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

Title	Posted	Study ID	Phase	Status	Sponsor
Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty	2025/08/24	NCT07138898	Not Applicable	Not yet recruiting	NYU Langone Health
Evaluation of IL 12B Genetic Polymorphism (rs3213094)	2025/08/19	NCT07128472	Not Applicable	Recruiting	South Valley University
Characteristics of Ankylosing Spondylitis Associated Uveitis	2025/08/11	NCT07113834	N/A	Completed	Benha University
A Randomized Phase 1/2 Trial of Low Dose Anti-thymocyte Globulin (ATG) With Subsequent Adalimumab or Verapamil in New Onset Type 1 Diabetes	2025/07/11	NCT07061574	Not Applicable	Not yet recruiting	City of Hope Medical Center
The Efficacy and Safety of Deucravacitinib in Takayasu's Arteritis	2025/06/10	NCT07013838	Phase 4	Not yet recruiting	Chinese SLE Treatment And Research Group
An Exploratory Study of the Potential for Rational Immune System Manipulation to Prevent Emergence of Synucleinopathy Manifestations in Persons With REM Sleep Behavior Disorder (RBD)	2025/05/30	NCT06996652	Phase 2	Not yet recruiting	Yale University
An Open-Label Study of Effectiveness of Immunomodulatory Medications for Patients With Relapsing Polychondritis	2025/04/23	NCT06941376	Phase 2	Not yet recruiting	University of Pennsylvania
Subconjunctival Humira for Boston Keratoprosthesis	2025/04/13	NCT06926478	Phase 1	Not yet recruiting	Massachusetts Eye and Ear Infirmary
Baricitinib in the Treatment of Intestinal Behçet's Syndrome	2025/02/27	NCT06849908	Phase 2	Recruiting	Peking Union Medical College Hospital
Interleukin-17 (IL-17) Inhibitor in Combination With Tumor Necrosis Factor α (TNFα )Inhibitor for the Treatment of Ankylosing Spondylitis	2025/02/18	NCT06833112	Phase 4	Not yet recruiting	The Affiliated Hospital Of Guizhou Medical University

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Adalimumab	CELLTRION USA, Inc.	72606-040	SUBCUTANEOUS	80 mg in 0.8 mL	12/8/2023
HYRIMOZ	Cordavis Limited	83457-100	SUBCUTANEOUS	40 mg in 0.4 mL	6/15/2023
HYRIMOZ	Cordavis Limited	83457-108	SUBCUTANEOUS	20 mg in 0.2 mL	6/15/2023
HYRIMOZ	Cordavis Limited	83457-101	SUBCUTANEOUS	40 mg in 0.4 mL	6/15/2023
AMJEVITA	Amgen Inc	55513-480	SUBCUTANEOUS	80 mg in 0.8 mL	8/18/2023
Humira	AbbVie Inc.	0074-3797	SUBCUTANEOUS	40 mg in 0.8 mL	7/16/2025
AMJEVITA	Amgen Inc	55513-399	SUBCUTANEOUS	20 mg in 0.2 mL	8/18/2023
Adalimumab	Sandoz Inc	61314-391	SUBCUTANEOUS	10 mg in 0.1 mL	11/21/2024
Adalimumab	Sandoz Inc.	61314-391	SUBCUTANEOUS	10 mg in 0.1 mL	11/21/2024
YUSIMRY	Coherus BioSciences Inc	70114-210	SUBCUTANEOUS	40 mg in 0.8 mL	2/28/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Hefiya	Sandoz GmbH,Biochemiestrasse 10,6250 Kundl,Austria	Authorised	7/26/2018
Hulio	Biosimilar Collaborations Ireland Limited,Unit 35/36,Grange Parade,,Baldoyle Industrial Estate,Dublin 13,DUBLIN,D13 R20R,Ireland	Authorised	9/17/2018
Yuflyma	Celltrion Healthcare Hungary Kft.,1062 Budapest,Váci út 1-3. WestEnd Office Building B torony,Hungary	Authorised	2/11/2021
Hyrimoz	Sandoz GmbH,Biochemiestrasse 10,6250 Kundl,Austria	Authorised	7/26/2018
Imraldi	Samsung Bioepis NL B.V.,Olof Palmestraat 10,2616 LR Delft,The Netherlands	Authorised	8/24/2017
Hukyndra	Stada Arzneimittel AG,Stadastrasse 2-18,D-61118 Bad Vilbel,Germany	Authorised	11/15/2021
Hukyndra	Stada Arzneimittel AG,Stadastrasse 2-18,D-61118 Bad Vilbel,Germany	Authorised	11/15/2021
Amsparity	Pfizer Europe MA EEIG,Boulevard de la Plaine 17,1050 Bruxelles,Belgium	Authorised	2/13/2020
Amsparity	Pfizer Europe MA EEIG,Boulevard de la Plaine 17,1050 Bruxelles,Belgium	Authorised	2/13/2020
Amgevita	Amgen Europe B.V.,Minervum 7061,NL-4817 ZK Breda,Netherlands	Authorised	3/21/2017

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
AMGEVITA SOLUTION FOR INJECTION IN PREFILLED SYRINGE 40 mg/0.8 ml	Amgen Manufacturing Limited	SIN15731P	INJECTION, SOLUTION	40 mg/0.8 ml	7/2/2019
ABRILADA SOLUTION FOR INJECTION IN SINGLE-DOSE PREFILLED SYRINGE 20 MG/0.4 ML	Catalent Indiana, LLC	SIN16561P	INJECTION, SOLUTION	20mg/0.4ml	8/2/2022
HUMIRA SOLUTION FOR INJECTION 40MG/0.8ML (PRE-FILLED SYRINGE)	VETTER PHARMA-FERTIGUNG GMBH & CO KG (Ravensburg)	SIN15787P	INJECTION	40mg/0.8ml	8/26/2019
IDACIO SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 40MG/0.8ML	Merck Serono S.p.A. (Bari)	SIN16084P	INJECTION, SOLUTION	40mg/0.8ml	1/25/2021
HUMIRA SOLUTION FOR INJECTION 80MG/0.8ML (PREFILLED SYRINGE)	Vetter Pharma-Fertigung GmbH & Co. KG (Schützenstrasse), AbbVie Biotechnology Ltd (ABL)	SIN15915P	INJECTION, SOLUTION	80.0mg/0.8mL	3/19/2020
HUMIRA SOLUTION FOR INJECTION 20MG/0.2ML (PRE-FILLED SYRINGE)	Vetter Pharma-Fertigung GmbH & Co. KG (Ravensburg)	SIN15718P	INJECTION, SOLUTION	20.0mg/0.2mL	6/17/2019
HUMIRA SOLUTION FOR INJECTION 80MG/0.8ML (PREFILLED PEN)	Vetter Pharma-Fertigung GmbH & Co. KG (Schützenstrasse), AbbVie Biotechnology Ltd (ABL)	SIN15914P	INJECTION, SOLUTION	80.0mg/0.8mL	3/19/2020
IDACIO SOLUTION FOR INJECTION FOR PAEDIATRIC USE 40MG/0.8ML VIAL	Merck Serono S.A (Aubonne)	SIN16085P	INJECTION, SOLUTION	40mg/0.8ml	1/25/2021
HULIO SOLUTION FOR INJECTION 40 MG/0.8 ML IN PRE-FILLED SYRINGE	Terumo Yamaguchi D&D Corporation (Drug Product Manufacturer & Primary Packager)	SIN16360P	INJECTION, SOLUTION	40 mg/0.8ml	11/2/2021
HUMIRA SOLUTION FOR INJECTION 40MG/0.4ML (PRE-FILLED SYRINGE)	Vetter Pharma-Fertigung GmbH & Co. KG (Ravensburg), AbbVie Biotechnology Ltd	SIN15786P	INJECTION, SOLUTION	40mg/0.4ml	8/26/2019

NMPA Drug Approvals

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

PPB Drug Approvals

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

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
AMGEVITA adalimumab (rch) 40mg/0.8mL injection solution syringe	278701	Amgen Australia Pty Ltd	Medicine	A	11/9/2017
HYRIMOZ adalimumab 20 mg/0.2 mL solution for injection pre-filled syringe	407662	Sandoz Pty Ltd	Medicine	A	5/15/2024
HULIO adalimumab (rch) 40 mg/0.8 mL solution for injection pre-filled syringe	334802	Maxx Pharma Pty Ltd	Medicine	A	5/14/2021
ADALICIP adalimumab 80 mg/0.8 mL solution for subcutaneous injection pre-filled syringe	374377	Cipla Australia Pty Ltd	Medicine	A	9/6/2022
HULIO adalimumab (rch) 40 mg/0.8 mL solution for injection pre-filled pen	334800	Maxx Pharma Pty Ltd	Medicine	A	5/14/2021
YUFLYMA adalimumab 80 mg/0.8 mL solution for injection pre-filled syringe	396990	Celltrion Healthcare Australia Pty Ltd	Medicine	A	6/30/2023
AMGEVITA adalimumab (rch) 40mg/0.8mL injection solution syringe within a pen injector	273536	Amgen Australia Pty Ltd	Medicine	A	11/9/2017
HYRIMOZ adalimumab 40 mg/0.4 mL solution for injection pre-filled syringe	407872	Sandoz Pty Ltd	Medicine	A	5/15/2024
CIPTUNEC adalimumab 40 mg/0.4 mL solution for subcutaneous injection pre-filled pen	374373	Cipla Australia Pty Ltd	Medicine	A	9/6/2022
HULIO adalimumab (rch) 20 mg/0.4 mL solution for injection pre-filled syringe	334801	Maxx Pharma Pty Ltd	Medicine	A	5/14/2021

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
SIMLANDI	Jamp Pharma Corporation	02523957	Solution - Subcutaneous	40 MG / 0.4 ML	4/13/2022
YUFLYMA	Celltrion Inc	02535084	Solution - Subcutaneous	80 MG / 0.8 ML	8/14/2023
ABRILADA	Pfizer Canada Ulc	02511053	Solution - Subcutaneous	40 MG / 0.8 ML	3/7/2022
IDACIO	fresenius kabi canada ltd	02502682	Solution - Subcutaneous	40 MG / 0.8 ML	8/30/2021
AMGEVITA	Amgen Canada Inc	02459302	Solution - Subcutaneous	50 MG / ML	2/19/2021
HADLIMA PUSHTOUCH	Samsung Bioepis Co., Ltd.	02473100	Solution - Subcutaneous	40 MG / 0.8 ML	2/19/2021
HADLIMA PUSHTOUCH	Samsung Bioepis Co., Ltd.	02533480	Solution - Subcutaneous	40 MG / 0.4 ML	10/25/2023
HUMIRA	Abbvie Corporation	02258595	Solution - Subcutaneous	40 MG / 0.8 ML	9/24/2004
AMGEVITA	Amgen Canada Inc	02459299	Solution - Subcutaneous	50 MG / ML	2/19/2021
ABRILADA	Pfizer Canada Ulc	02511088	Solution - Subcutaneous	10 MG / 0.2 ML	N/A

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
HYRIMOZ 40 MG SOLUCION INYECTABLE EN PLUMA PRECARGADA	Sandoz Gmbh	1181286015	SOLUCIÓN INYECTABLE Y PARA PERFUSIÓN EN JERINGA PRECARGADA	Diagnóstico Hospitalario	Commercialized
YUFLYMA 40 MG SOLUCION INYECTABLE EN JERINGA PRECARGADA	Celltrion Healthcare Hungary Kft.	1201513006	SOLUCIÓN INYECTABLE	Diagnóstico Hospitalario	Not Commercialized
HUMIRA 20 MG SOLUCION INYECTABLE EN JERINGA PRECARGADA	Abbvie Deutschland Gmbh & Co. Kg	103256022	SOLUCIÓN INYECTABLE EN JERINGA PRECARGADA	Diagnóstico Hospitalario	Commercialized
HYRIMOZ 40 MG SOLUCION INYECTABLE EN JERINGA PRECARGADA	Sandoz Gmbh	1181286001	SOLUCIÓN INYECTABLE EN JERINGA PRECARGADA	Diagnóstico Hospitalario	Not Commercialized
HUMIRA 40 MG SOLUCIÓN INYECTABLE EN PLUMA PRECARGADA	Abbvie Deutschland Gmbh & Co. Kg	103256017	SOLUCIÓN INYECTABLE EN PLUMA PRECARGADA	Diagnóstico Hospitalario	Commercialized
YUFLYMA 80 MG SOLUCION INYECTABLE EN JERINGA PRECARGADA	Celltrion Healthcare Hungary Kft.	1201513014	SOLUCIÓN INYECTABLE EN JERINGA PRECARGADA	Diagnóstico Hospitalario	Not Commercialized
HUMIRA 40 mg SOLUCION INYECTABLE EN JERINGA PRECARGADA	Abbvie Deutschland Gmbh & Co. Kg	03256003	SOLUCIÓN INYECTABLE EN JERINGA PRECARGADA	Diagnóstico Hospitalario	Not Commercialized
AMGEVITA 20 MG SOLUCION INYECTABLE EN JERINGA PRECARGADA	Amgen Europe B.V.	1161164001	SOLUCIÓN INYECTABLE EN JERINGA PRECARGADA	Diagnóstico Hospitalario	Not Commercialized
HULIO 40 MG SOLUCION INYECTABLE EN JERINGA PREGARGADA	Biosimilar Collaborations Ireland Limited	1181319002	SOLUCIÓN INYECTABLE Y PARA PERFUSIÓN EN JERINGA PRECARGADA	Diagnóstico Hospitalario	Commercialized
HUKYNDRA 40 MG SOLUCION INYECTABLE EN PLUMA PRECARGADA	Stada Arzneimittel Ag	1211589004	SOLUCIÓN INYECTABLE EN PLUMA PRECARGADA	Diagnóstico Hospitalario	Not Commercialized

Philippines FDA Drug Approvals

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

Saudi SFDA Drug Approvals

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

Malaysia NPRA Drug Approvals

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

UK EMC Drug Information

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

Real-World Study Shows Adalimumab Biosimilar IBI303 Matches Humira Efficacy with Superior Cost Benefits in Ankylosing Spondylitis

a month ago

A retrospective study of 106 patients with ankylosing spondylitis in China found IBI303 biosimilar demonstrated comparable safety to Humira with higher retention rates at 52 weeks (63% vs 44%).

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Overview

Indication

Associated Conditions

Clinical Trials

FDA Drug Approvals

EMA Drug Approvals

HSA Drug Approvals

NMPA Drug Approvals

PPB Drug Approvals

TGA Drug Approvals

Health Canada Drug Approvals

CIMA AEMPS Drug Approvals

Philippines FDA Drug Approvals

Saudi SFDA Drug Approvals

Malaysia NPRA Drug Approvals

UK EMC Drug Information

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Real-World Study Shows Adalimumab Biosimilar IBI303 Matches Humira Efficacy with Superior Cost Benefits in Ankylosing Spondylitis

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