Selarsdi / Uzpruvo / Usgena
Ustekinumab biosimilar developed by Alvotech, development code AVT04. Reference product Stelara.
Brands by market: Selarsdi (USA); Uzpruvo and Usgena (EU) · Commercial partner or holder: Teva (USA); Stada (EU)
FDAApr 2024approved
EMAJan 2024authorised
CDSCOnot listed
EDEnot listed
Status by market
FDA
United States · Selarsdi
US Food and Drug AdministrationApprovedBrand
Selarsdi
Holder or applicant
Alvotech USA Inc.
Pathway
351(k)
Approved
Apr 2024
Application or permission
761343
Licence type
351(k) interchangeable, designated Apr 2025
Presentations
45/0.5, 90/1 SC; 130/26 IV
Source
S001, S016
EMA
European Union · Uzpruvo
European Medicines Agency and European CommissionApprovedBrand
Uzpruvo
Holder or applicant
Stada Arzneimittel AG
Pathway
Centralised (Article 10(4))
Approved
Jan 2024
Application or permission
EMEA/H/C/006101
Indications as licensed
Psoriasis, psoriatic arthritis, Crohn's disease, UC
Presentations
see SmPC
Note
First EU ustekinumab biosimilar.
Source
S017
EMA
European Union · Usgena
European Medicines Agency and European CommissionApprovedBrand
Usgena
Holder or applicant
Stada Arzneimittel AG
Pathway
Centralised (Article 10(4))
Approved
Nov 2025
Application or permission
EMEA/H/C/006667
Presentations
see SmPC
Note
Second Stada brand.
Source
S017
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- EMAJan 2024Authorised by the European Commission as Uzpruvo
- FDAApr 2024Approved by FDA as Selarsdi
- FDAApr 2025Selarsdi designated interchangeable
- EMANov 2025Authorised by the European Commission as Usgena
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)
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