Home/Biosimilar Atlas/Aflibercept/Opuviz

Opuviz

Aflibercept biosimilar developed by Samsung Bioepis, development code SB15. Reference product Eylea.

Brands by market: Opuviz (USA, EU) · Commercial partner or holder: Biogen (USA, EU) · Company profile
FDAMay 2024approved
EMANov 2024authorised
MHRALicenseddate not shown
PMDANot listed
HCNot listed
CDSCONot listed
EDENot listed
Approved or registered in 3 of 7 markets
Connections
AfliberceptmoleculeSamsung Bioepisdeveloper3 of 7markets1trial behind it9other products, same developer8rival developers in its markets

About Opuviz

Opuviz is Samsung Bioepis's aflibercept, sold by Biogen and approved in the United States in May 2024 on the same day as Yesafili, also interchangeable from the start. Europe approved it in November 2024. It follows Byooviz, the same partners' ranibizumab.

Status by market

FDA

United States · Opuviz

US Food and Drug AdministrationApproved
Brand
Opuviz
Holder or applicant
Samsung Bioepis Co., Ltd.
Pathway
351(k)
Approved
May 2024
Application or permission
761350
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
Source
S001 (FDA); S016 (FDA Purple Book) · checked Sep 2026
EMA

European Union · Opuviz

European Medicines Agency and European CommissionApproved
Brand
Opuviz
Holder or applicant
Samsung Bioepis NL B.V.
Pathway
Centralised (Article 10(4))
Approved
Nov 2024
Application or permission
EMEA/H/C/006056
Presentations
see SmPC
Source
S017 (EMA) · checked Sep 2026
MHRA

United Kingdom · Opuviz

Medicines and Healthcare products Regulatory AgencyApproved
Brand
Opuviz
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

Not listed by HC.

CDSCO

India

Not listed by CDSCO.

EDE

United Arab Emirates

Not listed by EDE.

Trials behind this product

Comparative trials on ClinicalTrials.gov matched to Opuviz by development code, brand or developer. Registry data, sponsor-entered.

CandidateDeveloper or sponsorReference productPhaseDesignRegistry statusStartedPrimary completionRegistry record
SB15Samsung BioepisEyleaPhase 3Comparative efficacyCompletedJun 2020Apr 2021NCT04450329

Other developers in the same markets

Where Opuviz 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), Sandoz (Enzeevu / Afqlir)
EMA8Alteogen (Eyluxvi), Alvotech (Afiveg / Mynzepli), Amgen (Pavblu), Biocon Biologics (Yesafili), Celltrion (Eydenzelt), Formycon (Ahzantive / Baiama), Sam Chun Dang Pharm (Eiyzey / Vgenfli), Sandoz (Enzeevu / Afqlir)
MHRA7Alvotech (Afiveg / Mynzepli), Amgen (Pavblu), Biocon Biologics (Yesafili), Celltrion (Eydenzelt), Formycon (Ahzantive / Baiama), Sam Chun Dang Pharm (Eiyzey / Vgenfli), Sandoz (Enzeevu / Afqlir)

Same developer, other molecules

Other biosimilars in the Atlas developed by Samsung Bioepis: Aybintio, Byooviz, Epysqli, Eticovo / Benepali, Hadlima / Imraldi, Ontruzant, Ospomyv / Xbryk / Obodence, Pyzchiva, Renflexis / Flixabi.

Chronology

Sources

All aflibercept biosimilars

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Data current to September 2026.