Enzeevu / Afqlir
Aflibercept biosimilar developed by Sandoz. Reference product Eylea.
Brands by market: Enzeevu (USA); Afqlir (EU) · Commercial partner or holder: Sandoz
FDAAug 2024approved
EMANov 2024authorised
CDSCOnot listed
EDEnot listed
Status by market
FDA
United States · Enzeevu
US Food and Drug AdministrationApprovedBrand
Enzeevu
Holder or applicant
Sandoz Inc.
Pathway
351(k)
Approved
Aug 2024
Application or permission
761382
Licence type
351(k) biosimilar, not interchangeable
Presentations
2 mg/0.05 mL vial
Source
S001, S016
EMA
European Union · Afqlir
European Medicines Agency and European CommissionApprovedBrand
Afqlir
Holder or applicant
Sandoz GmbH
Pathway
Centralised (Article 10(4))
Approved
Nov 2024
Application or permission
EMEA/H/C/006150
Presentations
see SmPC
Source
S017
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- FDAAug 2024Approved by FDA as Enzeevu
- EMANov 2024Authorised by the European Commission as Afqlir
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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