Eydenzelt
Aflibercept biosimilar developed by Celltrion, development code CT-P42. Reference product Eylea.
Brands by market: Eydenzelt (USA, EU) · Commercial partner or holder: Celltrion
FDAOct 2025approved
EMAFeb 2025authorised
CDSCOnot listed
EDEnot listed
Status by market
FDA
United States · Eydenzelt
US Food and Drug AdministrationApprovedBrand
Eydenzelt
Holder or applicant
CELLTRION, Inc.
Pathway
351(k)
Approved
Oct 2025
Application or permission
761377
Licence type
351(k) biosimilar, not interchangeable
Presentations
2 mg/0.05 mL vial
Source
S001, S016
EMA
European Union · Eydenzelt
European Medicines Agency and European CommissionApprovedBrand
Eydenzelt
Holder or applicant
Celltrion Healthcare Hungary Kft.
Pathway
Centralised (Article 10(4))
Approved
Feb 2025
Application or permission
EMEA/H/C/005899
Presentations
see SmPC
Source
S017
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- EMAFeb 2025Authorised by the European Commission as Eydenzelt
- FDAOct 2025Approved by FDA as Eydenzelt
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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