Home/Biosimilar Atlas/Adalimumab/Hyrimoz / Hefiya

Hyrimoz / Hefiya

Adalimumab biosimilar developed by Sandoz, development code GP2017. Reference product Humira.

Brands by market: Hyrimoz (USA, EU, UAE); Hefiya (EU); Halimatoz (EU, withdrawn) · Commercial partner or holder: Sandoz · Company profile

FDAOct 2018approved

EMAJul 2018authorised

MHRALicenseddate not shown

PMDANot listed

HCNov 2020approved

CDSCONot listed

EDEOct 2019registered

Approved or registered in 5 of 7 markets

Connections

Adalimumabmolecule Sandozdeveloper 5 of 7markets 1trial behind it 9other products, same developer 10rival developers in its markets

About Hyrimoz / Hefiya

Hyrimoz is Sandoz's adalimumab, approved in Europe in 2018 and in the United States a few months later. In Europe it appears under three names: Hyrimoz, Hefiya and Halimatoz, of which Halimatoz was later withdrawn. It is interchangeable in the United States and registered in the UAE in both its original and high-concentration forms. Sandoz's presence in the Gulf comes through its partner Alphamed, and Hyrimoz is one of the longer-established adalimumab biosimilars there.

Status by market

FDA

United States · Hyrimoz

US Food and Drug AdministrationApproved

Brand

Hyrimoz

Holder or applicant

Sandoz Inc.

Pathway

351(k)

Approved

Oct 2018

Application or permission

761071

Licence type

351(k) interchangeable, designated Apr 2024

Reference product in the Purple Book

Humira

Marketing status (Purple Book)

Prescription; some presentations discontinued

First-interchangeable exclusivity expiry

Apr 2025

Presentations

10/0.1, 10/0.2, 20/0.2, 20/0.4, 40/0.4, 40/0.8, 80/0.8

Source

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

EMA

European Union · Hyrimoz

European Medicines Agency and European CommissionApproved

Brand

Hyrimoz

Holder or applicant

Sandoz GmbH

Pathway

Centralised (Article 10(4))

Approved

Jul 2018

Application or permission

EMEA/H/C/004320

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 · Hefiya

European Medicines Agency and European CommissionApproved

Brand

Hefiya

Holder or applicant

Sandoz GmbH

Pathway

Centralised (Article 10(4))

Approved

Jul 2018

Application or permission

EMEA/H/C/004865

Presentations

see SmPC

Remarks

Duplicate authorisation of Hyrimoz.

Source

S017 (EMA) · checked Sep 2026

EMA

European Union · Halimatoz

European Medicines Agency and European CommissionWithdrawn

Brand

Halimatoz

Holder or applicant

Sandoz GmbH

Pathway

Centralised (Article 10(4))

Approved

Jul 2018

Application or permission

EMEA/H/C/004866

Withdrawn

Dec 2020

Presentations

see SmPC

Remarks

Duplicate authorisation.

Source

S017 (EMA) · checked Sep 2026

MHRA

United Kingdom · Hyrimoz

Medicines and Healthcare products Regulatory AgencyApproved

Brand

Hyrimoz

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/0.4 mL and 80 mg/0.8 mL syringes and pens

Source

S023 (MHRA Products) · checked Sep 2026

PMDA

Japan

Not listed by PMDA.

Canada · Hyrimoz

Health CanadaApproved

Brand

Hyrimoz

Holder or applicant

Sandoz Canada Incorporated

Pathway

Biosimilar biologic drug (Notice of Compliance)

Approved

Nov 2020

Application or permission

DIN 02492156, 02492164, 02505258, 02542315, 02542323, 02542331, 02542358, 02542366

Presentations

20, 40, 80 mg

Source

S022 (Health Canada) · checked Sep 2026

CDSCO

India

Not listed by CDSCO.

EDE

United Arab Emirates · Hyrimoz

Emirates Drug EstablishmentRegistered

Brand

Hyrimoz

Holder or applicant

Novartis Pharmaceutical Manufacturing GmbH (Sandoz) · UAE supplier Alphamed Drug Store

Pathway

Registered medical product

Registered

Oct 2019

Presentations

40/0.8 (2019); 40/0.4 PFS and pen (2024)

Source

S018 (UAE Emirates Drug Establishment) · checked Sep 2026

Trials behind this product

Comparative trials on ClinicalTrials.gov matched to Hyrimoz / Hefiya 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
GP2017	Sandoz	Humira	Phase 3	Comparative efficacy	Completed	Dec 2013	Jul 2015	NCT02016105

Other developers in the same markets

Where Hyrimoz / Hefiya 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), Fujifilm Kyowa Kirin Biologics (Hulio), Pfizer (Abrilada / Amsparity), Samsung Bioepis (Hadlima / Imraldi)
EMA	7	Alvotech (Simlandi / Hukyndra / Libmyris), Amgen (Amjevita / Amgevita), Celltrion (Yuflyma), Fresenius Kabi (Idacio), Fujifilm Kyowa Kirin Biologics (Hulio), Pfizer (Abrilada / Amsparity), Samsung Bioepis (Hadlima / Imraldi)
MHRA	7	Alvotech (Simlandi / Hukyndra / Libmyris), Amgen (Amjevita / Amgevita), Celltrion (Yuflyma), Fresenius Kabi (Idacio), Fujifilm Kyowa Kirin Biologics (Hulio), Not stated in the MHRA list (Qletli), Samsung Bioepis (Hadlima / Imraldi)
HC	7	Alvotech (Simlandi / Hukyndra / Libmyris), Amgen (Amjevita / Amgevita), Celltrion (Yuflyma), Fresenius Kabi (Idacio), Fujifilm Kyowa Kirin Biologics (Hulio), Pfizer (Abrilada / Amsparity), Samsung Bioepis (Hadlima / Imraldi)
EDE	3	Amgen (Amjevita / Amgevita), Fresenius Kabi (Idacio), Fujifilm Kyowa Kirin Biologics (Hulio)

Same developer, other molecules

Other biosimilars in the Atlas developed by Sandoz: Binocrit / Epoetin alfa Hexal / Abseamed, Enzeevu / Afqlir, Erelzi, Inclunox, Jubbonti / Wyost, Omnitrope, Rixathon / Riximyo, Zarxio / Zarzio, Ziextenzo.

Chronology

EMAJul 2018Authorised by the European Commission as Hefiya
EMAJul 2018Authorised by the European Commission as Hyrimoz
FDAOct 2018Approved by FDA as Hyrimoz
EDEOct 2019Registered in the UAE as Hyrimoz
HCNov 2020Notice of Compliance, Health Canada as Hyrimoz
EMADec 2020Halimatoz authorisation withdrawn
FDAApr 2024Hyrimoz 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)
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

Planning adalimumab biosimilar development?

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Data current to September 2026.