Last update 21 Nov 2024

Tocilizumab-bavi

Overview

Basic Info

Drug Type
Biosimilar, Monoclonal antibody
Synonyms
Tocilizumab biosimilar (Bio-Thera Solutions), 重组人源化抗人白介素6受体单抗 (百奥泰生物)
+ [4]
Target
Mechanism
IL-6RA antagonists(Interleukin-6 receptor alpha subunit antagonists)
Inactive Indication-
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
Regulation-
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External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
COVID-19
IS
20 Jun 2024
COVID-19
NO
20 Jun 2024
COVID-19
EU
20 Jun 2024
COVID-19
LI
20 Jun 2024
Oligoarticular Arthritis
IS
20 Jun 2024
Oligoarticular Arthritis
NO
20 Jun 2024
Oligoarticular Arthritis
LI
20 Jun 2024
Oligoarticular Arthritis
EU
20 Jun 2024
Polyarticular Juvenile Idiopathic Arthritis
US
29 Sep 2023
Cytokine Release Syndrome
CN
16 Jan 2023
Rheumatoid Arthritis
CN
16 Jan 2023
Systemic onset juvenile chronic arthritis
CN
16 Jan 2023
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Juvenile Idiopathic ArthritisNDA/BLA
US
09 Dec 2022
Rheumatoid ArthritisNDA/BLA
US
09 Dec 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
-
138
(iwqdhquonj) = similar in all three groups: BAT1806 (n = 45), RoActemra-EU (n = 42), and Actemra-US (n = 42). The 90% confidence intervals (CIs) for the ratios of C max , AUC0-t and AUC0-∞ were 86.90-104.41% for BAT1806 vs. RoActemra-EU, 91.70-106.15% for BAT1806 vs Actemra-US, and 90.04-105.53% for Actemra-US vs RoActemra-EU. For all comparisons, the 90% CIs for the C max , AUC0-t , and AUC0-∞ were within the predefined bioequivalence limit of 80.00-125.00%. hlrmokfval (akdylsjexe )
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01 Jan 2020
RoActemra-EU
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Regulation

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