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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Brands by market: Idacio (USA, EU, UAE); Kromeya (EU, withdrawn) · Commercial partner or holder: Fresenius Kabi · Company profile

FDADec 2022approved

EMAApr 2019authorised

MHRALicenseddate not shown

PMDANot listed

HCOct 2020approved

CDSCONot listed

EDEMar 2024registered

Approved or registered in 5 of 7 markets

Connections

Adalimumabmolecule Fresenius Kabideveloper 5 of 7markets 0trials behind it 4other products, same developer 10rival developers in its markets

About Idacio

Idacio was originally developed by Merck KGaA and is now owned by Fresenius Kabi. It is approved in Europe, the United States and the UAE. In Europe, Fresenius also held a second name, Kromeya, which it withdrew. Idacio is one of the two US adalimumab biosimilars that are not interchangeable, and it is offered in the original concentration.

Status by market

FDA

United States · Idacio

US Food and Drug AdministrationApproved

Brand

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

Reference product in the Purple Book

Humira

Marketing status (Purple Book)

Prescription, marketed

Presentations

40/0.8

Source

S001 (FDA); S016 (FDA Purple Book) · checked Sep 2026

EMA

European Union · Idacio

European Medicines Agency and European CommissionApproved

Brand

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) · checked Sep 2026

EMA

European Union · Kromeya

European Medicines Agency and European CommissionWithdrawn

Brand

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Withdrawn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

Remarks

Duplicate authorisation; withdrawal date not published in the EMA table.

Source

S017 (EMA) · checked Sep 2026

MHRA

United Kingdom · Idacio

Medicines and Healthcare products Regulatory AgencyApproved

Brand

Idacio

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

40 mg pen and syringe; 40 mg/0.8 mL paediatric

Source

S023 (MHRA Products) · checked Sep 2026

PMDA

Japan

Not listed by PMDA.

Canada · Idacio

Health CanadaApproved

Brand

Idacio

Holder or applicant

Fresenius Kabi Canada LTD

Pathway

Biosimilar biologic drug (Notice of Compliance)

Approved

Oct 2020

Application or permission

DIN 02502666, 02502674, 02502682

Presentations

40 mg

Source

S022 (Health Canada) · checked Sep 2026

CDSCO

India

Not listed by CDSCO.

EDE

United Arab Emirates · Idacio

Emirates Drug EstablishmentRegistered

Brand

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 (UAE Emirates Drug Establishment) · checked Sep 2026

Other developers in the same markets

Where Idacio holds an approval, these are the other adalimumab biosimilars approved in that market.

Market	Rivals	Developers (product)
FDA	9	Alvotech (Simlandi / Hukyndra / Libmyris), Amgen (Amjevita / Amgevita), Boehringer Ingelheim (Cyltezo), Celltrion (Yuflyma), Coherus BioSciences (Yusimry), Fujifilm Kyowa Kirin Biologics (Hulio), Pfizer (Abrilada / Amsparity), Samsung Bioepis (Hadlima / Imraldi), Sandoz (Hyrimoz / Hefiya)
EMA	7	Alvotech (Simlandi / Hukyndra / Libmyris), Amgen (Amjevita / Amgevita), Celltrion (Yuflyma), Fujifilm Kyowa Kirin Biologics (Hulio), Pfizer (Abrilada / Amsparity), Samsung Bioepis (Hadlima / Imraldi), Sandoz (Hyrimoz / Hefiya)
MHRA	7	Alvotech (Simlandi / Hukyndra / Libmyris), Amgen (Amjevita / Amgevita), Celltrion (Yuflyma), Fujifilm Kyowa Kirin Biologics (Hulio), Not stated in the MHRA list (Qletli), Samsung Bioepis (Hadlima / Imraldi), Sandoz (Hyrimoz / Hefiya)
HC	7	Alvotech (Simlandi / Hukyndra / Libmyris), Amgen (Amjevita / Amgevita), Celltrion (Yuflyma), Fujifilm Kyowa Kirin Biologics (Hulio), Pfizer (Abrilada / Amsparity), Samsung Bioepis (Hadlima / Imraldi), Sandoz (Hyrimoz / Hefiya)
EDE	3	Amgen (Amjevita / Amgevita), Fujifilm Kyowa Kirin Biologics (Hulio), Sandoz (Hyrimoz / Hefiya)

Same developer, other molecules

Other biosimilars in the Atlas developed by Fresenius Kabi: Conexxence / Bomyntra, Elonox, Stimufend, Tyenne.

Chronology

EMAApr 2019Authorised by the European Commission as Idacio
HCOct 2020Notice of Compliance, Health Canada 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)
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)

All adalimumab biosimilars

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Data current to September 2026.