Amjevita / Amgevita
Adalimumab biosimilar developed by Amgen, development code ABP 501. Reference product Humira.
Brands by market: Amjevita (USA); Amgevita (EU, UAE); Solymbic (EU, withdrawn) · Commercial partner or holder: Amgen
FDASep 2016approved
EMAMar 2017authorised
CDSCOnot listed
EDEregisteredregistered
Status by market
FDA
United States · Amjevita
US Food and Drug AdministrationApprovedBrand
Amjevita
Holder or applicant
Amgen Inc.
Pathway
351(k)
Approved
Sep 2016
Application or permission
761024
Licence type
351(k) interchangeable, designated Aug 2024
Presentations
10/0.2, 20/0.2, 20/0.4, 40/0.4, 40/0.8, 80/0.8
Source
S001, S016
EMA
European Union · Amgevita
European Medicines Agency and European CommissionApprovedBrand
Amgevita
Holder or applicant
Amgen Europe B.V.
Pathway
Centralised (Article 10(4))
Approved
Mar 2017
Application or permission
EMEA/H/C/004212
Indications as licensed
RA, JIA, axSpA, PsA, psoriasis, HS, Crohn's disease, UC, uveitis
Presentations
see SmPC
Source
S017
EMA
European Union · Solymbic
European Medicines Agency and European CommissionWithdrawnBrand
Solymbic
Holder or applicant
Amgen Europe B.V.
Pathway
Centralised (Article 10(4))
Approved
Mar 2017
Application or permission
EMEA/H/C/004373
Withdrawn
Jun 2018
Presentations
see SmPC
Note
Duplicate authorisation.
Source
S017
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates · Amgevita
Emirates Drug EstablishmentRegisteredBrand
Amgevita
Holder or applicant
Amgen Europe B.V. · UAE supplier Pharmatrade
Pathway
Registered medical product
Registered
not published
Presentations
40 mg pen and syringe
Note
The directory does not give a usable registration date for this product.
Source
S018
Chronology
- FDASep 2016Approved by FDA as Amjevita
- EMAMar 2017Authorised by the European Commission as Amgevita
- EMAJun 2018Solymbic authorisation withdrawn
- FDAJan 2023Amjevita US launch, the first adalimumab biosimilar on the US market
- FDAAug 2024Amjevita 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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