Steqeyma
Ustekinumab biosimilar developed by Celltrion, development code CT-P43. Reference product Stelara.
Brands by market: Steqeyma (USA, EU); Qoyvolma (EU, withdrawn) · Commercial partner or holder: Celltrion
FDADec 2024approved
EMAAug 2024authorised
CDSCOnot listed
EDEnot listed
Status by market
FDA
United States · Steqeyma
US Food and Drug AdministrationApprovedBrand
Steqeyma
Holder or applicant
CELLTRION, Inc.
Pathway
351(k)
Approved
Dec 2024
Application or permission
761338
Licence type
351(k) interchangeable, designated Apr 2025
Presentations
45/0.5, 90/1 SC; 130/26 IV
Source
S001, S016
EMA
European Union · Steqeyma
European Medicines Agency and European CommissionApprovedBrand
Steqeyma
Holder or applicant
Celltrion Healthcare Hungary Kft.
Pathway
Centralised (Article 10(4))
Approved
Aug 2024
Application or permission
EMEA/H/C/005918
Presentations
see SmPC
Source
S017
EMA
European Union · Qoyvolma
European Medicines Agency and European CommissionWithdrawnBrand
Qoyvolma
Holder or applicant
Celltrion Healthcare Hungary Kft.
Pathway
Centralised (Article 10(4))
Approved
Jun 2025
Application or permission
EMEA/H/C/006649
Withdrawn
Jun 2026
Presentations
see SmPC
Note
Duplicate authorisation.
Source
S017
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- EMAAug 2024Authorised by the European Commission as Steqeyma
- FDADec 2024Approved by FDA as Steqeyma
- FDAApr 2025Steqeyma designated interchangeable
- EMAJun 2026Qoyvolma authorisation withdrawn
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)
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