Yesafili
Aflibercept biosimilar developed by Biocon Biologics (with Mylan / Viatris), development code MYL-1701P. Reference product Eylea.
Brands by market: Yesafili (USA, EU); import permission (India) · Commercial partner or holder: Biocon Biologics
FDAMay 2024approved
EMASep 2023authorised
CDSCOSep 2025permitted
EDEnot listed
Status by market
FDA
United States · Yesafili
US Food and Drug AdministrationApprovedBrand
Yesafili
Holder or applicant
Biocon Biologics Inc.
Pathway
351(k)
Approved
May 2024
Application or permission
761274
Licence type
351(k) interchangeable, designated May 2024
Presentations
2 mg/0.05 mL vial and PFS
Note
One of the first two aflibercept biosimilars approved by FDA, interchangeable on licensure.
Source
S001, S016
EMA
European Union · Yesafili
European Medicines Agency and European CommissionApprovedBrand
Yesafili
Holder or applicant
Biosimilar Collaborations Ireland Limited
Pathway
Centralised (Article 10(4))
Approved
Sep 2023
Application or permission
EMEA/H/C/006022
Indications as licensed
Wet AMD, DME, RVO, myopic CNV
Presentations
see SmPC
Note
First EU aflibercept biosimilar.
Source
S017
CDSCO
India · Yesafili
Central Drugs Standard Control OrganisationApprovedBrand
Yesafili
Holder or applicant
Biocon Biologics Limited
Pathway
Import and marketing permission
Approved
Sep 2025
Application or permission
IMP/BIO/25/000112
Indications as licensed
Wet AMD, DME, RVO macular oedema, myopic CNV
Presentations
40 mg/mL for intravitreal injection
Source
S012
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- EMASep 2023Authorised by the European Commission as Yesafili
- FDAMay 2024Approved by FDA as Yesafili
- CDSCOSep 2025CDSCO permission granted as Yesafili
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)S012CDSCO, new drugs (r-DNA origin) approved for import and marketing, Jan 2020 to June 2026 (CT-18) Primary (regulator)
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