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Brands by market: Hyrimoz (USA, EU, UAE); Hefiya (EU); Halimatoz (EU, withdrawn) · Commercial partner or holder: Sandoz
FDAOct 2018approved
EMAJul 2018authorised
CDSCOnot listed
EDEOct 2019registered
Status by market
FDA
United States · Hyrimoz
US Food and Drug AdministrationApprovedBrand
Hyrimoz
Holder or applicant
Sandoz Inc.
Pathway
351(k)
Approved
Oct 2018
Application or permission
761071
Licence type
351(k) interchangeable, designated Apr 2024
Presentations
10/0.1, 10/0.2, 20/0.2, 20/0.4, 40/0.4, 40/0.8, 80/0.8
Source
S001, S016
EMA
European Union · Hyrimoz
European Medicines Agency and European CommissionApprovedBrand
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
European Union · Hefiya
European Medicines Agency and European CommissionApprovedBrand
Hefiya
Holder or applicant
Sandoz GmbH
Pathway
Centralised (Article 10(4))
Approved
Jul 2018
Application or permission
EMEA/H/C/004865
Presentations
see SmPC
Note
Duplicate authorisation of Hyrimoz.
Source
S017
EMA
European Union · Halimatoz
European Medicines Agency and European CommissionWithdrawnBrand
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Withdrawn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
Note
Duplicate authorisation.
Source
S017
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates · Hyrimoz
Emirates Drug EstablishmentRegisteredBrand
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
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
- EMADec 2020Halimatoz authorisation withdrawn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)
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