International multicenter randomized double blind phase III trial comparing safety and efficacy of BCD-021 (CJSC BIOCAD, Russia) and Paclitaxel + carboplatin to AvastinÂ® (F. Hoffmann-La Roche Ltd, Switzerland)and paclitaxel + carboplatin in inoperable or advanced non-squamous non-small-cell lung cancer (NSCLC) patients

开始日期2017-11-20

申办/合作机构-

NCT02450981 / Withdrawn临床1期

Multicentre Open Label Non-randomized Clinical Study Evaluating Pharmacokinetics, Safety, Tolerability of Multiple Intravitreal Injections of BCD-021 (CJSC BIOCAD, Russia) in Patients With Neovascular Wet Age-related Macular Degeneration

This clinical study is a phase 1 study which carried out to to evaluate the safety, pharmacokinetics and tolerability of multiple intravitreal injections of BCD-021(bevacizumab biosimilar candidate manufactured by CJSC BIOCAD, Russia) when used in patients with neovascular wet age-related macular degeneration.

开始日期-

申办/合作机构

Biocad CJSC

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项与贝伐珠单抗生物类似药(Biocad Medical, Inc.) 相关的文献（医药）

2022-12-01·BMC cancer2区 · 医学

Randomized double-blind clinical trial comparing safety and efficacy of the biosimilar BCD-021 with reference bevacizumab

2区 · 医学

ArticleOA

作者: Matrosova, Marina P ; Kryukov, Fedor ; Adamchuk, Grigoriy A ; Shustova, Mariya S ; Shelepen, Konstantin G ; Kalloli, Mahesh ; Fadeeva, Natalya V ; Nagarkar, Rajnish ; Zhuravleva, Daria ; Voevodin, Georgiy D ; Roy, Bodhisatta ; Stroyakovskiy, Daniil L

Abstract:

Background:

BCD-021 is a bevacizumab biosimilar which was shown to be equivalent to reference bevacizumab in a wide panel of physicochemical studies as well as preclinical studies in vitro and in vivo. International multicenter phase III clinical trial was conducted to compare efficacy and safety of BCD-021 and reference bevacizumab in combination with paclitaxel and carboplatin in a first-line treatment of inoperable or advanced non-squamous non-small-cell lung cancer (NSCLC).

Methods:

Patients with no previous treatment for advanced non-squamous NSCLC were randomly assigned 3:2 to BCD-021 or reference bevacizumab and were treated with bevacizumab + paclitaxel + carboplatin. Therapy continued for 6 cycles (every 3 weeks), until progression of the disease or unbearable toxicity. The primary study endpoint was the overall response rate. The study goal was to prove the equivalent efficacy of BCD-021 and reference bevacizumab. Equivalence margins for 95% CI for the difference in the overall response rates were set at [-18%; 18%], for 90% CI for the ratio of overall response rate were set at [67%; 150%].

Results:

In total 357 patients were enrolled in the study, 212 in the BCD-021 group and 145 in the reference bevacizumab group. The ORR was 34.63% in the BCD-022 group and 33.82% in the reference bevacizumab group. Limits of 95% CI for the difference in overall response rates between the groups were [-9.47%; 11.09%]. Limits of 90% CI for the ratio of overall response rate between the groups were [79.6%; 131.73%]. For both approaches CI lied within predetermined equivalence margins. Profile of adverse events (AEs) was similar between the groups (any AEs were reported in 86.89% of patients in BCD-021 group and 89.05% of patients in reference group). No unexpected adverse reactions were reported throughout the study. No statistically significant differences regarding anti-drug antibody occurrence rate was found between BCD-022 (n=4; 1.96%) and comparator (n=5; 3.65%). Both drug products showed low occurrence rate and short life of anti-bevacizumab antibodies. Pharmacokinetics assessment after 1st and 6th study drug injection also demonstrated equivalent PK parameters by all outcome measures.

Conclusions:

Thus, the results of this study demonstrated therapeutic equivalence of bevacizumab biosimilar BCD-021 and referent bevacizumab drug.

Trial registration:

The trial was registered with ClinicalTrials.gov (Study Number NCT01763645, date of registration 09/01/2013).

2013-02-01·Experimental biology and medicine (Maywood, N.J.)4区 · 医学

Identification and differential expression of human carcinoma-associated antigens in hepatocellular carcinoma tissues

4区 · 医学

Article

作者: Qu, Hai-Xia ; Tan, Ye-Xiong ; Wang, Hao ; Zou, Shan-Shan ; Wang, Hong-Yang ; Hong, Yi ; Zheng, Long-Yi ; Yu, Feng-Hai ; Hu, He-Ping ; Zhou, Dong-Xun

This study was designed to identify and verify hepatocellular carcinoma (HCC)-associated human carcinoma antigens (HCAs) that may be useful as tumor markers for HCC. We found that BCE075 and BCD021 anti-HCA antibodies were immunostained in the liver tissue samples and showed specific staining. Their expression was increased in HCC compared with normal liver tissues ( P = 0.008). Immunoprecipitation and mass spectrometry analyses of the proteins precipitated by these two antibodies were identified to be cytoskeleton-associated protein 4 (CLIMP63) and brain-type glycogen phosphorylase (PYGB). This study demonstrated that HCC tissues expressed specific HCA glycoproteins, suggesting that our mouse monoclonal anti-HCA antibodies could be useful for immunohistochemical analysis of HCA expression as potential biomarkers for HCC diagnosis.

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2021-04-14

·GlobeNewswire

New York, April 14, 2021 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Global Biosimilar Monoclonal Antibodies Forecast 2020-2030" - • Along with revenue prediction for the overall world market for biosimilar monoclonal antibodies, our investigation shows forecasts to 2027 for the market segmented by compound: • Infliximab • Rituximab • Abciximab • Trastuzumab • Adalimumab • Bevacizumab • This report also shows revenue to 2027 for individual biosimilar mAb products in the market: • Remsima/Inflectra • Infimab • Reditux • BI695500 • CT-P10 • BI695501 • FKB327 • FKB238 • Mabtas • AcellBia • Maball • Clotinab • Abcixirel • BCD-022 • BCD-021 • Herzuma • CANMAB/Hertraz • Our analyses show individual revenue forecasts to 2027 for these regional and national markets: • The US Biosimilar mAb Market • Japanese Biosimilar mAb Market • EU5 Biosimilar mAb Markets • BRIC and South Korea Biosimilar mAb Markets • Rest of the World Biosimilar mAb Market • This report profiles 10 leading companies either with biosimilar mAbs already on the market or in the pipeline • Our study discusses strengths, weaknesses, opportunities and threats affecting the biosimilar monoclonal antibodies market Read the full report: About Reportlinker ReportLinker is an award-winning market research solution. Reportlinker finds and organizes the latest industry data so you get all the market research you need - instantly, in one place. __________________________

生物类似药抗体

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-	贝伐珠单抗生物类似药(Biocad Medical, Inc.)	L01XC07	-

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适应症	国家/地区	公司	日期
结直肠癌	俄罗斯	Biocad Medical, Inc.	2015-11-25
胶质母细胞瘤	俄罗斯	Biocad Medical, Inc.	2015-11-25
非小细胞肺癌	俄罗斯	Biocad Medical, Inc.	2015-11-25
卵巢上皮癌	俄罗斯	Biocad Medical, Inc.	2015-11-25
肾细胞癌	俄罗斯	Biocad Medical, Inc.	2015-11-25