HUMIRA (adalimumab)
HUMIRA is indicated for the treatment of Rheumatoid Arthritis; Psoriatic Arthritis; Ankylosing Spondylitis; Crohn Disease; Ulcerative Colitis; Plaque Psoriasis; Hidradenitis Suppurativa; Uveitis; Juvenile Idiopathic Arthritis.
How HUMIRA Works
Adalimumab binds specifically to TNF-alpha, a naturally occurring cytokine that plays a central role in inflammatory and immune responses. By blocking TNF-alpha from interacting with the p55 and p75 cell surface receptors, the drug reduces the pathological inflammation and joint destruction associated with elevated TNF levels. Additionally, the drug modulates biological responses regulated by TNF, such as the concentration of adhesion molecules responsible for leukocyte migration, and can lyse cells that express surface TNF.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2002-12-31
- Patent Cliff
- 2023
- Revenue
- $688M (Q1-2026)
- Routes
- N/A
- Dosage Forms
- VIAL, SYRINGE
HUMIRA Approval History
What HUMIRA Treats
9 indicationsHUMIRA is approved for 9 conditions since its original approval in 2002. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Rheumatoid Arthritis
- Psoriatic Arthritis
- Ankylosing Spondylitis
- Crohn Disease
- Ulcerative Colitis
- Plaque Psoriasis
- Hidradenitis Suppurativa
- Uveitis
HUMIRA Boxed Warning
SERIOUS INFECTIONS AND MALIGNANCY SERIOUS INFECTIONS Patients treated with HUMIRA are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions ( 5.1 )]. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Discontinue HUMIRA if a patient develops a serious infection or sepsis. Reported infections include: Active tuberculosis (TB), including reactivation o...
WARNING: SERIOUS INFECTIONS AND MALIGNANCY SERIOUS INFECTIONS Patients treated with HUMIRA are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions ( 5.1 )]. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Discontinue HUMIRA if a patient develops a serious infection or sepsis. Reported infections include: Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before HUMIRA use and during therapy. Initiate treatment for latent TB prior to HUMIRA use. Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric anti-fungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness. Bacterial, viral and other infections due to opportunistic pathogens, including Legionella and Listeria. Carefully consider the risks and benefits of treatment with HUMIRA prior to initiating therapy in patients with chronic or recurrent infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with HUMIRA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy [see Warnings and Precautions ( 5.1 ) and Adverse Reactions ( 6.1 )]. MALIGNANCY Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers including HUMIRA [see Warnings and Precautions ( 5.2 )]. Post-marketing cas
HUMIRA Target & Pathway
ProTarget
A pro-inflammatory cytokine that plays a central role in immune responses and inflammation. Excess TNF contributes to autoimmune diseases like rheumatoid arthritis, psoriasis, and inflammatory bowel disease. Blocking TNF reduces inflammation and prevents tissue damage.
HUMIRA Biosimilars
10 FDA-approved8 can be substituted at the pharmacy without calling the prescriber. The other 2 require prescriber approval to switch.
What are biosimilars? Lower-cost alternatives to HUMIRA with no clinically meaningful differences.
Auto-substitute OK = FDA "interchangeable" designation — pharmacist can switch without calling the doctor.
HUMIRA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in HUMIRA's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications HUMIRA treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to HUMIRA
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
208 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06100744 | M23-732 2023-506026-36-00 | Ph 3 | recruiting | A Study to Assess Adverse Events, Change in Disease Activity, and How the Drug Moves Through the Body in Children With Juvenile Psoriatic Arthritis (jPsA) Receiving Subcutaneously Injected Risankizumab or Adalimumab |
| NCT07151937 | M-27134-10 2025-521293-34-00 | Ph 2 | recruiting | A Study of LAD191 in Adults With Hidradenitis Suppurativa |
| NCT07061574 WAVE T1D | 24745 | Ph 1, Ph 2 | recruiting | A Randomized Phase 1/2 Trial of Low Dose Anti-thymocyte Globulin (ATG) With Subsequent Adalimumab or Verapamil in New Onset Type 1 Diabetes |
| NCT06180382 VEDIAN | 23CH134 2023-508154-25-00 | Ph 4 | recruiting | Comparison of Vedolizumab Treatment to Adalimumab Dose Intensification in Crohn's Disease Patients With Loss of Response or Biomarker Activity to Adalimumab on First Line With Therapeutic Drug Concentration. |
| NCT04088409 results posted | 16277 I4V-MC-JAHW, 2019-000119-10 | Ph 3 | active not recruiting | A Study of Baricitinib (LY3009104) in Participants From 2 Years to Less Than 18 Years Old With Active JIA-Associated Uveitis or Chronic Anterior Antinuclear Antibody-Positive Uveitis |
| NCT03412747 BE SURE results posted | PS0008 2016-003392-22 | Ph 3 | completed | A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis |
| NCT06996652 PRISMS | 2000038476 2000038206, YPD-001 | Ph 2 | not yet recruiting | 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) |
| NCT02113904 AntiTNF-SN | P100150 2013-002205-54 | Ph 2 | completed | Clinical Trial Using Humira in Netherton Syndrome |
| NCT01895764 COMARIS | PHRI12-ED-COMARIS 2012-004939-23, A130042-32 | Ph 4 | completed | Effect of the Combination of Methotrexate and Adalimumab on Reduction of Immunization in Ankylosing Spondylitis (COMARIS) |
| NCT02840175 AJIBIOREM | P 150902 2016-000312-15 | Ph 3 | completed | Treatment Tapering in JIA With Inactive Disease |
| NCT04527380 results posted | 16694 I1F-MC-RHCG, 2018-000681-10 | Ph 3 | active not recruiting | A Study of Ixekizumab (LY2439821) in Children With Juvenile Idiopathic Arthritis Categories of Enthesitis-related Arthritis (Including Juvenile Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis |
| NCT06045754 | Vedolizumab-4051 MACS-2022-120102, EXPLORER 2.0 | Ph 4 | recruiting | A Study of Vedolizumab Intravenous (IV) and Adalimumab or Vedolizumab and Ustekinumab in Adults With Crohn's Disease |
| NCT06037811 | CanRIO ADA2023 | Ph 2 | recruiting | Early Adalimumab Induction for Immune Checkpoint Inhibitor Associated Inflammatory Arthritis |
| NCT06941376 PROSECT RP | VCRC5565 | Ph 2 | recruiting | An Open-Label Study of Effectiveness of Immunomodulatory Medications for Patients With Relapsing Polychondritis |
| NCT03895203 BE OPTIMAL results posted | PA0010 2017-002322-20 | Ph 3 | completed | A Study to Test the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis |
| NCT07352566 | 25-43621 | Ph 4 | not yet recruiting | Utilization of a Microdevice for Psoriasis and Atopic Dermatitis |
| NCT02586831 DIPIT | 20150856 | Ph 1, Ph 2 | withdrawn | Diabetes Islet Preservation Immune Treatment |
| NCT05814627 SELECT- SWITCH | M23-700 2022-502578-18-00 | Ph 3 | active not recruiting | Study to Assess Change in Disease Activity and Adverse Events of Oral Upadacitinib Compared to Subcutaneous Adalimumab in Adult Participants With Moderate to Severe Rheumatoid Arthritis |
| NCT01382160 AFORA | PHRI10-DM/AFORA 2010-021449-28, A100898-30 | Ph 4 | completed | Serum Concentration of Adalimumab as a Predictive Factor of Clinical Outcomes in Rheumatoid Arthritis (AFORA) |
| NCT07268534 BOOSTERS | APHP230831 2024-514848-88-00 | Ph 2 | not yet recruiting | Biologics in Folliculitis Decalvans : an Adaptative Trial Research |
| NCT03739853 SPEED results posted | 18/SC/0107 | Ph 4 | completed | Severe Psoriatic Arthritis - Early intervEntion to Control Disease: the SPEED Trial |
| NCT03651518 PIMOC | P160906J 2017-000519-18 | Ph 2 | completed | Personalized Therapies in Inflammatory Complex Disease |
| NCT05535738 | STUDY00000321 | Ph 2, Ph 3 | active not recruiting | Using a Contact Dermatitis Model With Biologic Medications to Study Skin Inflammation |
| NCT02632175 results posted | M10-870 2015-001346-29 | Ph 3 | completed | Long-term Safety and Efficacy Study of Adalimumab in Pediatric Subjects With Ulcerative Colitis |
| NCT06257875 | M23-703 2023-505678-14-00 | Ph 2 | active not recruiting | 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 |
| NCT03104400 SELECT - PsA 1 results posted | M15-572 2016-004130-24 | Ph 3 | completed | A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Participants With Psoriatic Arthritis Who Have an Inadequate Response to at Least One Non-Biologic Disease Modifying Anti-Rheumatic Drug (DMARD) |
| NCT02929251 RUBI | P150945 2016-002284-34 | Ph 2 | completed | Randomized Trial Comparing Efficacy of Adalimumab, Anakinra and Tocilizumab in Non-infectious Refractory Uveitis |
| NCT07138898 | 25-00380 | Ph 2 | not yet recruiting | Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty |
| NCT03316781 | HLX03-Ps03 | Ph 3 | completed | Study of Efficacy and Safety of HLX03 in Subjects With Moderate to Severe Plaque Psoriasis |
| NCT02629159 SELECT-COMPARE results posted | M14-465 2022-501017-31-00 | Ph 3 | active not recruiting | A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Adults With Rheumatoid Arthritis Who Are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate |
| NCT06640517 PLANETA-KIDS | BCD-085-16 | Ph 3 | active not recruiting | Study of the Efficacy, Safety, Pharmacokinetics, and Immunogenicity of Netakimab in Children With Moderate to Severe Plaque Psoriasis |
| NCT07013838 | TYK2-TAK-01 | Ph 4 | not yet recruiting | The Efficacy and Safety of Deucravacitinib in Takayasu's Arteritis |
| NCT05414201 | M20-387 | Ph 4 | completed | A Study to Assess Change in Disease Activity and Adverse Events of Adalimumab in Chinese Participants Requiring High Dose Corticosteroids for Active Non-Infectious Intermediate, Posterior, or Pan-Uveitis |
| NCT03816397 ADJUST results posted | 17-23987 UG1EY029658 | Ph 4 | completed | Adalimumab in JIA-associated Uveitis Stopping Trial |
| NCT04655807 DUET | CR108898 2020-002701-26, 64304500CRD2002 | Ph 2 | withdrawn | A Study of JNJ-64304500 as Add-on Therapy in Participants With Active Crohn's Disease |
| NCT05884242 | CR109299 2022-002896-13, NOPRODPBNAP1001 | Ph 1 | completed | A Study of Adalimumab on Inflammatory Mediators Following a Systemic Endotoxin Challenge |
| NCT03505008 results posted | D2E7-C000-401 | Ph 4 | completed | Evaluation of the Optimal MTX Dose as an Add-on Therapy to Adalimumab for RA Patients in Japan, South Korea and Taiwan |
| NCT06849908 | Baricitinib-IBS-PUMCH | Ph 2 | recruiting | Baricitinib in the Treatment of Intestinal Behçet's Syndrome |
| NCT02706704 IVAS | OPH.RH.07 | Ph 2 | recruiting | Intravitreal Adalimumab Versus Subcutaneous Adalimumab in Non-infectious Uveitis |
| NCT04909801 results posted | IM101-863 2020-000350-96, U1111-1247-1367 | Ph 3 | active not recruiting | A Study to Compare the Response to Treatment With Abatacept vs Adalimumab, on Background Methotrexate, in Adults With Early, Seropositive, and Shared Epitope-positive Rheumatoid Arthritis and an Inadequate Response to Methotrexate |
| NCT06833112 | 2024114K | Ph 4 | not yet recruiting | Interleukin-17 (IL-17) Inhibitor in Combination With Tumor Necrosis Factor α (TNFα )Inhibitor for the Treatment of Ankylosing Spondylitis |
| NCT02852694 RCT | 2016-01 | Ph 4 | completed | Reduce Risk for Crohn's Disease Patients |
| NCT04646187 FREE | 202000261 2020-001811-26 | Ph 4 | enrolling by invitation | De-escalation of Anti-TNF Therapy in Inflammatory Bowel Disease |
| NCT06062875 | EH22-232 R01DK135516 | Ph 2 | recruiting | Effects of TNF Blockade on Human BPH/LUTS |
| NCT03737708 | 506-MA-3187 | Ph 4 | completed | A Study Comparing Biologics + Methotrexate With Biologics + Tacrolimus in Patients With Rheumatoid Arthritis (RA) |
| NCT04009668 results posted | HUM00147018 | Ph 2 | completed | Tumor Necrosis Factor Inhibition in Focal Segmental Glomerulosclerosis and Treatment Resistant Minimal Change Disease |
| NCT06498089 | B2024-200R | Ph 4 | recruiting | 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 |
| NCT05640245 | M1095-PSA-201 | Ph 2 | completed | Evaluation of Sonelokimab for the Treatment of Patients With Active Psoriatic Arthritis |
| NCT06527534 FILRA | 215CET - FILRA | Ph 4 | recruiting | Filgotinib Effect on Proteomic Profile and Micro-RNA Expression in Patients With Active Rheumatoid Arthritis (RA) |
| NCT02451748 results posted | 2015-0117 | Ph 4 | completed | IL-7 and IL-7R Expression in RA Patients With Active vs. Inactive Disease Treated With DMARD or CIMZIA |
Showing 50 of 208 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
HUMIRA FDA Label Details
Indications & Usage
FDA Label (PDF)HUMIRA is indicated for the treatment of Rheumatoid Arthritis; Psoriatic Arthritis; Ankylosing Spondylitis; Crohn Disease; Ulcerative Colitis; Plaque Psoriasis; Hidradenitis Suppurativa; Uveitis; Juvenile Idiopathic Arthritis.
WARNING: SERIOUS INFECTIONS AND MALIGNANCY SERIOUS INFECTIONS Patients treated with HUMIRA are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions ( 5.1 )]. Most patients who developed these infections were taking concomitant im...
Pro Intelligence Preview
Deep insights for HUMIRA
Revenue Insights
- • Q1-2026: $688M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2023
- • Generic/biosimilar risk
Trial Analysis
- • 220 total trials
- • Stage: Declining
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Related Intelligence
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment