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Brands by market: Steqeyma (USA, EU); Qoyvolma (EU, withdrawn) · Commercial partner or holder: Celltrion · Company profile
FDADec 2024approved
EMAAug 2024authorised
MHRALicenseddate not shown
PMDAMar 2025approved
HCJul 2024approved
CDSCONot listed
EDENot listed
Approved or registered in 5 of 7 markets
Connections
About Steqeyma
Steqeyma is Celltrion's ustekinumab, approved in Canada and Europe in mid-2024, in the United States in December 2024, and in Japan in 2025, where it was the third ustekinumab biosimilar. It is interchangeable in the United States. A duplicate European name, Qoyvolma, was approved in 2025 and withdrawn in 2026.
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
Reference product in the Purple Book
Stelara
Marketing status (Purple Book)
Prescription, marketed
Presentations
45/0.5, 90/1 SC; 130/26 IV
Source
S001 (FDA); S016 (FDA Purple Book) · checked Sep 2026
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) · checked Sep 2026
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Withdrawn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
Remarks
Duplicate authorisation.
Source
S017 (EMA) · checked Sep 2026
MHRA
United Kingdom · Steqeyma
Medicines and Healthcare products Regulatory AgencyApprovedBrand
Steqeyma
Holder or applicant
Not shown in the MHRA substance list
Pathway
UK marketing authorisation (Great Britain and, for EU-converted licences, Northern Ireland)
Approved
not published
Presentations
45 mg and 90 mg syringes and pens; 130 mg vial
Source
S023 (MHRA Products) · checked Sep 2026
PMDA
Japan · Ustekinumab BS CT
Pharmaceuticals and Medical Devices Agency and MHLWApprovedBrand
Ustekinumab BS CT
Holder or applicant
Celltrion Healthcare Japan
Pathway
Biosimilar (MHLW approval on PMDA review)
Approved
Mar 2025
Indications as licensed
Plaque psoriasis, psoriatic arthritis
Presentations
45 mg syringe; 130 mg IV vial (2026)
Remarks
Ustekinumab Biosimilar 3.
Source
S020 (PMDA) · checked Sep 2026
HC
Canada · Steqeyma
Health CanadaApprovedBrand
Steqeyma
Holder or applicant
Celltrion INC.
Pathway
Biosimilar biologic drug (Notice of Compliance)
Approved
Jul 2024
Application or permission
DIN 02550245, 02550253, 02550261
Presentations
45, 90 mg; 5 mg
Remarks
Also Steqeyma Iv.
Source
S022 (Health Canada) · checked Sep 2026
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Other developers in the same markets
Where Steqeyma 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), Bio-Thera Solutions (Starjemza), Biocon Biologics (Yesintek / Usrenty), Dong-A ST (Imuldosa), Formycon (Otulfi / Fymskina), Samsung Bioepis (Pyzchiva) |
| EMA | 7 | Alvotech (Selarsdi / Uzpruvo / Usgena), Amgen (Wezlana / Wezenla), Biocon Biologics (Yesintek / Usrenty), Dong-A ST (Imuldosa), Formycon (Otulfi / Fymskina), Gedeon Richter (Usymro), Samsung Bioepis (Pyzchiva) |
| MHRA | 7 | Alvotech (Selarsdi / Uzpruvo / Usgena), Amgen (Wezlana / Wezenla), Biocon Biologics (Yesintek / Usrenty), Dong-A ST (Imuldosa), Formycon (Otulfi / Fymskina), Gedeon Richter (Usymro), Samsung Bioepis (Pyzchiva) |
| PMDA | 3 | Fuji Pharma (Ustekinumab BS F), Nipro (Ustekinumab BS Nipro), Yoshindo (Ustekinumab BS YD) |
| HC | 5 | Alvotech (Selarsdi / Uzpruvo / Usgena), Amgen (Wezlana / Wezenla), Biocon Biologics (Yesintek / Usrenty), Formycon (Otulfi / Fymskina), Samsung Bioepis (Pyzchiva) |
Same developer, other molecules
Other biosimilars in the Atlas developed by Celltrion: Avtozma, Eydenzelt, Herzuma, Omlyclo, Remsima / Inflectra, Stoboclo / Osenvelt, Truxima / Blitzima, Vegzelma, Yuflyma.
Chronology
- HCJul 2024Notice of Compliance, Health Canada as Steqeyma
- EMAAug 2024Authorised by the European Commission as Steqeyma
- FDADec 2024Approved by FDA as Steqeyma
- PMDAMar 2025Approved by MHLW as Ustekinumab BS CT
- 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)S020PMDA, list of approved biosimilar products in Japan (as of July 2026) Primary (regulator)S022Health Canada, Drug Product Database data extract (active and inactive product files, biosimilar table) Primary (regulator)S023MHRA Products, substance lists of licensed medicines (products.mhra.gov.uk) Primary (regulator)
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