Opuviz
Aflibercept biosimilar developed by Samsung Bioepis, development code SB15. Reference product Eylea.
Brands by market: Opuviz (USA, EU) · Commercial partner or holder: Biogen (USA, EU)
FDAMay 2024approved
EMANov 2024authorised
CDSCOnot listed
EDEnot listed
Status by market
FDA
United States · Opuviz
US Food and Drug AdministrationApprovedBrand
Opuviz
Holder or applicant
Samsung Bioepis Co., Ltd.
Pathway
351(k)
Approved
May 2024
Application or permission
761350
Licence type
351(k) interchangeable, designated May 2024
Presentations
2 mg/0.05 mL vial and PFS
Source
S001, S016
EMA
European Union · Opuviz
European Medicines Agency and European CommissionApprovedBrand
Opuviz
Holder or applicant
Samsung Bioepis NL B.V.
Pathway
Centralised (Article 10(4))
Approved
Nov 2024
Application or permission
EMEA/H/C/006056
Presentations
see SmPC
Source
S017
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- FDAMay 2024Approved by FDA as Opuviz
- EMANov 2024Authorised by the European Commission as Opuviz
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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