Usymro
Ustekinumab biosimilar developed by Gedeon Richter. Reference product Stelara.
About Usymro
Usymro is Gedeon Richter's ustekinumab, approved in Europe in August 2025. Richter has not named the developer of the product. It joined Richter's growing biosimilar range, which also includes denosumab, teriparatide and tocilizumab.
Status by market
United States
Not listed by FDA.
European Union · Usymro
European Medicines Agency and European CommissionApprovedUnited Kingdom · Usymro
Medicines and Healthcare products Regulatory AgencyApprovedJapan
Not listed by PMDA.
Canada
Not listed by HC.
India
Not listed by CDSCO.
United Arab Emirates
Not listed by EDE.
Other developers in the same markets
Where Usymro holds an approval, these are the other ustekinumab biosimilars approved in that market.
| Market | Rivals | Developers (product) |
|---|---|---|
| EMA | 7 | Alvotech (Selarsdi / Uzpruvo / Usgena), Amgen (Wezlana / Wezenla), Biocon Biologics (Yesintek / Usrenty), Celltrion (Steqeyma), Dong-A ST (Imuldosa), Formycon (Otulfi / Fymskina), Samsung Bioepis (Pyzchiva) |
| MHRA | 7 | Alvotech (Selarsdi / Uzpruvo / Usgena), Amgen (Wezlana / Wezenla), Biocon Biologics (Yesintek / Usrenty), Celltrion (Steqeyma), Dong-A ST (Imuldosa), Formycon (Otulfi / Fymskina), Samsung Bioepis (Pyzchiva) |
Same developer, other molecules
Other biosimilars in the Atlas developed by Gedeon Richter: Enoby / Xtrenbo / Junod / Yaxwer, Terrosa / Movymia, Tuyory.
Chronology
- EMAAug 2025Authorised by the European Commission as Usymro
Sources
S017EMA, medicines data table (medicines-output-medicines-report_en.xlsx) Primary (regulator)S023MHRA Products, substance lists of licensed medicines (products.mhra.gov.uk) Primary (regulator)
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