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) · Company profile

FDAJul 2020approved

EMASep 2018authorised

MHRALicenseddate not shown

PMDAJun 2020approved

HCNov 2020approved

CDSCONot listed

EDEMay 2025registered

Approved or registered in 6 of 7 markets

Connections

Adalimumabmolecule Fujifilm Kyowa Kirin Biologicsdeveloper 6 of 7markets 3trials behind it 0other products, same developer 12rival developers in its markets

About Hulio

Hulio was developed by Fujifilm Kyowa Kirin Biologics in Japan and is marketed by Biocon Biologics, which took it over from Mylan. It is approved in Europe, the United States, Japan and the UAE, one of the few adalimumab biosimilars registered in all four. In Japan it was the first adalimumab biosimilar, approved in 2020. It is interchangeable in the United States and is available in the original concentration.

Status by market

FDA

United States · Hulio

US Food and Drug AdministrationApproved

Brand

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

Reference product in the Purple Book

Humira

Marketing status (Purple Book)

Prescription, marketed

Presentations

20/0.4, 40/0.8

Source

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

EMA

European Union · Hulio

European Medicines Agency and European CommissionApproved

Brand

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 (EMA) · checked Sep 2026

MHRA

United Kingdom · Hulio

Medicines and Healthcare products Regulatory AgencyApproved

Brand

Hulio

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

20 mg and 40 mg syringes; 40 mg pen; 40 mg/0.8 mL vial

Source

S023 (MHRA Products) · checked Sep 2026

PMDA

Japan · Adalimumab BS FKB

Pharmaceuticals and Medical Devices Agency and MHLWApproved

Brand

Adalimumab BS FKB

Holder or applicant

Fujifilm Kyowa Kirin Biologics

Pathway

Biosimilar (MHLW approval on PMDA review)

Approved

Jun 2020

Indications as licensed

RA, pJIA, psoriasis, PsA, pustular psoriasis, AS, intestinal Behcet’s, Crohn’s disease

Presentations

20 mg/0.4 mL and 40 mg/0.8 mL syringes; 40 mg/0.8 mL pen

Remarks

Adalimumab Biosimilar 1, the first in Japan.

Source

S020 (PMDA) · checked Sep 2026

Canada · Hulio

Health CanadaApproved

Brand

Hulio

Holder or applicant

Biocon Biologics Canada INC

Pathway

Biosimilar biologic drug (Notice of Compliance)

Approved

Nov 2020

Application or permission

DIN 02502380, 02502399, 02502402

Presentations

20, 40 mg

Source

S022 (Health Canada) · checked Sep 2026

CDSCO

India

Not listed by CDSCO.

EDE

United Arab Emirates · Hulio

Emirates Drug EstablishmentRegistered

Brand

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 (UAE Emirates Drug Establishment) · checked Sep 2026

Trials behind this product

Comparative trials on ClinicalTrials.gov matched to Hulio by development code, brand or developer. Registry data, sponsor-entered.

Candidate	Developer or sponsor	Reference product	Phase	Design	Registry status	Started	Primary completion	Registry record
Hulio	Biocon Biologics	Humira	Phase 3	Switching	Completed	Nov 2022	Sep 2023	NCT05637515
FKB327	Fujifilm Kyowa Kirin Biologics	Humira	Phase 3	Comparative efficacy	Completed	Jun 2015	Jan 2018	NCT02405780
MYL-1401A	Viatris	Humira	Phase 3	Comparative efficacy	Completed	Jun 2015	May 2016	NCT02714322

Other developers in the same markets

Where Hulio 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), Fresenius Kabi (Idacio), Pfizer (Abrilada / Amsparity), Samsung Bioepis (Hadlima / Imraldi), Sandoz (Hyrimoz / Hefiya)
EMA	7	Alvotech (Simlandi / Hukyndra / Libmyris), Amgen (Amjevita / Amgevita), Celltrion (Yuflyma), Fresenius Kabi (Idacio), Pfizer (Abrilada / Amsparity), Samsung Bioepis (Hadlima / Imraldi), Sandoz (Hyrimoz / Hefiya)
MHRA	7	Alvotech (Simlandi / Hukyndra / Libmyris), Amgen (Amjevita / Amgevita), Celltrion (Yuflyma), Fresenius Kabi (Idacio), Not stated in the MHRA list (Qletli), Samsung Bioepis (Hadlima / Imraldi), Sandoz (Hyrimoz / Hefiya)
PMDA	3	Celltrion (Yuflyma), Daiichi Sankyo (Adalimumab BS Daiichi Sankyo), Mochida Pharmaceutical (Adalimumab BS MA)
HC	7	Alvotech (Simlandi / Hukyndra / Libmyris), Amgen (Amjevita / Amgevita), Celltrion (Yuflyma), Fresenius Kabi (Idacio), Pfizer (Abrilada / Amsparity), Samsung Bioepis (Hadlima / Imraldi), Sandoz (Hyrimoz / Hefiya)
EDE	3	Amgen (Amjevita / Amgevita), Fresenius Kabi (Idacio), Sandoz (Hyrimoz / Hefiya)

Chronology

EMASep 2018Authorised by the European Commission as Hulio
PMDAJun 2020Approved by MHLW as Adalimumab BS FKB
FDAJul 2020Approved by FDA as Hulio
HCNov 2020Notice of Compliance, Health Canada 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)
S020PMDA, list of approved biosimilar products in Japan (as of July 2026) 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.