Hadlima / Imraldi
Adalimumab biosimilar developed by Samsung Bioepis, development code SB5. Reference product Humira.
Brands by market: Hadlima (USA); Imraldi (EU) · Commercial partner or holder: Organon (USA); Biogen (EU)
FDAJul 2019approved
EMAAug 2017authorised
CDSCOnot listed
EDEnot listed
Status by market
FDA
United States · Hadlima
US Food and Drug AdministrationApprovedBrand
Hadlima
Holder or applicant
Samsung Bioepis Co., Ltd.
Pathway
351(k)
Approved
Jul 2019
Application or permission
761059
Licence type
351(k) interchangeable, designated Jun 2024
Presentations
40/0.4, 40/0.8, 80/0.8
Source
S001, S016
EMA
European Union · Imraldi
European Medicines Agency and European CommissionApprovedBrand
Imraldi
Holder or applicant
Samsung Bioepis NL B.V.
Pathway
Centralised (Article 10(4))
Approved
Aug 2017
Application or permission
EMEA/H/C/004279
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
Not listed by EDE.
Chronology
- EMAAug 2017Authorised by the European Commission as Imraldi
- FDAJul 2019Approved by FDA as Hadlima
- FDAJun 2024Hadlima 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)
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