Starjemza
Ustekinumab biosimilar developed by Bio-Thera Solutions, development code BAT2206. Reference product Stelara.
About Starjemza
Starjemza is the ustekinumab developed by Bio-Thera Solutions of China and sold by Hikma in the United States, approved in May 2025 and interchangeable from the start. It was the eighth and most recent ustekinumab biosimilar in the United States and has not been filed in Europe.
Status by market
United States · Starjemza
US Food and Drug AdministrationApprovedEuropean Union
Not listed by EMA.
United Kingdom
Not listed by MHRA.
Japan
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 Starjemza holds an approval, these are the other ustekinumab biosimilars approved in that market.
| Market | Rivals | Developers (product) |
|---|---|---|
| FDA | 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 Bio-Thera Solutions: Avzivi, Tofidence / Tocilizumab STADA.
Chronology
- FDAMay 2025Approved by FDA
Sources
S001FDA, Biosimilar Product Information (approved biosimilars table) Primary (regulator)S016FDA Purple Book, monthly data downloads January to August 2026 Primary (regulator)
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