Imuldosa
Ustekinumab biosimilar developed by Dong-A ST and Meiji Seika, development code DMB-3115. Reference product Stelara.
Brands by market: Imuldosa (USA, EU, UAE); Absimky (EU, withdrawn) · Commercial partner or holder: Accord BioPharma (USA); Accord Healthcare (EU, UAE) · Company profile
FDAOct 2024approved
EMADec 2024authorised
MHRALicenseddate not shown
PMDANot listed
HCNot listed
CDSCONot listed
EDEMay 2025registered
Approved or registered in 4 of 7 markets
Connections
About Imuldosa
Imuldosa is the ustekinumab developed by Dong-A ST of Korea with Meiji Seika of Japan, and sold by Accord in the United States, Europe and the UAE. It was approved in the United States in October 2024, in Europe in December, and registered in the UAE in 2025. It became interchangeable in the United States in 2026. A duplicate European name, Absimky, was withdrawn.
Status by market
FDA
United States · Imuldosa
US Food and Drug AdministrationApprovedBrand
Imuldosa
Holder or applicant
Accord BioPharma Inc.
Pathway
351(k)
Approved
Oct 2024
Application or permission
761364
Licence type
351(k) interchangeable, designated Jun 2026
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 · Imuldosa
European Medicines Agency and European CommissionApprovedBrand
Imuldosa
Holder or applicant
Accord Healthcare S.L.U.
Pathway
Centralised (Article 10(4))
Approved
Dec 2024
Application or permission
EMEA/H/C/006221
Presentations
see SmPC
Source
S017 (EMA) · checked Sep 2026
EMA
European Union · Absimky
European Medicines Agency and European CommissionWithdrawnBrand
Absimky
Holder or applicant
Accord Healthcare S.L.U.
Pathway
Centralised (Article 10(4))
Approved
Dec 2024
Application or permission
EMEA/H/C/006585
Withdrawn
Dec 2025
Presentations
see SmPC
Remarks
Duplicate authorisation.
Source
S017 (EMA) · checked Sep 2026
MHRA
United Kingdom · Imuldosa
Medicines and Healthcare products Regulatory AgencyApprovedBrand
Imuldosa
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; 130 mg vial
Source
S023 (MHRA Products) · checked Sep 2026
PMDA
Japan
Not listed by PMDA.
HC
Canada
Not listed by HC.
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates · Imuldosa
Emirates Drug EstablishmentRegisteredBrand
Imuldosa
Holder or applicant
Accord Healthcare Limited, United Kingdom · UAE supplier Ashro Drug Store LLC
Pathway
Registered medical product
Registered
May 2025
Presentations
45 mg/0.5 mL, 90 mg/mL; 130 mg/26 mL vial
Source
S018 (UAE Emirates Drug Establishment) · checked Sep 2026
Other developers in the same markets
Where Imuldosa 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), Celltrion (Steqeyma), Formycon (Otulfi / Fymskina), Samsung Bioepis (Pyzchiva) |
| EMA | 7 | Alvotech (Selarsdi / Uzpruvo / Usgena), Amgen (Wezlana / Wezenla), Biocon Biologics (Yesintek / Usrenty), Celltrion (Steqeyma), Formycon (Otulfi / Fymskina), Gedeon Richter (Usymro), Samsung Bioepis (Pyzchiva) |
| MHRA | 7 | Alvotech (Selarsdi / Uzpruvo / Usgena), Amgen (Wezlana / Wezenla), Biocon Biologics (Yesintek / Usrenty), Celltrion (Steqeyma), Formycon (Otulfi / Fymskina), Gedeon Richter (Usymro), Samsung Bioepis (Pyzchiva) |
| EDE | 1 | Amgen (Wezlana / Wezenla) |
Chronology
- FDAOct 2024Approved by FDA as Imuldosa
- EMADec 2024Authorised by the European Commission as Imuldosa
- EDEMay 2025Registered in the UAE as Imuldosa
- EMADec 2025Absimky authorisation withdrawn
- FDAJun 2026Imuldosa designated interchangeable
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)S018UAE Emirates Drug Establishment, registered medical product directory Primary (regulator)S023MHRA Products, substance lists of licensed medicines (products.mhra.gov.uk) Primary (regulator)
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