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

CTRI/2017/10/010206 / Completed临床3期

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-

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100 项与贝伐珠单抗生物类似药(Biocad Medical, Inc.) 相关的转化医学

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

AbstractBackgroundBCD-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).MethodsPatients 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%].ResultsIn 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.ConclusionsThus, the results of this study demonstrated therapeutic equivalence of bevacizumab biosimilar BCD-021 and referent bevacizumab drug.Trial registrationThe trial was registered with ClinicalTrials.gov (Study Number NCT01763645, date of registration 09/01/2013).

2013-02-01·Experimental Biology and Medicine4区 · 医学

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

4区 · 医学

Article

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

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.

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

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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KEGG	Wiki	ATC	Drug Bank
-	贝伐珠单抗生物类似药(Biocad Medical, Inc.)	L01XC07	-

研发状态

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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

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适应症	最高研发状态	国家/地区	公司	日期
湿性年龄相关性黄斑变性	临床1期	-	Biocad CJSC	2015-05-21
非小细胞肺癌	临床1期	白俄罗斯	Biocad Medical, Inc.	2012-10-01
非小细胞肺癌	临床1期	乌克兰	Biocad Medical, Inc.	2012-10-01
非小细胞肺癌	临床1期	印度	Biocad Medical, Inc.	2012-10-01
实体瘤	临床申请	中国	上药帛康生物医药（上海）有限公司	2022-07-02
实体瘤	临床申请	中国	Biocad Medical, Inc.	2022-07-02
结直肠癌	临床前	中国	上海医药集团股份有限公司	2022-07-20