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Brands by market: Aybintio (EU); Onbevzi (EU, withdrawn) · Commercial partner or holder: Samsung Bioepis
FDAnot listed
EMAAug 2020authorised
CDSCOnot listed
EDEnot listed
Status by market
FDA
United States
Not listed by FDA.
EMA
European Union · Aybintio
European Medicines Agency and European CommissionApprovedBrand
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
European Union · Onbevzi
European Medicines Agency and European CommissionWithdrawnBrand
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Withdrawn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
Note
Duplicate authorisation, withdrawn.
Source
S017
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- EMAAug 2020Authorised by the European Commission as Aybintio
Sources
S017EMA, medicines data table (medicines-output-medicines-report_en.xlsx) Primary (regulator)
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