Selarsdi / Uzpruvo / Usgena
Ustekinumab biosimilar developed by Alvotech, development code AVT04. Reference product Stelara.
About Selarsdi / Uzpruvo / Usgena
Alvotech's ustekinumab was the first approved in Europe, as Uzpruvo through Stada, in January 2024. In the United States it is sold by Teva as Selarsdi, approved in 2024 and interchangeable since 2025. Canada approved it first of all, as Jamteki through JAMP, in late 2023, and Stada later added a second European name, Usgena.
Status by market
United States · Selarsdi
US Food and Drug AdministrationApprovedEuropean Union · Uzpruvo
European Medicines Agency and European CommissionApprovedEuropean Union · Usgena
European Medicines Agency and European CommissionApprovedUnited Kingdom · Uzpruvo
Medicines and Healthcare products Regulatory AgencyApprovedJapan
Not listed by PMDA.
Canada · Jamteki
Health CanadaApprovedIndia
Not listed by CDSCO.
United Arab Emirates
Not listed by EDE.
Trials behind this product
Comparative trials on ClinicalTrials.gov matched to Selarsdi / Uzpruvo / Usgena by development code, brand or developer. Registry data, sponsor-entered.
| Candidate | Developer or sponsor | Reference product | Phase | Design | Registry status | Started | Primary completion | Registry record |
|---|---|---|---|---|---|---|---|---|
| AVT04 | Alvotech | Stelara | Phase 3 | Comparative efficacy | Completed | Jun 2021 | Dec 2021 | NCT04930042 |
| AVT04 | Alvotech | Stelara | Phase 1 | Comparative PK | Completed | May 2021 | Mar 2022 | NCT04744363 |
Other developers in the same markets
Where Selarsdi / Uzpruvo / Usgena holds an approval, these are the other ustekinumab biosimilars approved in that market.
| Market | Rivals | Developers (product) |
|---|---|---|
| FDA | 7 | Amgen (Wezlana / Wezenla), Bio-Thera Solutions (Starjemza), Biocon Biologics (Yesintek / Usrenty), Celltrion (Steqeyma), Dong-A ST (Imuldosa), Formycon (Otulfi / Fymskina), Samsung Bioepis (Pyzchiva) |
| EMA | 7 | Amgen (Wezlana / Wezenla), Biocon Biologics (Yesintek / Usrenty), Celltrion (Steqeyma), Dong-A ST (Imuldosa), Formycon (Otulfi / Fymskina), Gedeon Richter (Usymro), Samsung Bioepis (Pyzchiva) |
| MHRA | 7 | Amgen (Wezlana / Wezenla), Biocon Biologics (Yesintek / Usrenty), Celltrion (Steqeyma), Dong-A ST (Imuldosa), Formycon (Otulfi / Fymskina), Gedeon Richter (Usymro), Samsung Bioepis (Pyzchiva) |
| HC | 5 | Amgen (Wezlana / Wezenla), Biocon Biologics (Yesintek / Usrenty), Celltrion (Steqeyma), Formycon (Otulfi / Fymskina), Samsung Bioepis (Pyzchiva) |
Same developer, other molecules
Other biosimilars in the Atlas developed by Alvotech: Afiveg / Mynzepli, Gobivaz / Gotenfia, Simlandi / Hukyndra / Libmyris, Zvogra / Kefdensis / Xbonzy / Acvybra.
Chronology
- HCNov 2023Notice of Compliance, Health Canada as Jamteki
- 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)S022Health Canada, Drug Product Database data extract (active and inactive product files, biosimilar table) Primary (regulator)S023MHRA Products, substance lists of licensed medicines (products.mhra.gov.uk) Primary (regulator)
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