Hulio
Adalimumab biosimilar developed by Fujifilm Kyowa Kirin Biologics, development code FKB327. Reference product Humira.
Brands by market: Hulio (USA, EU, UAE) · Commercial partner or holder: Biocon Biologics (formerly Mylan / Viatris)
FDAJul 2020approved
EMASep 2018authorised
CDSCOnot listed
EDEMay 2025registered
Status by market
FDA
United States · Hulio
US Food and Drug AdministrationApprovedBrand
Hulio
Holder or applicant
Biocon Biologics Inc.
Pathway
351(k)
Approved
Jul 2020
Application or permission
761154
Licence type
351(k) interchangeable, designated Feb 2025
Presentations
20/0.4, 40/0.8
Source
S001, S016
EMA
European Union · Hulio
European Medicines Agency and European CommissionApprovedBrand
Hulio
Holder or applicant
Biosimilar Collaborations Ireland Limited
Pathway
Centralised (Article 10(4))
Approved
Sep 2018
Application or permission
EMEA/H/C/004429
Indications as licensed
RA, JIA, axSpA, PsA, psoriasis, HS, Crohn's disease, UC, uveitis
Presentations
see SmPC
Source
S017
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates · Hulio
Emirates Drug EstablishmentRegisteredBrand
Hulio
Holder or applicant
Terumo Yamaguchi Corporation for Biocon Biologics · UAE supplier Alphamed Drug Store
Pathway
Registered medical product
Registered
May 2025
Presentations
20/0.4 PFS; 40/0.8 PFS and pen
Source
S018
Chronology
- EMASep 2018Authorised by the European Commission as Hulio
- FDAJul 2020Approved by FDA as Hulio
- FDAFeb 2025Hulio designated interchangeable
- EDEMay 2025Registered in the UAE as Hulio
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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