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) · Company profile
FDADec 2023approved
EMAJul 2024authorised
MHRANot listed
PMDANot listed
HCNot listed
CDSCONot listed
EDENot listed
Approved or registered in 2 of 7 markets

About Avzivi

Avzivi is the bevacizumab developed by Bio-Thera Solutions of China and sold by Sandoz. The United States approved it in December 2023 and Europe in July 2024, where the licence is held through a representative company on Bio-Thera's behalf. It was one of the first Chinese-developed antibodies approved in both markets.

Status by market

FDA

United States · Avzivi

US Food and Drug AdministrationApproved
Brand
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
Reference product in the Purple Book
Avastin
Marketing status (Purple Book)
Prescription, marketed
Presentations
100 mg/4 mL, 400 mg/16 mL
Source
S001 (FDA); S016 (FDA Purple Book) · checked Sep 2026
EMA

European Union · Avzivi

European Medicines Agency and European CommissionApproved
Brand
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
Remarks
Bio-Thera product; Sandoz commercialises in the EU.
Source
S017 (EMA) · checked Sep 2026
MHRA

United Kingdom

Not listed by MHRA.

PMDA

Japan

Not listed by PMDA.

HC

Canada

Not listed by HC.

CDSCO

India

Not listed by CDSCO.

EDE

United Arab Emirates

Not listed by EDE.

Other developers in the same markets

Where Avzivi holds an approval, these are the other bevacizumab biosimilars approved in that market.

MarketRivalsDevelopers (product)
FDA5Amgen (Mvasi), Biocon Biologics (Jobevne / Abevmy / Krabeva), Celltrion (Vegzelma), Pfizer (Zirabev), mAbxience (Alymsys / Oyavas)
EMA6Amgen (Mvasi), Biocon Biologics (Jobevne / Abevmy / Krabeva), Celltrion (Vegzelma), Pfizer (Zirabev), Samsung Bioepis (Aybintio), mAbxience (Alymsys / Oyavas)

Same developer, other molecules

Other biosimilars in the Atlas developed by Bio-Thera Solutions: Starjemza, Tofidence / Tocilizumab STADA.

Chronology

Sources

All bevacizumab biosimilars

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Data current to September 2026.