Adalimumab is a monoclonal anti-tumor necrosis factor alpha antibody used in the treatment of a wide variety of inflammatory conditions such as rheumatoid arthritis, Crohn's disease, and ankylosing spondylitis.

Brand Names
Amjevita, Cyltezo, Humira, Hyrimoz, Simlandi, Yusimry
Generic Name
DrugBank Accession Number

Adalimumab is a subcutaneously administered biological disease modifier for the treatment of rheumatoid arthritis and other chronic debilitating diseases mediated by tumor necrosis factor.2,3 It was originally launched by Abbvie in the U.S. and approved in 2002 by the FDA.1 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.1

Several biosimilars to adalimumab. Adalimumab-atto was the first adalimumab biosimilar approved by the FDA in 2016.19 Adalimumab-adaz was approved by the FDA on October 31, 2018.12 Other biosimilars include adalimumab-fkjp - which was approved in July 2022 -,17 adalimumab-bwwd - which was approved in August 2022 -,18 and adalimumab-aacf - which was approved in October 2023.31 A biosimilar marketed as Hyrimoz, a high-concentration formulation of adalimumab, is also available.20,21

Approved, Experimental
Biologic Classification
Protein Based Therapies
Monoclonal antibody (mAb)
Protein Structure
Protein Chemical Formula
Protein Average Weight
144190.3 Da
> Adalimumab Light chain:
> Adalimumab Heavy chain:
Download FASTA Format
  • Adalimumab
  • Adalimumab (genetical recombination)
  • adalimumab-adaz
  • adalimumab-adbm
  • adalimumab-afzb
  • adalimumab-atto
  • adalimumab-bwwd
  • adalimumab-fkjp
External IDs
  • ABP-501
  • BCD-057
  • BI-695501
  • BI695501
  • CHS-1420
  • D2E7
  • FKB327
  • GP-2017
  • GP2017
  • LU-200134
  • LU200134
  • M-923
  • M923
  • MSB-11022
  • MSB11022
  • ONS-3010
  • SB-5
  • SB5



Adalimumab is indicated for the following conditions:31

  • Moderately to severely active Rheumatoid Arthritis (RA) in adults, as monotherapy or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs).16,17,18,19,20,21,31
  • Moderately to severely active polyarticular Juvenile Idiopathic Arthritis (JIA) in patients two years of age and older, as monotherapy or in combination with methotrexate.16,17,18,19,20,21,31
  • Psoriatic Arthritis (PsA) in adults.16,17,18,19,20,21,31
  • Ankylosing Spondylitis (AS) in adults.16,17,18,19,20,21,31
  • Moderately to severely active Crohn’s Disease (CD) in adults and pediatric patients six years of age and older.16,17,18,19,20,21,31
  • Moderately to severely active Ulcerative Colitis (UC) in adults. Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers.16,17,18,19,20,21,31
  • Moderate to severe chronic plaque psoriasis in adult candidates for systemic therapy or phototherapy and when other systemic therapies are medically less appropriate.16,17,18,19,20,21,31
  • Moderate to severe Hidradenitis Suppurativa (HS) in adults.19
  • Non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients two years of age and older.15

Adalimumab has also been used off-label to treat Pyoderma gangrenosum.5,6

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Associated Conditions
Indication TypeIndicationCombined Product DetailsApproval LevelAge GroupPatient CharacteristicsDose Form
Management ofAnkylosing spondylitis (as)••••••••••••••••••••••••••
Treatment ofHidradenitis suppurativa (hs)••••••••••••••••••••••••••
Treatment ofModerate to severe chronic plaque psoriasis••••••••••••••••••••••••• •• •••••• ••••••• •••••• ••••••••• ••• ••• •••••••••• ••• •••••••• ••••••• •• ••••••••••••• ••• •••• ••••• •••••••• ••••••••• ••• ••••••••• •••• ••••••••••••••••••••
Used in combination to manageModerate to severe rheumatoid arthritisRegimen in combination with: Methotrexate (DB00563)••••••••••••••••••••••••••
Management ofModerate to severe rheumatoid arthritis••••••••••••••••••••••••••
Contraindications & Blackbox Warnings
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After treatment with adalimumab, a decrease in levels of acute phase reactant proteins of inflammation (C­ reactive protein [CRP] and erythrocyte sedimentation rate [ESR]) and serum cytokines (IL-6) was measured compared to baseline in patients diagnosed with rheumatoid arthritis. A decrease in CRP levels was also observed in patients diagnosed with Crohn’s disease. Serum levels of matrix metalloproteinases (MMP-1 and MMP-3) that lead to the tissue remodeling responsible for cartilage destruction were also found to be decreased after administration of adalimumab.15 A reduction in signs and symptoms of disease, the induction of clinical response, inhibition of structural damage, and improvements in physical function in adult and pediatric patients with various inflammatory conditions have been demonstrated.1,3,15

Mechanism of action

Adalimumab binds with specificity to tumor necrosis factor-alpha (TNF-alpha) and inhibits its interaction with the p55 and p75 cell surface TNF receptors. Adalimumab also lyses surface tumor necrosis factor expressing cells in vitro when in the presence of complement.2,3 Adalimumab does not bind or inactivate lymphotoxin (Tumor necrosis factor-beta). TNF is a naturally occurring cytokine that plays a role in normal inflammatory and immune responses.3 Increased levels of TNF are found in the joint synovial fluid of rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis patients, and play an imperative role in pathologic inflammation and joint destruction that are major complications of these diseases. Increased levels of TNF are also measured in psoriasis plaques. In plaque psoriasis, treatment with adalimumab may decrease the epidermal thickness and inflammatory cell infiltration. The relationship between these pharmacodynamics and the mechanism(s) by which adalimumab achieves its clinical effects is not known. Additionally, adalimumab alters biological responses that are induced/regulated by TNF, including changes in the levels of adhesion molecules responsible for leukocyte migration during inflammation (ELAM-1, VCAM-1, and ICAM-1 with an IC50 of 1-2 X 10-10M).15

ATumor necrosis factor

The maximum serum concentration (Cmax) and the time to reach the maximum concentration (Tmax) were 4.7 ± 1.6 μg/mL and 131 ± 56 hours respectively, following a single 40 mg subcutaneous administration of adalimumab to healthy adult subjects. The average absolute bioavailability of adalimumab estimated from three clinical studies after a single 40 mg subcutaneous dose of adalimumab was 64%. The pharmacokinetics of adalimumab showed a linear pattern over the dose range of 0.5 to 10.0 mg/kg following a single intravenous dose.15

Volume of distribution

The distribution volume (Vss) ranged from 4.7 to 6.0 L following intravenous administration of doses ranging from 0.25 to 10 mg/kg in RA patients.15

Protein binding

Not Available

Not Available
Route of elimination

Adalimumab is most likely removed by opsonization via the reticuloendothelial system.7


The mean terminal half-life was approximately 2 weeks, ranging from 10 to 20 days across studies.15


The single-dose pharmacokinetics of adalimumab in RA patients were determined in several studies with intravenous doses ranging from 0.25 to 10 mg/kg. The systemic clearance of adalimumab is approximately 12 mL/hr. In long-term studies with dosing more than two years, there was no evidence of changes in clearance over time in RA patients.15

Adverse Effects
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Doses up to 10 mg/kg have been administered to patients in clinical trials without evidence of dose-limiting toxicities. In case of overdosage, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions or effects and appropriate symptomatic treatment instituted immediately.16

Not Available
Pharmacogenomic Effects/ADRs
Not Available


Drug Interactions
This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.
AbataceptThe risk or severity of infection can be increased when Adalimumab is combined with Abatacept.
AbciximabThe risk or severity of adverse effects can be increased when Adalimumab is combined with Abciximab.
AbemaciclibThe metabolism of Abemaciclib can be increased when combined with Adalimumab.
AbrocitinibThe metabolism of Abrocitinib can be increased when combined with Adalimumab.
AcalabrutinibThe metabolism of Acalabrutinib can be increased when combined with Adalimumab.
Food Interactions
No interactions found.


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International/Other Brands
Amjevita (Amgen, Inc.) / Cyltezo (Boehringer Ingelheim Pharmaceuticals, Inc.) / Humira Pen (Abbott Laboratories)
Brand Name Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing EndRegionImage
AbriladaInjection, solution40 mg/0.8mLSubcutaneousPfizer Laboratories Div Pfizer Inc2023-12-142023-12-14US flag
AbriladaKit; Solution40 mg / 0.8 mLSubcutaneousPfizer Canada UlcNot applicableNot applicableCanada flag
AbriladaSolution40 mg / 0.8 mLSubcutaneousPfizer Canada Ulc2022-03-07Not applicableCanada flag
AbriladaSolution10 mg / 0.2 mLSubcutaneousPfizer Canada UlcNot applicableNot applicableCanada flag
AbriladaSolution40 mg / 0.8 mLSubcutaneousPfizer Canada Ulc2022-02-24Not applicableCanada flag
Mixture Products
NameIngredientsDosageRouteLabellerMarketing StartMarketing EndRegionImage
AbriladaAdalimumab (10 mg/0.2mL) + Isopropyl alcohol (70 mL/100mL)Injection, solution; KitSubcutaneous; TopicalPfizer Laboratories Div Pfizer Inc2023-10-182023-10-18US flag
AbriladaAdalimumab (10 mg/0.2mL) + Isopropyl alcohol (70 mL/100mL)Injection, solution; KitSubcutaneous; TopicalPfizer Laboratories Div Pfizer Inc2023-12-142023-12-14US flag
AbriladaAdalimumab (40 mg/0.8mL) + Isopropyl alcohol (70 mL/100mL)Injection, solution; KitSubcutaneous; TopicalPfizer Laboratories Div Pfizer Inc2023-10-18Not applicableUS flag
AbriladaAdalimumab (40 mg/0.8mL) + Isopropyl alcohol (70 mL/100mL)Injection, solution; KitSubcutaneous; TopicalPfizer Laboratories Div Pfizer Inc2023-12-14Not applicableUS flag
AbriladaAdalimumab (20 mg/0.4mL) + Isopropyl alcohol (70 mL/100mL)Injection, solution; KitSubcutaneous; TopicalPfizer Laboratories Div Pfizer Inc2023-10-18Not applicableUS flag


ATC Codes
L04AB04 — Adalimumab
Drug Categories
Chemical TaxonomyProvided by Classyfire
Not Available
Organic Compounds
Super Class
Organic Acids
Carboxylic Acids and Derivatives
Sub Class
Amino Acids, Peptides, and Analogues
Direct Parent
Alternative Parents
Not Available
Not Available
Molecular Framework
Not Available
External Descriptors
Not Available
Affected organisms
  • Humans and other mammals

Chemical Identifiers

CAS number


General References
  1. Kivitz A, Segurado OG: HUMIRA pen: a novel autoinjection device for subcutaneous injection of the fully human monoclonal antibody adalimumab. Expert Rev Med Devices. 2007 Mar;4(2):109-16. doi: 10.1586/17434440.4.2.109. [Article]
  2. Mease PJ: Adalimumab in the treatment of arthritis. Ther Clin Risk Manag. 2007 Mar;3(1):133-48. [Article]
  3. Scheinfeld N: Adalimumab (HUMIRA): a review. J Drugs Dermatol. 2003 Aug;2(4):375-7. [Article]
  4. Scheinfeld N: Adalimumab: a review of side effects. Expert Opin Drug Saf. 2005 Jul;4(4):637-41. doi: 10.1517/14740338.4.4.637. [Article]
  5. Fonder MA, Cummins DL, Ehst BD, Anhalt GJ, Meyerle JH: Adalimumab therapy for recalcitrant pyoderma gangrenosum. J Burns Wounds. 2006 Nov 20;5:e8. [Article]
  6. Hinterberger L, Muller CS, Vogt T, Pfohler C: Adalimumab: a treatment option for pyoderma gangrenosum after failure of systemic standard therapies. Dermatol Ther (Heidelb). 2012 Dec;2(1):6. doi: 10.1007/s13555-012-0006-6. Epub 2012 May 12. [Article]
  7. Ryman JT, Meibohm B: Pharmacokinetics of Monoclonal Antibodies. CPT Pharmacometrics Syst Pharmacol. 2017 Sep;6(9):576-588. doi: 10.1002/psp4.12224. Epub 2017 Jul 29. [Article]
  8. Farrugia M, Baron B: The role of TNF-alpha in rheumatoid arthritis: a focus on regulatory T cells. J Clin Transl Res. 2016 Sep 15;2(3):84-90. eCollection 2016 Nov 10. [Article]
  9. Matsuno H, Yudoh K, Katayama R, Nakazawa F, Uzuki M, Sawai T, Yonezawa T, Saeki Y, Panayi GS, Pitzalis C, Kimura T: The role of TNF-alpha in the pathogenesis of inflammation and joint destruction in rheumatoid arthritis (RA): a study using a human RA/SCID mouse chimera. Rheumatology (Oxford). 2002 Mar;41(3):329-37. doi: 10.1093/rheumatology/41.3.329. [Article]
  10. Bullock J, Rizvi SAA, Saleh AM, Ahmed SS, Do DP, Ansari RA, Ahmed J: Rheumatoid Arthritis: A Brief Overview of the Treatment. Med Princ Pract. 2018;27(6):501-507. doi: 10.1159/000493390. Epub 2018 Sep 2. [Article]
  11. Patent: Methods related to adalimumab [Link]
  12. Sandoz received US FDA approval for bio similar, Hyrimoz [Link]
  13. HUMIRA website [Link]
  14. Abbvie Website [Link]
  15. FDA Approved Drug Products: HUMIRA (adalimumab) injection [Link]
  16. FDA Approved Drug Products: HUMIRA (adalimumab) injection 2022 [Link]
  17. FDA Approved Drug Products: HULIO (adalimumab-fkjp) injection, for subcutaneous use [Link]
  18. FDA Approved Drug Products: HADLIMA (adalimumab-bwwd) injection, for subcutaneous use [Link]
  19. FDA Approved Drug Products: AMJEVITA (adalimumab-atto) injection, for subcutaneous use (November 2022) [Link]
  20. FDA Approved Drug Products: HYRIMOZ (adalimumab-adaz) injection, for subcutaneous use [Link]
  21. EMA Approved Drug Products: Hyrimoz (adalimumab) Subcutaneous Injection [Link]
  22. FDA Approved Drug Products: YUFLYMA (adalimumab-aaty) injection, for subcutaneous use [Link]
  23. FDA Approved Drug Products: HADLIMA (adalimumab-bwwd) injection, for subcutaneous use (June 2023) [Link]
  24. FDA Approved Drug Products: CYLTEZO® (adalimumab-adbm) injection, for subcutaneous use (July 2023) [Link]
  25. FDA Approved Drug Products: AMJEVITA (adalimumab-atto) injection, for subcutaneous use (July 2023) [Link]
  26. FDA Approved Drug Products: HADLIMA (adalimumab-bwwd) injection, for subcutaneous use (July 2023) [Link]
  27. FDA Approved Drug Products: HULIO (adalimumab-fkjp) injection, for subcutaneous use (September 2023) [Link]
  28. FDA Approved Drug Products: HYRIMOZ (adalimumab-adaz) injection, for subcutaneous use (September 2023) [Link]
  29. FDA Approved Drug Products: ABRILADA(adalimumab-afzb) injection, for subcutaneous use (October2023) [Link]
  30. FDA Approved Drug Products: HYRIMOZ (adalimumab-aaty) injection, for subcutaneous use (October2023) [Link]
  31. FDA Approved Drug Products: IDACIO (adalimumab-aacf) injection, for subcutaneous use (October 2023) [Link]
PubChem Substance
Therapeutic Targets Database
RxList Drug Page Drug Page

Clinical Trials

Clinical Trials
4Active Not RecruitingTreatmentAnkylosing Spondylitis (AS)1
4Active Not RecruitingTreatmentAxial Spondyloarthritis (AxSpA)1
4Active Not RecruitingTreatmentCD1
4Active Not RecruitingTreatmentJIA / Uveitis1
4Active Not RecruitingTreatmentJuvenile Idiopathic Arthritis Associated Uveitis1


Not Available
  • Abbott Laboratories Ltd.
  • Vetter Pharma Fertigung GmbH and Co. KG
Dosage Forms
Kit; solutionSubcutaneous40 mg / 0.8 mL
SolutionSubcutaneous10 mg / 0.2 mL
Injection, solution20 mg/0.4ml
Injection, solutionParenteral; Subcutaneous20 MG
Injection, solutionParenteral; Subcutaneous40 MG
SolutionSubcutaneous40.00 mg
SolutionSubcutaneous50 mg / mL
Injection, solutionParenteral40 MG
Injection, solution
Injection, solutionSubcutaneous
Injection, solutionParenteral40 MG/0.8ML
Injection, solutionSubcutaneous20 mg/0.4ml
SolutionSubcutaneous50 mg
InjectionSubcutaneous10 mg/0.2mL
InjectionSubcutaneous20 mg/0.2mL
InjectionSubcutaneous20 mg/0.4mL
InjectionSubcutaneous80 mg/0.8mL
SolutionSubcutaneous40 mg/0.8ml
SolutionSubcutaneous40 mg/0.4mL
Injection, solutionSubcutaneous20 MG
Injection, solutionSubcutaneous40 MG
Injection, solutionSubcutaneous80 mg
Injection, solutionSubcutaneous50 mg/ml
SolutionSubcutaneous20 mg / 0.4 mL
InjectionSubcutaneous40 MG/0.4ML
Injection, solutionParenteral; Subcutaneous80 MG
Injection, solution; kitSubcutaneous; Topical
Injection, solution; kit; swabSubcutaneous; Topical
Injection, suspension; kitSubcutaneous; Topical
SolutionSubcutaneous10 mg / 0.1 mL
SolutionSubcutaneous20 mg / 0.2 mL
SolutionSubcutaneous40 mg / 0.8 mL
SolutionSubcutaneous40 mg / 0.4 mL
SolutionSubcutaneous80 mg / 0.8 mL
SolutionSubcutaneous80.000 mg
Injection, solution20 mg/0.2ml
Injection, solutionParenteral40 MG/0.4ML
Injection, solution40 mg/0.4ml
Injection, solutionParenteral80 MG/0.8ML
Injection, solutionSubcutaneous20.0 mg/0.2mL
Injection, solutionSubcutaneous40.0 mg
Injection, solutionSubcutaneous40 mg/0.4ml
InjectionSubcutaneous40 mg
InjectionSubcutaneous40 mg/0.8ml
InjectionSubcutaneous40.0 mg
Injection, solutionSubcutaneous80.0 mg/0.8mL
Injection, solutionSubcutaneous20 mg/0.2ml
Injection, solutionSubcutaneous80 mg/0.8ml
SolutionSubcutaneous40 mg
SolutionSubcutaneous100 mg
Injection, solutionSubcutaneous10 mg/0.1mL
Injection, solution; kitSubcutaneous
SolutionSubcutaneous40.000 mg
Injection, solutionParenteral; Subcutaneous40 MG/0.8ML
Injection, solutionSubcutaneous40 mg/0.8mL
Injection, solutionIntravenous40 mg/0.8mL
Injection; kitSubcutaneous
Injection, solution40 mg/0.8ml
Unit descriptionCostUnit
Humira (1 Box = Two 40 mg/0.8ml Syringes) Box1995.1USD box
Humira 2 20 mg/0.4ml Kit 1 Box = Two 20 mg/0.4ml Syringes1995.1USD box
Humira Pen 2 40 mg/0.8ml Kit (1 Box = 1 Kit Containing Two 40 mg/0.8ml Pens)1995.1USD box
Humira 20 mg/0.4 ml syringe959.19USD syringe
Humira 40 mg/0.8 ml pen959.19USD pen
Humira crohn's starter pack959.19USD each
Humira psoriasis starter pack959.19USD each
DrugBank does not sell nor buy drugs. Pricing information is supplied for informational purposes only.
Patent NumberPediatric ExtensionApprovedExpires (estimated)Region
CA2243459No2002-09-172017-02-10Canada flag


Experimental Properties
isoelectric point8.25


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Pharmacological action
General Function
Tumor necrosis factor receptor binding
Specific Function
Cytokine that binds to TNFRSF1A/TNFR1 and TNFRSF1B/TNFBR. It is mainly secreted by macrophages and can induce cell death of certain tumor cell lines. It is potent pyrogen causing fever by direct ac...
Gene Name
Uniprot ID
Uniprot Name
Tumor necrosis factor
Molecular Weight
25644.15 Da
  1. Lorenz HM: Technology evaluation: adalimumab, Abbott laboratories. Curr Opin Mol Ther. 2002 Apr;4(2):185-90. [Article]
  2. Flendrie M, Creemers MC, Welsing PM, den Broeder AA, van Riel PL: Survival during treatment with tumour necrosis factor blocking agents in rheumatoid arthritis. Ann Rheum Dis. 2003 Nov;62 Suppl 2:ii30-3. [Article]
  3. Aguillon JC, Contreras J, Dotte A, Cruzat A, Catalan D, Salazar L, Molina MC, Guerrero J, Lopez M, Soto L, Salazar-Onfray F, Cuchacovich M: [New immunological weapons for medicine in the 21st Century: biological therapy based on the use of the latest generation monoclonal antibodies]. Rev Med Chil. 2003 Dec;131(12):1445-53. [Article]
  4. Bang LM, Keating GM: Adalimumab: a review of its use in rheumatoid arthritis. BioDrugs. 2004;18(2):121-39. [Article]
  5. Matusiak L, Jemec GB, Szepietowski JC: Pharmacological development in hidradenitis suppurativa. Curr Opin Pharmacol. 2019 Jun;46:65-72. doi: 10.1016/j.coph.2019.04.006. Epub 2019 May 7. [Article]

Drug created at June 13, 2005 13:24 / Updated at April 09, 2024 18:10