Home/Biosimilar Atlas/Aflibercept/Enzeevu / Afqlir

Enzeevu / Afqlir

Aflibercept biosimilar developed by Sandoz. Reference product Eylea.

Brands by market: Enzeevu (USA); Afqlir (EU) · Commercial partner or holder: Sandoz · Company profile
FDAAug 2024approved
EMANov 2024authorised
MHRALicenseddate not shown
PMDANot listed
HCOct 2025approved
CDSCONot listed
EDENot listed
Approved or registered in 4 of 7 markets
Connections
AfliberceptmoleculeSandozdeveloper4 of 7markets0trials behind it9other products, same developer9rival developers in its markets

About Enzeevu / Afqlir

Sandoz's aflibercept is Enzeevu in the United States, approved in August 2024, and Afqlir in Europe, approved in November 2024. Canada approved Enzeevu in 2025. It gives Sandoz an eye medicine alongside its ranibizumab, Cimerli, which it sells in the United States for Formycon.

Status by market

FDA

United States · Enzeevu

US Food and Drug AdministrationApproved
Brand
Enzeevu
Holder or applicant
Sandoz Inc.
Pathway
351(k)
Approved
Aug 2024
Application or permission
761382
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 · Afqlir

European Medicines Agency and European CommissionApproved
Brand
Afqlir
Holder or applicant
Sandoz GmbH
Pathway
Centralised (Article 10(4))
Approved
Nov 2024
Application or permission
EMEA/H/C/006150
Presentations
see SmPC
Source
S017 (EMA) · checked Sep 2026
MHRA

United Kingdom · Afqlir

Medicines and Healthcare products Regulatory AgencyApproved
Brand
Afqlir
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 · Enzeevu

Health CanadaApproved
Brand
Enzeevu
Holder or applicant
Sandoz Canada Incorporated
Pathway
Biosimilar biologic drug (Notice of Compliance)
Approved
Oct 2025
Application or permission
DIN 02562510
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 Enzeevu / Afqlir holds an approval, these are the other aflibercept biosimilars approved in that market.

MarketRivalsDevelopers (product)
FDA5Amgen (Pavblu), Biocon Biologics (Yesafili), Celltrion (Eydenzelt), Formycon (Ahzantive / Baiama), Samsung Bioepis (Opuviz)
EMA8Alteogen (Eyluxvi), Alvotech (Afiveg / Mynzepli), Amgen (Pavblu), Biocon Biologics (Yesafili), Celltrion (Eydenzelt), Formycon (Ahzantive / Baiama), Sam Chun Dang Pharm (Eiyzey / Vgenfli), Samsung Bioepis (Opuviz)
MHRA7Alvotech (Afiveg / Mynzepli), Amgen (Pavblu), Biocon Biologics (Yesafili), Celltrion (Eydenzelt), Formycon (Ahzantive / Baiama), Sam Chun Dang Pharm (Eiyzey / Vgenfli), Samsung Bioepis (Opuviz)
HC4Amgen (Pavblu), Apotex (Aflivu), Biocon Biologics (Yesafili), Celltrion (Eydenzelt)

Same developer, other molecules

Other biosimilars in the Atlas developed by Sandoz: Binocrit / Epoetin alfa Hexal / Abseamed, Erelzi, Hyrimoz / Hefiya, Inclunox, Jubbonti / Wyost, Omnitrope, Rixathon / Riximyo, Zarxio / Zarzio, Ziextenzo.

Chronology

Sources

All aflibercept biosimilars

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Data current to September 2026.