Idacio
Adalimumab biosimilar developed by Fresenius Kabi (originally Merck KGaA), development code MSB11022. Reference product Humira.
Brands by market: Idacio (USA, EU, UAE); Kromeya (EU, withdrawn) · Commercial partner or holder: Fresenius Kabi
FDADec 2022approved
EMAApr 2019authorised
CDSCOnot listed
EDEMar 2024registered
Status by market
FDA
United States · Idacio
US Food and Drug AdministrationApprovedBrand
Idacio
Holder or applicant
Fresenius Kabi USA, LLC
Pathway
351(k)
Approved
Dec 2022
Application or permission
761255
Licence type
351(k) biosimilar, not interchangeable
Presentations
40/0.8
Source
S001, S016
EMA
European Union · Idacio
European Medicines Agency and European CommissionApprovedBrand
Idacio
Holder or applicant
Fresenius Kabi Deutschland GmbH
Pathway
Centralised (Article 10(4))
Approved
Apr 2019
Application or permission
EMEA/H/C/004475
Indications as licensed
RA, JIA, axSpA, PsA, psoriasis, HS, Crohn's disease, UC, uveitis
Presentations
see SmPC
Source
S017
EMA
European Union · Kromeya
European Medicines Agency and European CommissionWithdrawnBrand
Kromeya
Holder or applicant
Fresenius Kabi Deutschland GmbH
Pathway
Centralised (Article 10(4))
Approved
Apr 2019
Application or permission
EMEA/H/C/005158
Withdrawn
date not published
Presentations
see SmPC
Note
Duplicate authorisation; withdrawal date not published in the EMA table.
Source
S017
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates · Idacio
Emirates Drug EstablishmentRegisteredBrand
Idacio
Holder or applicant
Fresenius Kabi Austria GmbH · UAE supplier Gulf Drug LLC
Pathway
Registered medical product
Registered
Mar 2024
Presentations
40 mg pen and syringe
Source
S018
Chronology
- EMAApr 2019Authorised by the European Commission as Idacio
- FDADec 2022Approved by FDA as Idacio
- EDEMar 2024Registered in the UAE as Idacio
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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