Usymro
Ustekinumab biosimilar developed by Gedeon Richter. Reference product Stelara.
Brands by market: Usymro (EU) · Commercial partner or holder: Gedeon Richter
FDAnot listed
EMAAug 2025authorised
CDSCOnot listed
EDEnot listed
Status by market
FDA
United States
Not listed by FDA.
EMA
European Union · Usymro
European Medicines Agency and European CommissionApprovedBrand
Usymro
Holder or applicant
Gedeon Richter Plc.
Pathway
Centralised (Article 10(4))
Approved
Aug 2025
Application or permission
EMEA/H/C/006467
Presentations
see SmPC
Source
S017
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- EMAAug 2025Authorised by the European Commission
Sources
S017EMA, medicines data table (medicines-output-medicines-report_en.xlsx) Primary (regulator)
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