Home/Biosimilar Atlas/Aflibercept/Ahzantive / Baiama

Ahzantive / Baiama

Aflibercept biosimilar developed by Formycon, development code FYB203. Reference product Eylea.

Brands by market: Ahzantive (USA, EU); Baiama (EU) · Commercial partner or holder: Valorum (USA); Formycon and partners (EU) · Company profile
FDAJun 2024approved
EMAJan 2025authorised
MHRALicenseddate not shown
PMDANot listed
HCNot listed
CDSCONot listed
EDENot listed
Approved or registered in 3 of 7 markets
Connections
AfliberceptmoleculeFormycondeveloper3 of 7markets1trial behind it1other products, same developer8rival developers in its markets

About Ahzantive / Baiama

Ahzantive is Formycon's aflibercept, approved in the United States in June 2024 and in Europe in January 2025, where Formycon also holds a second name, Baiama. In the United States it is sold by Valorum. Formycon, a German developer, also made the ranibizumab sold as Cimerli and the ustekinumab sold as Otulfi.

Status by market

FDA

United States · Ahzantive

US Food and Drug AdministrationApproved
Brand
Ahzantive
Holder or applicant
Formycon AG
Pathway
351(k)
Approved
Jun 2024
Application or permission
761378
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 · Ahzantive

European Medicines Agency and European CommissionApproved
Brand
Ahzantive
Holder or applicant
Formycon AG
Pathway
Centralised (Article 10(4))
Approved
Jan 2025
Application or permission
EMEA/H/C/006607
Presentations
see SmPC
Source
S017 (EMA) · checked Sep 2026
EMA

European Union · Baiama

European Medicines Agency and European CommissionApproved
Brand
Baiama
Holder or applicant
Formycon AG
Pathway
Centralised (Article 10(4))
Approved
Jan 2025
Application or permission
EMEA/H/C/005980
Presentations
see SmPC
Remarks
Second Formycon brand.
Source
S017 (EMA) · checked Sep 2026
MHRA

United Kingdom · Ahzantive

Medicines and Healthcare products Regulatory AgencyApproved
Brand
Ahzantive
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 Ahzantive / Baiama by development code, brand or developer. Registry data, sponsor-entered.

CandidateDeveloper or sponsorReference productPhaseDesignRegistry statusStartedPrimary completionRegistry record
FYB203BioeqEyleaPhase 3Comparative efficacyCompletedJul 2020Jun 2022NCT04522167

Other developers in the same markets

Where Ahzantive / Baiama holds an approval, these are the other aflibercept biosimilars approved in that market.

MarketRivalsDevelopers (product)
FDA5Amgen (Pavblu), Biocon Biologics (Yesafili), Celltrion (Eydenzelt), Samsung Bioepis (Opuviz), Sandoz (Enzeevu / Afqlir)
EMA8Alteogen (Eyluxvi), Alvotech (Afiveg / Mynzepli), Amgen (Pavblu), Biocon Biologics (Yesafili), Celltrion (Eydenzelt), Sam Chun Dang Pharm (Eiyzey / Vgenfli), Samsung Bioepis (Opuviz), Sandoz (Enzeevu / Afqlir)
MHRA7Alvotech (Afiveg / Mynzepli), Amgen (Pavblu), Biocon Biologics (Yesafili), Celltrion (Eydenzelt), Sam Chun Dang Pharm (Eiyzey / Vgenfli), Samsung Bioepis (Opuviz), Sandoz (Enzeevu / Afqlir)

Same developer, other molecules

Other biosimilars in the Atlas developed by Formycon: Otulfi / Fymskina.

Chronology

Sources

All aflibercept biosimilars

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Data current to September 2026.