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Brands by market: Imuldosa (USA, EU, UAE); Absimky (EU, withdrawn) · Commercial partner or holder: Accord BioPharma (USA); Accord Healthcare (EU, UAE)
FDAOct 2024approved
EMADec 2024authorised
CDSCOnot listed
EDEMay 2025registered
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
Presentations
45/0.5, 90/1 SC; 130/26 IV
Source
S001, S016
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
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Withdrawn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
Note
Duplicate authorisation.
Source
S017
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
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- EMADec 2025Absimky authorisation withdrawn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)
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