Adalimumab

Overview

Adalimumab is a subcutaneously administered biological disease modifier for the treatment of rheumatoid arthritis and other chronic debilitating diseases mediated by tumor necrosis factor. It was originally launched by Abbvie in the U.S. and approved in 2002 by the FDA. This drug is frequently known as Humira. It is produced by recombinant DNA technology using a mammalian cell expression system. This drug is available in a prefilled syringe form and convenient pen form for subcutaneous self-administered doses. Several biosimilars to adalimumab. Adalimumab-atto was the first adalimumab biosimilar approved by the FDA in 2016. Adalimumab-adaz was approved by the FDA on October 31, 2018. Other biosimilars include adalimumab-fkjp, which was approved in July 2022, and adalimumab-bwwd, which was approved in August 2022. A biosimilar marketed as Hyrimoz, a high-concentration formulation of adalimumab, is also available.

Indication

Adalimumab is indicated for the following conditions: Adalimumab has also been used off-label to treat Pyoderma gangrenosum.

Associated Conditions

Ankylosing Spondylitis (AS)
Hidradenitis Suppurativa (HS)
Moderate to Severe Chronic Plaque Psoriasis
Moderate to Severe Rheumatoid Arthritis
Moderately to Severely Active Crohn's Disease
Moderately to Severely Active Ulcerative Colitis
Non-infectious Intermediate, Posterior and Panuveitis
Polyarticular Juvenile Idiopathic Arthritis
Psoriatic Arthritis
Pyoderma Gangrenosum

Clinical Trials

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Title	Posted	Study ID	Phase	Status	Sponsor
Filgotinib Effect on Proteomic Profile and Micro-RNA Expression in Patients With Active Rheumatoid Arthritis (RA)	2024/07/30	NCT06527534	Phase 4	Recruiting	Universita di Verona
A Randomized, Controlled, Open-label, Multicenter Clinical Trial Comparing the Efficacy and Safety of a Precision Treatment Regimen Based on Clinical-molecular Phenotypes with a Conventional Treatment Regimen in the Treatment of Patients with Active Takayasu's Arteritis	2024/07/12	NCT06498089	Phase 4	Recruiting	Shanghai Zhongshan Hospital
Therapeutic Drug Monitoring-baSed adalimuMab De-escalatiOn in nOn-infecTious cHronic Uveitis	2024/04/30	NCT06390436	Phase 4	Not yet recruiting	Centre Hospitalier Universitaire de Saint Etienne
Evaluation of TWEAK in Plaque Psoriasis and Psoriatic Arthritis Patients	2024/04/17	NCT06370156	N/A	Not yet recruiting	Egymedicalpedia
Study of the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of BCD-180 in Patients With Axial Spondyloarthritis (LEVENTA)	2024/03/27	NCT06333210	Phase 3	Active, not recruiting	Biocad
Effect of Immunosuppressants With Adalimumab Biosimilars vs Corticosteroids on Noninfectious Uveitis	2024/03/15	NCT06310837	Not Applicable	Active, not recruiting	Zhongshan Ophthalmic Center, Sun Yat-sen University
Comparison Between Infliximab and Adalimumab on Patients With Ulcerative Colitis	2024/02/21	NCT06269185	N/A	Completed	Vastra Gotaland Region
A Study to Assess Adverse Events and Change in Disease Activity From Intravenous (IV) and Subcutaneous (SC) Lutikizumab in Adult Participants With Active Ulcerative Colitis	2024/02/14	2023-505678-14-00	Phase 2	Active, not recruiting	AbbVie Deutschland GmbH & Co. KG
Treatment FOr Corticosteroid Dependent UveitiS	2024/02/14	NCT06258915	Phase 3	Not yet recruiting	Assistance Publique - Hôpitaux de Paris
A Study to Evaluate 608 in Patients with Ankylosing Spondylitis (AS)	2024/02/05	NCT06242652	Phase 2	Active, not recruiting	Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

FDA Drug Approvals

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Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Idacio	Fresenius Kabi USA, LLC	65219-556	SUBCUTANEOUS	40 mg in 0.8 mL	12/31/2022
AMJEVITA	Amgen Inc	55513-400	SUBCUTANEOUS	40 mg in 0.8 mL	8/18/2023
HYRIMOZ	Cordavis Limited	83457-113	SUBCUTANEOUS	80 mg in 0.8 mL	6/15/2023
HADLIMA	A-S Medication Solutions	50090-6706	SUBCUTANEOUS	40 mg in 0.8 mL	11/25/2022
ABRILADA	Pfizer Laboratories Div Pfizer Inc	0025-0319	SUBCUTANEOUS	40 mg in 0.8 mL	10/18/2023
HYRIMOZ	Cordavis Limited	83457-103	SUBCUTANEOUS	40 mg in 0.8 mL	6/15/2023
Yuflyma	CELLTRION USA, Inc.	72606-024	SUBCUTANEOUS	20 mg in 0.2 mL	12/1/2023
AMJEVITA	Amgen USA Inc.	72511-400	SUBCUTANEOUS	40 mg in 0.8 mL	8/14/2023
Adalimumab	Sandoz Inc	61314-332	SUBCUTANEOUS	20 mg in 0.2 mL	11/21/2024
Adalimumab	Sandoz Inc.	61314-332	SUBCUTANEOUS	20 mg in 0.2 mL	11/21/2024

EMA Drug Approvals

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Approved Product	Authorization Holder	Status	Issued Date
Idacio	Fresenius Kabi Deutschland GmbH,Else-Kroner-Strasse 1,61352 Bad Homburg v.d.H.,Germany	Authorised	4/2/2019
Idacio	Fresenius Kabi Deutschland GmbH,Else-Kroner-Strasse 1,61352 Bad Homburg v.d.H.,Germany	Authorised	4/2/2019
Libmyris	Stada Arzneimittel AG,Stadastrasse 2-18,D-61118 Bad Vilbel,Germany	Authorised	11/12/2021
Libmyris	Stada Arzneimittel AG,Stadastrasse 2-18,D-61118 Bad Vilbel,Germany	Authorised	11/12/2021
Libmyris	Stada Arzneimittel AG,Stadastrasse 2-18,D-61118 Bad Vilbel,Germany	Authorised	11/12/2021

HSA Drug Approvals

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Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
HUMIRA SOLUTION FOR INJECTION 40MG/0.4ML (PRE-FILLED PEN)	Vetter Pharma-Fertigung GmbH & Co. KG (Ravensburg), AbbVie Biotechnology Ltd	SIN15248P	INJECTION, SOLUTION	40.0 mg	5/26/2017
AMGEVITA SOLUTION FOR INJECTION IN PREFILLED SYRINGE 20 mg/0.4 ml	Amgen Manufacturing Limited	SIN15732P	INJECTION, SOLUTION	20 mg/0.4 ml	7/2/2019
YUFLYMA SOLUTION FOR INJECTION IN PRE-FILLED PEN 40MG/0.4ML	Catalent Belgium S.A.	SIN16508P	INJECTION, SOLUTION	40 mg/0.4ml	6/9/2022
HUMIRA SOLUTION FOR INJECTION 40MG/0.8ML (PRE-FILLED PEN)	VETTER PHARMA-FERTIGUNG GMBH & CO KG (Ravensburg), Vetter Pharma-Fertigung GmbH & Co. KG (Langenargen)	SIN12360P	INJECTION	40mg	7/22/2003
HUMIRA SOLUTION FOR INJECTION 40MG/0.8ML (VIAL)	Vetter Pharma-Fertigung GmbH & Co. KG (Langenargen)	SIN14626P	INJECTION	40.0 mg	9/19/2014
ABRILADA SOLUTION FOR INJECTION IN SINGLE-DOSE PREFILLED PEN 40 MG/0.8 ML	Catalent Indiana, LLC	SIN16562P	INJECTION, SOLUTION	40mg/0.8ml	8/2/2022
ABRILADA SOLUTION FOR INJECTION IN SINGLE-DOSE PREFILLED SYRINGE 40 MG/0.8 ML	Catalent Indiana, LLC	SIN16563P	INJECTION, SOLUTION	40mg/0.8ml	8/2/2022
IDACIO SOLUTION FOR INJECTION IN PRE-FILLED PEN 40MG/0.8ML	Merck Serono S.p.A. (Bari)	SIN16083P	INJECTION, SOLUTION	40mg/0.8ml	1/25/2021
HYRIMOZ SOLUTION FOR INJECTION IN PRE-FILLED PEN 40MG/0.8ML	Sandoz GmbH	SIN16273P	INJECTION, SOLUTION	40 mg/0.8 mL	7/8/2021
AMGEVITA SOLUTION FOR INJECTION IN PREFILLED AUTOINJECTOR 40 mg/0.8 ml	Amgen Manufacturing Limited	SIN15760P	INJECTION, SOLUTION	40mg/0.8ml	7/31/2019

NMPA Drug Approvals

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Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

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Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

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Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
ABRILADA adalimumab 20 mg solution for injection pre-filled syringe	334496	Pfizer Australia Pty Ltd	Medicine	A	2/22/2021
ADALICIP adalimumab 40 mg/0.4 mL solution for subcutaneous injection pre-filled syringe	374375	Cipla Australia Pty Ltd	Medicine	A	9/6/2022
IDACIO adalimumab (rch) 40 mg solution for injection pre-filled syringe	320241	Fresenius Kabi Australia Pty Ltd	Medicine	A	6/17/2020
IDACIO adalimumab (rch) 40 mg solution for injection pre-filled pen	320242	Fresenius Kabi Australia Pty Ltd	Medicine	A	6/17/2020
YUFLYMA adalimumab 80 mg/0.8 mL solution for injection pre-filled syringe in auto injector pen	396992	Celltrion Healthcare Australia Pty Ltd	Medicine	A	6/30/2023
YUFLYMA adalimumab (rch) 20 mg/0.2 mL solution for injection pre-filled syringe	438910	Celltrion Healthcare Australia Pty Ltd	Medicine	A	9/26/2024
HYRIMOZ adalimumab 80 mg/0.8 mL solution for injection pre-filled pen	407873	Sandoz Pty Ltd	Medicine	A	5/15/2024
CIPTUNEC adalimumab 40 mg/0.4 mL solution for subcutaneous injection pre-filled syringe	373065	Cipla Australia Pty Ltd	Medicine	A	9/6/2022
YUFLYMA adalimumab (rch) 40 mg/0.4 mL solution for injection pre-filled syringe in autoinjector	367771	Celltrion Healthcare Australia Pty Ltd	Medicine	A	3/25/2022
HUMIRA adalimumab 40 mg/0.4 mL solution for injection pre-filled syringe	281470	AbbVie Pty Ltd	Medicine	A	11/16/2017

Health Canada Drug Approvals

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Approved Product	Company	DIN	Dosage Form	Strength	Market Date
SIMLANDI	Jamp Pharma Corporation	02523965	Solution - Subcutaneous	80 MG / 0.8 ML	5/19/2022
YUFLYMA	Celltrion Inc	02523760	Solution - Subcutaneous	40 MG / 0.4 ML	3/6/2023
HUMIRA	Abbvie Corporation	02474263	Solution - Subcutaneous	20 MG / 0.2 ML	8/18/2020
HULIO	Biosimilar Collaborations Ireland Ltd.	02502402	Solution - Subcutaneous	40 MG / 0.8 ML	2/16/2021
HADLIMA	Samsung Bioepis Co., Ltd.	02533472	Solution - Subcutaneous	40 MG / 0.4 ML	10/25/2023
YUFLYMA	Celltrion Inc	02523779	Solution - Subcutaneous	40 MG / 0.4 ML	3/3/2022
HUMIRA	Abbvie Corporation	02458349	Solution - Subcutaneous	40 MG / 0.4 ML	11/14/2016
HYRIMOZ	Sandoz Canada, Inc.	02542331	Solution - Subcutaneous	40 MG / 0.4 ML	4/17/2024
IDACIO	fresenius kabi canada ltd	02502674	Solution - Subcutaneous	40 MG / 0.8 ML	2/16/2021
SIMLANDI	Jamp Pharma Corporation	02523949	Solution - Subcutaneous	40 MG / 0.4 ML	5/19/2022

CIMA AEMPS Drug Approvals

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Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
HULIO 40 MG/0,8 ML SOLUCION INYECTABLE	Biosimilar Collaborations Ireland Limited	1181319007	SOLUCIÓN INYECTABLE	Diagnóstico Hospitalario	Not Commercialized
HYRIMOZ 40 MG SOLUCION INYECTABLE EN PLUMA PRECARGADA	Sandoz Gmbh	1181286004	SOLUCIÓN INYECTABLE EN PLUMA PRECARGADA	Diagnóstico Hospitalario	Not Commercialized
IDACIO 40 MG SOLUCION INYECTABLE EN PLUMA PRECARGADA	Fresenius Kabi Deutschland Gmbh	1191356003	SOLUCIÓN INYECTABLE EN PLUMA PRECARGADA	Diagnóstico Hospitalario	Commercialized
AMGEVITA 40 MG SOLUCION INYECTABLE EN JERINGA PRECARGADA	Amgen Europe B.V.	1161164012	SOLUCIÓN INYECTABLE	Diagnóstico Hospitalario	Commercialized
Humira 40mg solucion inyectable en jeringa precargada	Abbvie Deutschland Gmbh & Co. Kg	103256013	SOLUCIÓN INYECTABLE EN JERINGA PRECARGADA	Diagnóstico Hospitalario	Commercialized
HUMIRA 80 MG SOLUCION INYECTABLE EN PLUMA PRECARGADA	Abbvie Deutschland Gmbh & Co. Kg	103256021	SOLUCIÓN INYECTABLE	Diagnóstico Hospitalario	Commercialized
IMRALDI 40 MG SOLUCION INYECTABLE EN PLUMA PRECARGADA	Samsung Bioepis Nl B.V.	1171216005	SOLUCIÓN INYECTABLE EN PLUMA PRECARGADA	Diagnóstico Hospitalario	Not Commercialized
AMGEVITA 40 MG SOLUCION INYECTABLE EN JERINGA PRECARGADA	Amgen Europe B.V.	1161164002	SOLUCIÓN INYECTABLE EN JERINGA PRECARGADA	Diagnóstico Hospitalario	Not Commercialized
HYRIMOZ 40 MG SOLUCION INYECTABLE EN JERINGA PRECARGADA	Sandoz Gmbh	1181286012	SOLUCIÓN INYECTABLE Y PARA PERFUSIÓN EN JERINGA PRECARGADA	Diagnóstico Hospitalario	Commercialized
HUKYNDRA 40 MG SOLUCION INYECTABLE EN JERINGA PRECARGADA	Stada Arzneimittel Ag	1211589001	SOLUCIÓN INYECTABLE EN JERINGA PRECARGADA	Diagnóstico Hospitalario	Not Commercialized

Philippines FDA Drug Approvals

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Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

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Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

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Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

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Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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