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)
FDAJun 2024approved
EMAJan 2025authorised
CDSCOnot listed
EDEnot listed
Status by market
FDA
United States · Ahzantive
US Food and Drug AdministrationApprovedBrand
Ahzantive
Holder or applicant
Formycon AG
Pathway
351(k)
Approved
Jun 2024
Application or permission
761378
Licence type
351(k) biosimilar, not interchangeable
Presentations
2 mg/0.05 mL vial
Source
S001, S016
EMA
European Union · Ahzantive
European Medicines Agency and European CommissionApprovedBrand
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
European Union · Baiama
European Medicines Agency and European CommissionApprovedBrand
Baiama
Holder or applicant
Formycon AG
Pathway
Centralised (Article 10(4))
Approved
Jan 2025
Application or permission
EMEA/H/C/005980
Presentations
see SmPC
Note
Second Formycon brand.
Source
S017
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- FDAJun 2024Approved by FDA as Ahzantive
- EMAJan 2025Authorised by the European Commission as Ahzantive
- EMAJan 2025Authorised by the European Commission as Baiama
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)
Planning aflibercept biosimilar development?
EvySaif can help assess your regulatory pathway, clinical evidence requirements and market-entry strategy across India, UAE and other target markets.
Talk to a biosimilar regulatory consultantData current to September 2026.