Two deaths were observed due to catastrophic SLE with macrophage activation syndrome, accompanied by a severe infection (invasive aspergillosis, n = 2). Three patients developed serious adverse events: pneumonia (n = 2), transient agranulocytosis (n = 1) after the third rituximab infusion, and meningitis, caused by Listeria monocytosis, after the first rituximab infusion. Eight patients received antibacterial treatment for different respiratory infections without hospital admissions.CONCLUSIONSRituximab biosimilar BCD020 showed effectiveness in LN, whereas previous non-biologic treatment was insufficiently effective. Randomized controlled trials are required to evaluate the efficacy and safety of rituximab and evaluate the benefits when compared with conventional SLE treatment.

2020-02-01·Hematological Oncology3区 · 医学

Proposed rituximab biosimilar BCD‐020 versus reference rituximab for treatment of patients with indolent non‐Hodgkin lymphomas: An international multicenter randomized trial

3区 · 医学

Article

作者: Ivanov, Roman A. ; Bermúdez, Carlos D. ; Attili, V. Satya Suresh ; Poddubnaya, Irina V. ; Rekhtman, Grigoriy B. ; Chernyaeva, Ekaterina V. ; Alekseev, Sergey M. ; Lukavetskyy, Les M. ; Kaplanov, Kamil D. ; Isaev, Aleksandr A. ; Dolai, Tuphan K.

AbstractBCD‐020 is a proposed rituximab biosimilar, which has shown high similarity to rituximab in quality and nonclinical studies in vitro and in vivo.International multicenter clinical trial was conducted to compare efficacy and safety of BCD‐020 and reference rituximab in adult (older than 18 years) patients with indolent lymphomas (follicular lymphoma grade 1‐2, splenic marginal zone lymphoma, and nodal marginal zone lymphoma). Pharmacokinetics, pharmacodynamics, and immunogenicity were also studied.Patients with no previous biologic treatment for lymphoma were randomly assigned 1:1 to receive BCD‐020 or comparator 375 mg/m2 for 4 weeks.Primary study outcome was day 50 overall response rate defined as complete or partial remission. Equivalence range was −20% to 20% for 95% CI for overall response rates difference. Secondary outcomes included adverse events, pharmacokinetics, pharmacodynamics, and immunogenicity.One hundred seventy‐four patients were enrolled, 89 in BCD‐020 arm and 85 in comparator arm. The overall response rate was 44.71% in BCD‐020 arm and 41.89% in comparator arm. Limits of 95% confidence interval (CI) for difference of overall response rates between arms were (−12.62%‐18.24%) showing equivalent efficacy. Sixty‐one (68.54%) and 59 (69.41%) patients had at least one adverse event in BCD‐020 arm or comparator arm, respectively. No unexpected adverse reactions were reported.Antidrug antibodies with no neutralizing activity were detected in two patients in comparator arm on day 14 further declining below detection threshold.Rituximab concentrations had equivalent pattern after intravenous administration of both drugs. Both drugs caused depletion of B‐cells without significant influence on other blood cell lineages.In this study, we showed equivalent efficacy of BCD‐020 and reference rituximab when used in patients with CD20‐positive indolent lymphomas. We also confirmed pharmacokinetic equivalence of BCD‐020 and reference rituximab. Safety profile, pharmacodynamics, and immunogenicity of BCD‐020 were also comparable with those of reference rituximab.

2020-01-01·European Journal of Pharmaceutics and Biopharmaceutics2区 · 医学

Multifaceted assessment of rituximab biosimilarity: The impact of glycan microheterogeneity on Fc function

2区 · 医学

Article

作者: Kang, Jukyung ; Schwendeman, Anna ; Sen, K Ilker ; Schwendeman, Steven P ; Coghlan, Jill ; Ford, Michael ; Ruotolo, Brandon T ; Hageman, Tyler S ; White, Derek R ; Benet, Alexander ; Weis, David D ; Saveliev, Sergei ; Kim, Sang Yeop ; Vallejo, Daniel ; Tolbert, Thomas J

Biosimilars are poised to reduce prices and increase patient access to expensive, but highly effective biologic products. However, questions still remain about the degree of similarity and scarcity of information on biosimilar products from outside of the US/EU in the public domain. Thus, as an independent entity, we performed a comparative analysis between the innovator, Rituxan® (manufactured by Genentech/Roche), and a Russian rituximab biosimilar, Acellbia® (manufactured by Biocad). We evaluated biosimilarity of these two products by a variety of state-of-the-art analytical mass spectrometry techniques, including tandem MS mapping, HX-MS, IM-MS, and intact MS. Both were found to be generally similar regarding primary and higher order structure, though differences were identified in terms of glycoform distribution levels of C-terminal Lys, N-terminal pyroGlu, charge variants and soluble aggregates. Notably, we confirmed that the biosimilar had a higher level of afucosylated glycans, resulting in a stronger FcγIIIa binding affinity and increased ADCC activity. Taken together, our work provides a comprehensive comparison of Rituxan® and Acellbia®.

100 项与利妥昔单抗生物类似药(Biocad Medical, Inc.) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	L01XC02	-

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
慢性淋巴细胞白血病	俄罗斯	Biocad Medical, Inc.	2015-01-01
非霍奇金淋巴瘤	俄罗斯	Biocad Medical, Inc.	2015-01-01

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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


EULAR2016	临床3期	类风湿关节炎	160	BCD-020	(鏇願鹹衊壓壓襯構蓋窪) = 膚壓鏇積蓋淵醖醖醖餘鹹醖簾膚蓋鹹網艱膚鹽 (鏇觸窪衊膚構簾築廠壓 )	-	2016-06-08
				Innovator RTX	(鏇願鹹衊壓壓襯構蓋窪) = 網壓鹽憲鏇製鹹選網窪鹹醖簾膚蓋鹹網艱膚鹽 (鏇觸窪衊膚構簾築廠壓 )
EULAR2022	N/A	系统性硬化相关的间质性肺病	62	Mabthera	(顧憲襯鹽廠製繭範齋廠) = 構選淵齋艱積鑰鑰衊觸憲醖觸願願壓鑰鏇糧窪 (鏇壓築膚憲構齋獵簾觸, 67.5[42.5 ~ 10 to 91]) 更多	-	2022-06-01
				Acellbia	(顧憲襯鹽廠製繭範齋廠) = 糧網糧製鏇蓋憲鹹糧壓憲醖觸願願壓鑰鏇糧窪 (鏇壓築膚憲構齋獵簾觸, 42.6[52.5 ~ 13 to 90]) 更多