Pavblu
Aflibercept biosimilar developed by Amgen, development code ABP 938. Reference product Eylea.
Brands by market: Pavblu (USA, EU); Skojoy (EU, application withdrawn) · Commercial partner or holder: Amgen
FDAAug 2024approved
EMAApr 2025authorised
CDSCOnot listed
EDEnot listed
Status by market
FDA
United States · Pavblu
US Food and Drug AdministrationApprovedBrand
Pavblu
Holder or applicant
Amgen Inc.
Pathway
351(k)
Approved
Aug 2024
Application or permission
761298
Licence type
351(k) biosimilar, not interchangeable
Presentations
2 mg/0.05 mL vial and PFS
Note
First aflibercept biosimilar launched in the US, October 2024.
Source
S001, S016
EMA
European Union · Pavblu
European Medicines Agency and European CommissionApprovedBrand
Pavblu
Holder or applicant
Amgen Technology (Ireland) UC
Pathway
Centralised (Article 10(4))
Approved
Apr 2025
Application or permission
EMEA/H/C/006339
Presentations
see SmPC
Note
Authorisation date from the European Commission decision as reported; EMA's data table leaves it blank.
Source
S017
EMA
European Union · Skojoy
European Medicines Agency and European CommissionWithdrawnBrand
Skojoy
Holder or applicant
Amgen Technology (Ireland) UC
Pathway
Centralised (Article 10(4))
Approved
not published
Application or permission
EMEA/H/C/006551
Withdrawn
Mar 2025
Presentations
see SmPC
Note
Application withdrawn after opinion, 4 March 2025.
Source
S017
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- FDAAug 2024Approved by FDA as Pavblu
- EMAMar 2025Skojoy authorisation withdrawn
- EMAApr 2025Authorised by the European Commission as Pavblu
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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