Starjemza
Ustekinumab biosimilar developed by Bio-Thera Solutions, development code BAT2206. Reference product Stelara.
Brands by market: Starjemza (USA) · Commercial partner or holder: Hikma (USA)
FDAMay 2025approved
EMAnot listed
CDSCOnot listed
EDEnot listed
Status by market
FDA
United States · Starjemza
US Food and Drug AdministrationApprovedBrand
Starjemza
Holder or applicant
Bio-Thera Solutions, Ltd.
Pathway
351(k)
Approved
May 2025
Application or permission
761419
Licence type
351(k) interchangeable, designated May 2025
Presentations
45/0.5, 90/1 SC; 130/26 IV
Source
S001, S016
EMA
European Union
Not listed by EMA.
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
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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