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 · Company profile
FDAMay 2024approved
EMASep 2023authorised
MHRALicenseddate not shown
PMDANot listed
HCJun 2025approved
CDSCOSep 2025permitted
EDENot listed
Approved or registered in 5 of 7 markets
Connections
About Yesafili
Yesafili is Biocon's aflibercept, the first aflibercept biosimilar approved in Europe, in September 2023, and one of the first two in the United States, in May 2024, where it was interchangeable from the start. Canada approved it in 2025, and Biocon holds an Indian import permission for it from the same year. It was originally developed with Mylan.
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
Reference product in the Purple Book
Eylea
Marketing status (Purple Book)
Prescription, marketed
Presentations
2 mg/0.05 mL vial and PFS
Remarks
One of the first two aflibercept biosimilars approved by FDA, interchangeable on licensure.
Source
S001 (FDA); S016 (FDA Purple Book) · checked Sep 2026
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
Remarks
First EU aflibercept biosimilar.
Source
S017 (EMA) · checked Sep 2026
MHRA
United Kingdom · Yesafili
Medicines and Healthcare products Regulatory AgencyApprovedBrand
Yesafili
Holder or applicant
Not shown in the MHRA substance list
Pathway
UK marketing authorisation (Great Britain and, for EU-converted licences, Northern Ireland)
Approved
not published
Presentations
40 mg/mL vial and syringe
Source
S023 (MHRA Products) · checked Sep 2026
PMDA
Japan
Not listed by PMDA.
HC
Canada · Yesafili
Health CanadaApprovedBrand
Yesafili
Holder or applicant
Biocon Biologics Canada INC
Pathway
Biosimilar biologic drug (Notice of Compliance)
Approved
Jun 2025
Application or permission
DIN 02535858, 02558238
Presentations
2 mg
Source
S022 (Health Canada) · checked Sep 2026
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 (CDSCO) · checked Sep 2026
EDE
United Arab Emirates
Not listed by EDE.
Other developers in the same markets
Where Yesafili holds an approval, these are the other aflibercept biosimilars approved in that market.
| Market | Rivals | Developers (product) |
|---|---|---|
| FDA | 5 | Amgen (Pavblu), Celltrion (Eydenzelt), Formycon (Ahzantive / Baiama), Samsung Bioepis (Opuviz), Sandoz (Enzeevu / Afqlir) |
| EMA | 8 | Alteogen (Eyluxvi), Alvotech (Afiveg / Mynzepli), Amgen (Pavblu), Celltrion (Eydenzelt), Formycon (Ahzantive / Baiama), Sam Chun Dang Pharm (Eiyzey / Vgenfli), Samsung Bioepis (Opuviz), Sandoz (Enzeevu / Afqlir) |
| MHRA | 7 | Alvotech (Afiveg / Mynzepli), Amgen (Pavblu), Celltrion (Eydenzelt), Formycon (Ahzantive / Baiama), Sam Chun Dang Pharm (Eiyzey / Vgenfli), Samsung Bioepis (Opuviz), Sandoz (Enzeevu / Afqlir) |
| HC | 4 | Amgen (Pavblu), Apotex (Aflivu), Celltrion (Eydenzelt), Sandoz (Enzeevu / Afqlir) |
| CDSCO | 1 | Zydus Lifesciences (Zydus aflibercept) |
Same developer, other molecules
Other biosimilars in the Atlas developed by Biocon Biologics: Biocon human insulin, Bosaya / Aukelso / Vevzuo / Evfraxy, Fulphila / Vivlipeg / Biopegfil, Jobevne / Abevmy / Krabeva, Kirsty, Ogivri / CANMAb, Semglee, Yesintek / Usrenty.
Chronology
- EMASep 2023Authorised by the European Commission as Yesafili
- FDAMay 2024Approved by FDA as Yesafili
- HCJun 2025Notice of Compliance, Health Canada 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)S022Health Canada, Drug Product Database data extract (active and inactive product files, biosimilar table) Primary (regulator)S023MHRA Products, substance lists of licensed medicines (products.mhra.gov.uk) Primary (regulator)
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