Avzivi
Bevacizumab biosimilar developed by Bio-Thera Solutions, development code BAT1706. Reference product Avastin.
Brands by market: Avzivi (USA, EU) · Commercial partner or holder: Sandoz (USA, EU)
FDADec 2023approved
EMAJul 2024authorised
CDSCOnot listed
EDEnot listed
Status by market
FDA
United States · Avzivi
US Food and Drug AdministrationApprovedBrand
Avzivi
Holder or applicant
Bio-Thera Solutions, Ltd.
Pathway
351(k)
Approved
Dec 2023
Application or permission
761198
Licence type
351(k) biosimilar, not interchangeable
Presentations
100 mg/4 mL, 400 mg/16 mL
Source
S001, S016
EMA
European Union · Avzivi
European Medicines Agency and European CommissionApprovedBrand
Avzivi
Holder or applicant
FGK Representative Service GmbH
Pathway
Centralised (Article 10(4))
Approved
Jul 2024
Application or permission
EMEA/H/C/005574
Presentations
see SmPC
Note
Bio-Thera product; Sandoz commercialises in the EU.
Source
S017
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- FDADec 2023Approved by FDA as Avzivi
- EMAJul 2024Authorised by the European Commission as Avzivi
Sources
S001FDA, Biosimilar Product Information (approved biosimilars table) Primary (regulator)S016FDA Purple Book, monthly data downloads January to August 2026 Primary (regulator)S017EMA, medicines data table (medicines-output-medicines-report_en.xlsx) Primary (regulator)
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