Eydenzelt
Aflibercept biosimilar developed by Celltrion, development code CT-P42. Reference product Eylea.
Brands by market: Eydenzelt (USA, EU) · Commercial partner or holder: Celltrion · Company profile
FDAOct 2025approved
EMAFeb 2025authorised
MHRALicenseddate not shown
PMDAMar 2026approved
HCNov 2025approved
CDSCONot listed
EDENot listed
Approved or registered in 5 of 7 markets
Connections
About Eydenzelt
Eydenzelt is Celltrion's aflibercept, approved in Europe in February 2025, in the United States in October 2025 and in Canada a month later. In Japan it was approved in March 2026 as the fourth aflibercept biosimilar. It is Celltrion's first eye medicine.
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
Reference product in the Purple Book
Eylea
Marketing status (Purple Book)
Prescription, marketed
Presentations
2 mg/0.05 mL vial
Source
S001 (FDA); S016 (FDA Purple Book) · checked Sep 2026
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 (EMA) · checked Sep 2026
MHRA
United Kingdom · Eydenzelt
Medicines and Healthcare products Regulatory AgencyApprovedBrand
Eydenzelt
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 · Aflibercept BS CT
Pharmaceuticals and Medical Devices Agency and MHLWApprovedBrand
Aflibercept BS CT
Holder or applicant
Celltrion Healthcare Japan
Pathway
Biosimilar (MHLW approval on PMDA review)
Approved
Mar 2026
Indications as licensed
Wet AMD, RVO macular oedema, myopic CNV, DME
Presentations
40 mg/mL solution and kit
Remarks
Aflibercept Biosimilar 4.
Source
S020 (PMDA) · checked Sep 2026
HC
Canada · Eydenzelt
Health CanadaApprovedBrand
Eydenzelt
Holder or applicant
Celltrion INC.
Pathway
Biosimilar biologic drug (Notice of Compliance)
Approved
Nov 2025
Application or permission
DIN 02563037, 02563045
Presentations
2 mg
Source
S022 (Health Canada) · checked Sep 2026
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Other developers in the same markets
Where Eydenzelt holds an approval, these are the other aflibercept biosimilars approved in that market.
| Market | Rivals | Developers (product) |
|---|---|---|
| FDA | 5 | Amgen (Pavblu), Biocon Biologics (Yesafili), Formycon (Ahzantive / Baiama), Samsung Bioepis (Opuviz), Sandoz (Enzeevu / Afqlir) |
| EMA | 8 | Alteogen (Eyluxvi), Alvotech (Afiveg / Mynzepli), Amgen (Pavblu), Biocon Biologics (Yesafili), Formycon (Ahzantive / Baiama), Sam Chun Dang Pharm (Eiyzey / Vgenfli), Samsung Bioepis (Opuviz), Sandoz (Enzeevu / Afqlir) |
| MHRA | 7 | Alvotech (Afiveg / Mynzepli), Amgen (Pavblu), Biocon Biologics (Yesafili), Formycon (Ahzantive / Baiama), Sam Chun Dang Pharm (Eiyzey / Vgenfli), Samsung Bioepis (Opuviz), Sandoz (Enzeevu / Afqlir) |
| PMDA | 3 | Fuji Pharma (Aflibercept BS NIT), Global Regulatory Partners (Aflibercept BS GRP), Sam Chun Dang Pharm (Eiyzey / Vgenfli) |
| HC | 4 | Amgen (Pavblu), Apotex (Aflivu), Biocon Biologics (Yesafili), Sandoz (Enzeevu / Afqlir) |
Same developer, other molecules
Other biosimilars in the Atlas developed by Celltrion: Avtozma, Herzuma, Omlyclo, Remsima / Inflectra, Steqeyma, Stoboclo / Osenvelt, Truxima / Blitzima, Vegzelma, Yuflyma.
Chronology
- EMAFeb 2025Authorised by the European Commission as Eydenzelt
- FDAOct 2025Approved by FDA as Eydenzelt
- HCNov 2025Notice of Compliance, Health Canada as Eydenzelt
- PMDAMar 2026Approved by MHLW as Aflibercept BS CT
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)S020PMDA, list of approved biosimilar products in Japan (as of July 2026) 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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