Home/Biosimilar Atlas/Adalimumab/Amjevita / Amgevita

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Brands by market: Amjevita (USA); Amgevita (EU, UAE); Solymbic (EU, withdrawn) · Commercial partner or holder: Amgen · Company profile
FDASep 2016approved
EMAMar 2017authorised
MHRALicenseddate not shown
PMDANot listed
HCNov 2020approved
CDSCONot listed
EDERegistereddate not published
Approved or registered in 5 of 7 markets
Connections
AdalimumabmoleculeAmgendeveloper5 of 7markets1trial behind it7other products, same developer10rival developers in its markets

About Amjevita / Amgevita

Amjevita is Amgen's adalimumab biosimilar, sold as Amgevita in Europe and the Gulf. It was the first adalimumab biosimilar approved in the United States, in September 2016, and the first in Europe, in March 2017. Like every US adalimumab biosimilar it could not launch until January 2023, when the patent settlements with the originator allowed it, and it was the first to reach American pharmacies. It is now interchangeable in the United States and is registered in the UAE. Amgen also holds a second European name, Solymbic, which it withdrew in 2018 as no longer needed. In the UK it is licensed as Amgevita, including the high-concentration form.

Status by market

FDA

United States · Amjevita

US Food and Drug AdministrationApproved
Brand
Amjevita
Holder or applicant
Amgen Inc.
Pathway
351(k)
Approved
Sep 2016
Application or permission
761024
Licence type
351(k) interchangeable, designated Aug 2024
Reference product in the Purple Book
Humira
Marketing status (Purple Book)
Prescription, marketed
Presentations
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 · Amgevita

European Medicines Agency and European CommissionApproved
Brand
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) · checked Sep 2026
EMA

European Union · Solymbic

European Medicines Agency and European CommissionWithdrawn
Brand
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Withdrawn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
Remarks
Duplicate authorisation.
Source
S017 (EMA) · checked Sep 2026
MHRA

United Kingdom · Amgevita

Medicines and Healthcare products Regulatory AgencyApproved
Brand
Amgevita
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, 40 mg syringes and pens; HCF 20, 40 and 80 mg
Source
S023 (MHRA Products) · checked Sep 2026
PMDA

Japan

Not listed by PMDA.

HC

Canada · Amgevita

Health CanadaApproved
Brand
Amgevita
Holder or applicant
Amgen Canada INC
Pathway
Biosimilar biologic drug (Notice of Compliance)
Approved
Nov 2020
Application or permission
DIN 02459299, 02459302, 02459310
Presentations
50 mg
Source
S022 (Health Canada) · checked Sep 2026
CDSCO

India

Not listed by CDSCO.

EDE

United Arab Emirates · Amgevita

Emirates Drug EstablishmentRegistered
Brand
Amgevita
Holder or applicant
Amgen Europe B.V. · UAE supplier Pharmatrade
Pathway
Registered medical product
Registered
not published
Presentations
40 mg pen and syringe
Remarks
The directory does not give a usable registration date for this product.
Source
S018 (UAE Emirates Drug Establishment) · checked Sep 2026

Trials behind this product

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

CandidateDeveloper or sponsorReference productPhaseDesignRegistry statusStartedPrimary completionRegistry record
ABP 501AmgenHumiraPhase 3SwitchingCompletedOct 2021Dec 2022NCT05073315

Other developers in the same markets

Where Amjevita / Amgevita holds an approval, these are the other adalimumab biosimilars approved in that market.

MarketRivalsDevelopers (product)
FDA9Alvotech (Simlandi / Hukyndra / Libmyris), Boehringer Ingelheim (Cyltezo), Celltrion (Yuflyma), Coherus BioSciences (Yusimry), Fresenius Kabi (Idacio), Fujifilm Kyowa Kirin Biologics (Hulio), Pfizer (Abrilada / Amsparity), Samsung Bioepis (Hadlima / Imraldi), Sandoz (Hyrimoz / Hefiya)
EMA7Alvotech (Simlandi / Hukyndra / Libmyris), Celltrion (Yuflyma), Fresenius Kabi (Idacio), Fujifilm Kyowa Kirin Biologics (Hulio), Pfizer (Abrilada / Amsparity), Samsung Bioepis (Hadlima / Imraldi), Sandoz (Hyrimoz / Hefiya)
MHRA7Alvotech (Simlandi / Hukyndra / Libmyris), Celltrion (Yuflyma), Fresenius Kabi (Idacio), Fujifilm Kyowa Kirin Biologics (Hulio), Not stated in the MHRA list (Qletli), Samsung Bioepis (Hadlima / Imraldi), Sandoz (Hyrimoz / Hefiya)
HC7Alvotech (Simlandi / Hukyndra / Libmyris), Celltrion (Yuflyma), Fresenius Kabi (Idacio), Fujifilm Kyowa Kirin Biologics (Hulio), Pfizer (Abrilada / Amsparity), Samsung Bioepis (Hadlima / Imraldi), Sandoz (Hyrimoz / Hefiya)
EDE3Fresenius Kabi (Idacio), Fujifilm Kyowa Kirin Biologics (Hulio), Sandoz (Hyrimoz / Hefiya)

Same developer, other molecules

Other biosimilars in the Atlas developed by Amgen: Avsola, Bkemv / Bekemv, Kanjinti, Mvasi, Pavblu, Riabni, Wezlana / Wezenla.

Chronology

Sources

All adalimumab biosimilars

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Data current to September 2026.