Home/Biosimilar Atlas/Bevacizumab/Aybintio

Aybintio

Bevacizumab biosimilar developed by Samsung Bioepis, development code SB8. Reference product Avastin.

Brands by market: Aybintio (EU); Onbevzi (EU, withdrawn) · Commercial partner or holder: Samsung Bioepis · Company profile
FDANot listed
EMAAug 2020authorised
MHRALicenseddate not shown
PMDANot listed
HCNov 2021approved
CDSCONot listed
EDENot listed
Approved or registered in 3 of 7 markets
Connections
BevacizumabmoleculeSamsung Bioepisdeveloper3 of 7markets2trials behind it9other products, same developer8rival developers in its markets

About Aybintio

Aybintio is Samsung Bioepis's bevacizumab, approved in Europe in 2020 and in Canada in 2021. A second European name, Onbevzi, was approved in early 2021 and later withdrawn. It has not been filed in the United States, one of the few Samsung Bioepis biosimilars not to be.

Status by market

FDA

United States

Not listed by FDA.

EMA

European Union · Aybintio

European Medicines Agency and European CommissionApproved
Brand
Aybintio
Holder or applicant
Samsung Bioepis NL B.V.
Pathway
Centralised (Article 10(4))
Approved
Aug 2020
Application or permission
EMEA/H/C/005106
Presentations
see SmPC
Source
S017 (EMA) · checked Sep 2026
EMA

European Union · Onbevzi

European Medicines Agency and European CommissionWithdrawn
Brand
Onbevzi
Holder or applicant
Samsung Bioepis NL B.V.
Pathway
Centralised (Article 10(4))
Approved
Jan 2021
Application or permission
EMEA/H/C/005640
Withdrawn
date not published
Presentations
see SmPC
Remarks
Duplicate authorisation, withdrawn.
Source
S017 (EMA) · checked Sep 2026
MHRA

United Kingdom · Aybintio

Medicines and Healthcare products Regulatory AgencyApproved
Brand
Aybintio
Holder or applicant
Not shown in the MHRA substance list
Pathway
UK marketing authorisation (Great Britain and, for EU-converted licences, Northern Ireland)
Approved
not published
Presentations
25 mg/mL vials
Source
S023 (MHRA Products) · checked Sep 2026
PMDA

Japan

Not listed by PMDA.

HC

Canada · Aybintio

Health CanadaApproved
Brand
Aybintio
Holder or applicant
Samsung Bioepis CO., LTD
Pathway
Biosimilar biologic drug (Notice of Compliance)
Approved
Nov 2021
Application or permission
DIN 02522829, 02522837
Presentations
100, 400 mg
Source
S022 (Health Canada) · checked Sep 2026
CDSCO

India

Not listed by CDSCO.

EDE

United Arab Emirates

Not listed by EDE.

Trials behind this product

Comparative trials on ClinicalTrials.gov matched to Aybintio by development code, brand or developer. Registry data, sponsor-entered.

CandidateDeveloper or sponsorReference productPhaseDesignRegistry statusStartedPrimary completionRegistry record
SB8Samsung BioepisAvastinPhase 1Comparative PKCompletedApr 2015Sep 2015NCT02453672
SB8Samsung BioepisAvastinPhase 3Comparative efficacyCompletedJul 2016Jan 2018NCT02754882

Other developers in the same markets

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

MarketRivalsDevelopers (product)
EMA6Amgen (Mvasi), Bio-Thera Solutions (Avzivi), Biocon Biologics (Jobevne / Abevmy / Krabeva), Celltrion (Vegzelma), Pfizer (Zirabev), mAbxience (Alymsys / Oyavas)
MHRA5Biocon Biologics (Jobevne / Abevmy / Krabeva), Celltrion (Vegzelma), Not stated in the MHRA list (Versavo), Pfizer (Zirabev), mAbxience (Alymsys / Oyavas)
HC5Amgen (Mvasi), Apotex (Bambevi), Biocon Biologics (Jobevne / Abevmy / Krabeva), Celltrion (Vegzelma), Pfizer (Zirabev)

Same developer, other molecules

Other biosimilars in the Atlas developed by Samsung Bioepis: Byooviz, Epysqli, Eticovo / Benepali, Hadlima / Imraldi, Ontruzant, Opuviz, Ospomyv / Xbryk / Obodence, Pyzchiva, Renflexis / Flixabi.

Chronology

Sources

All bevacizumab biosimilars

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Data current to September 2026.