Otulfi / Fymskina
Ustekinumab biosimilar developed by Formycon, development code FYB202. Reference product Stelara.
Brands by market: Otulfi (USA, EU); Fymskina (EU) · Commercial partner or holder: Fresenius Kabi
FDASep 2024approved
EMASep 2024authorised
CDSCOnot listed
EDEnot listed
Status by market
FDA
United States · Otulfi
US Food and Drug AdministrationApprovedBrand
Otulfi
Holder or applicant
Fresenius Kabi USA, LLC
Pathway
351(k)
Approved
Sep 2024
Application or permission
761379
Licence type
351(k) interchangeable, designated Apr 2025
Presentations
45/0.5, 90/1 SC; 130/26 IV
Source
S001, S016
EMA
European Union · Otulfi
European Medicines Agency and European CommissionApprovedBrand
Otulfi
Holder or applicant
Fresenius Kabi Deutschland GmbH
Pathway
Centralised (Article 10(4))
Approved
Sep 2024
Application or permission
EMEA/H/C/006544
Presentations
see SmPC
Source
S017
EMA
European Union · Fymskina
European Medicines Agency and European CommissionApprovedBrand
Fymskina
Holder or applicant
Formycon AG
Pathway
Centralised (Article 10(4))
Approved
Sep 2024
Application or permission
EMEA/H/C/005805
Presentations
see SmPC
Source
S017
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- EMASep 2024Authorised by the European Commission as Fymskina
- EMASep 2024Authorised by the European Commission as Otulfi
- FDASep 2024Approved by FDA as Otulfi
- FDAApr 2025Otulfi designated interchangeable
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 ustekinumab 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.