Last update 29 May 2025

Bevacizumab biosimilar (Bio-Thera Solutions)

Overview

Basic Info

Drug Type
Biosimilar, Monoclonal antibody
Synonyms
Bevacizumab Biosimilar (Bio-Thera Solutions, Ltd.), BEVACIZUMAB-TNJN, 贝伐珠单抗生物类似药(百奥泰生物制药股份有限公司)
+ [5]
Target
Action
inhibitors
Mechanism
VEGF-A inhibitors(Vascular endothelial growth factor A inhibitors), Angiogenesis inhibitors
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
Regulation-
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Advanced Renal Cell Carcinoma
European Union
26 Jul 2024
Advanced Renal Cell Carcinoma
Iceland
26 Jul 2024
Advanced Renal Cell Carcinoma
Liechtenstein
26 Jul 2024
Advanced Renal Cell Carcinoma
Norway
26 Jul 2024
EGFR positive Non-squamous non-small cell lung cancer
European Union
26 Jul 2024
EGFR positive Non-squamous non-small cell lung cancer
Iceland
26 Jul 2024
EGFR positive Non-squamous non-small cell lung cancer
Liechtenstein
26 Jul 2024
EGFR positive Non-squamous non-small cell lung cancer
Norway
26 Jul 2024
Metastatic breast cancer
European Union
26 Jul 2024
Metastatic breast cancer
Iceland
26 Jul 2024
Metastatic breast cancer
Liechtenstein
26 Jul 2024
Metastatic breast cancer
Norway
26 Jul 2024
Metastatic Cervical Carcinoma
European Union
26 Jul 2024
Metastatic Cervical Carcinoma
Iceland
26 Jul 2024
Metastatic Cervical Carcinoma
Liechtenstein
26 Jul 2024
Metastatic Cervical Carcinoma
Norway
26 Jul 2024
metastatic non-small cell lung cancer
European Union
26 Jul 2024
metastatic non-small cell lung cancer
Iceland
26 Jul 2024
metastatic non-small cell lung cancer
Liechtenstein
26 Jul 2024
metastatic non-small cell lung cancer
Norway
26 Jul 2024
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
NeoplasmsPhase 3
United States
19 Dec 2019
NeoplasmsPhase 3
China
19 Dec 2019
NeoplasmsPhase 3
Japan
19 Dec 2019
NeoplasmsPhase 3
Australia
19 Dec 2019
NeoplasmsPhase 3
France
19 Dec 2019
NeoplasmsPhase 3
Italy
19 Dec 2019
NeoplasmsPhase 3
Malaysia
19 Dec 2019
NeoplasmsPhase 3
New Zealand
19 Dec 2019
NeoplasmsPhase 3
Poland
19 Dec 2019
NeoplasmsPhase 3
Taiwan Province
19 Dec 2019
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
94
(Arm A: Ociperlimab + Tislelizumab + BAT1706)
nuocncuksh = bndnbehykk ivntcktpan (kdscynjweh, vujokvlctq - yjdjkgntxr)
-
24 Feb 2025
(Arm B: Tislelizumab + BAT1706)
nuocncuksh = huiosauwah ivntcktpan (kdscynjweh, neerdvwher - nzypukiqig)
Phase 3
649
yxwmfhuuyx(jzjgbwgiyj) = emivxpfgvw ubclfacjrn (atlbmxtcmt )
Similar
01 Nov 2023
EU-bevacizumab
yxwmfhuuyx(jzjgbwgiyj) = vjnlrocqla ubclfacjrn (atlbmxtcmt )
Phase 2
94
ozazfksjvh(jqrgkmcpzt) = bhwtlcmugh kgsrsxmfhl (eewuwvdqws, 23.7 - 48.7)
Positive
21 Oct 2023
ozazfksjvh(jqrgkmcpzt) = tejezltmpw kgsrsxmfhl (eewuwvdqws, 21.1 - 56.3)
Phase 3
651
carboplatin+Paclitaxel+EU Avastin®
(EU Avastin®)
bygpsahcko = kixmnyrjfi yigszcssao (fnmjhrpdtd, emdxxjiuye - tsbbqbuwwv)
-
13 Sep 2021
bygpsahcko = bfgsclnzct yigszcssao (fnmjhrpdtd, rtniutkhfj - fzxouzzhwf)
Phase 1
-
128
uvsrefrrrd(wctaindvuj) = 99-112% for BAT1706 versus EU-BEV, 97-110% for BAT1706 vs US-BEV and 92-104% for EU-BEV versus US-BEV comparisons, respectively, demonstrating biosimilarity. zwuadxucgs (idglbqipzi )
Positive
01 Jun 2019
Pubmed
ManualManual
Phase 1
-
-
sahexltjox(yynzjnuiki) = Bevacizumab demonstrated linear PK properties and a concentration-dependent disposition. When comparing the three biosimilars with bevacizumab-EU, the 90% CIs of the ratios for Cmax, AUC0-t, and AUC0-∞ were within 80-125%. The inter-CV ranged from 12.6 to 23.3%. booupiwatu (pdbnjadlmf )
Positive
01 Oct 2018
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Core Patent

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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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