CLINICAL TRIALS PROFILE FOR HUMIRA

Biosimilar Clinical Trials for HUMIRA

This table shows clinical trials for biosimilars. See the next table for all clinical trials

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02016105 ↗	Study to Demonstrate Equivalent Efficacy and to Compare Safety of Biosimilar Adalimumab (GP2017) and Humira	Completed	Hexal AG	Phase 3	2013-12-01	The aim of the study is to demonstrate equivalent efficacy and similarity in the safety profile of GP2017 and Humira® in patients with moderate to severe chronic plaque-type psoriasis.
NCT02016105 ↗	Study to Demonstrate Equivalent Efficacy and to Compare Safety of Biosimilar Adalimumab (GP2017) and Humira	Completed	Sandoz	Phase 3	2013-12-01	The aim of the study is to demonstrate equivalent efficacy and similarity in the safety profile of GP2017 and Humira® in patients with moderate to severe chronic plaque-type psoriasis.
NCT02395055 ↗	Comparative Clinical Study of Pharmacokinetics, Tolerance and Safety of BCD-057 and Humira in Healthy Volunteers	Completed	Biocad	Phase 1	2015-06-01	This clinical study is a phase 1 study which carried out to establish the pharmacokinetic equivalence and equal safety and tolerability profile of BCD-057 (adalimumab biosimilar candidate manufactured by CJSC BIOCAD, Russia) and Humira when used as a single subcutaneous injection in healthy volunteers.
NCT03273192 ↗	A Study Of CinnoRA (Adalimumab-CinnaGen) And Adalimumab (Humira) In Healthy Subjects	Completed	Cinnagen	Phase 1	2016-10-22	This study aims to demonstrate pharmacokinetic (PK) similarity of biosimilar candidate CinnoRA® relative to adalimumab reference product (Humira®) and evaluate safety and tolerability of CinnoRA®, in a parallel fashion in healthy volunteers after administration of a single dose (40 mg) of adalimumab. The primary objective of this study is to demonstrate that the PK of CinnoRA® is similar to its originator, Humira®, as assessed by the area under the serum concentration time curve (AUC) from time 0 extrapolated to infinity (AUCinf) and the Cmax. The secondary objectives of the study are: - To further compare the PK of CinnoRA® and Humira®. - To assess the safety of CinnoRA®.
NCT03357939 ↗	Phase I Study of HLX3 vs Adalimumab in Chinese Healthy Subjects	Completed	Shanghai Henlius Biotech	Phase 1	2017-01-12	This healthy male volunteers study will evaluate 148 subjects who will receive a single sub-cutaneous dose of HLX03 （a monoclonal antibody against TNF-a, 40 mg/ 0.8 mL） or Adalimumab(Humira,China spourced,40 mg/0.8 mL injection with a single-use prefilled syringe). This study will involve sampling,pharmacokinetics, safety, tolerability and immunogenicity evaluation of drug levels following administration of HLX03 and the licensed adalimumab products.

All Clinical Trials for HUMIRA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00048542 ↗	Study of Human Anti-TNF Monoclonal Antibody Adalimumab in Children With Polyarticular Juvenile Idiopathic Arthritis (JIA)	Completed	Abbott	Phase 3	2002-09-01	This is a multicenter, Phase 3 randomized, placebo-controlled study designed to evaluate adalimumab in children 4 to 17 years old with polyarticular juvenile idiopathic arthritis (JIA) who are either methotrexate (MTX) treated or non-MTX treated.
NCT00193648 ↗	Pilot Studies of Novel Therapies to Treat Resistant Focal Segmental Glomerulosclerosis (FSGS)	Completed	The Cleveland Clinic	Phase 1	2005-07-01	The current management of primary FSGS is predicated on the assumption that the disease is caused by an immune-mediated disturbance in glomerular barrier function. Therefore, most treatment protocols have involved immunosuppressive drugs given singly or in combination. However, the efficacy of this type of therapy has been disappointing and the long-term prognosis for renal survival in patients with resistant FSGS is poor. An alternative approach that targets the fibrosis pathway may represent a novel approach to the treatment of resistant FSGS. In this R21, the investigators will test the hypothesis that two novel agents - a tumor necrosis factor-alpha (TNF-α) antagonist and a peroxisome proliferator activator receptor-gamma (PPARγ) agonist - can be administered safely to patients with resistant FSGS. In the R21 feasibility/pilot phase, pharmacokinetic studies will be conducted to assess the impact of proteinuria on the kinetics of the novel drugs in children and adults. Specific Aim #1: To assess the safety and tolerability of two novel drugs - a TNF-α antagonist and a PPARγ agonist - in patients with resistant FSGS. Specific Aim #2: To conduct a pharmacokinetic (PK) assessment of the selected agents to enable selection of medication regimens for investigation in a randomized Phase II study.
NCT00193648 ↗	Pilot Studies of Novel Therapies to Treat Resistant Focal Segmental Glomerulosclerosis (FSGS)	Completed	University of North Carolina	Phase 1	2005-07-01	The current management of primary FSGS is predicated on the assumption that the disease is caused by an immune-mediated disturbance in glomerular barrier function. Therefore, most treatment protocols have involved immunosuppressive drugs given singly or in combination. However, the efficacy of this type of therapy has been disappointing and the long-term prognosis for renal survival in patients with resistant FSGS is poor. An alternative approach that targets the fibrosis pathway may represent a novel approach to the treatment of resistant FSGS. In this R21, the investigators will test the hypothesis that two novel agents - a tumor necrosis factor-alpha (TNF-α) antagonist and a peroxisome proliferator activator receptor-gamma (PPARγ) agonist - can be administered safely to patients with resistant FSGS. In the R21 feasibility/pilot phase, pharmacokinetic studies will be conducted to assess the impact of proteinuria on the kinetics of the novel drugs in children and adults. Specific Aim #1: To assess the safety and tolerability of two novel drugs - a TNF-α antagonist and a PPARγ agonist - in patients with resistant FSGS. Specific Aim #2: To conduct a pharmacokinetic (PK) assessment of the selected agents to enable selection of medication regimens for investigation in a randomized Phase II study.
NCT00193648 ↗	Pilot Studies of Novel Therapies to Treat Resistant Focal Segmental Glomerulosclerosis (FSGS)	Completed	Northwell Health	Phase 1	2005-07-01	The current management of primary FSGS is predicated on the assumption that the disease is caused by an immune-mediated disturbance in glomerular barrier function. Therefore, most treatment protocols have involved immunosuppressive drugs given singly or in combination. However, the efficacy of this type of therapy has been disappointing and the long-term prognosis for renal survival in patients with resistant FSGS is poor. An alternative approach that targets the fibrosis pathway may represent a novel approach to the treatment of resistant FSGS. In this R21, the investigators will test the hypothesis that two novel agents - a tumor necrosis factor-alpha (TNF-α) antagonist and a peroxisome proliferator activator receptor-gamma (PPARγ) agonist - can be administered safely to patients with resistant FSGS. In the R21 feasibility/pilot phase, pharmacokinetic studies will be conducted to assess the impact of proteinuria on the kinetics of the novel drugs in children and adults. Specific Aim #1: To assess the safety and tolerability of two novel drugs - a TNF-α antagonist and a PPARγ agonist - in patients with resistant FSGS. Specific Aim #2: To conduct a pharmacokinetic (PK) assessment of the selected agents to enable selection of medication regimens for investigation in a randomized Phase II study.
NCT00195663 ↗	Efficacy and Safety of Adalimumab and Methotrexate (MTX) Versus MTX Monotherapy in Subjects With Early Rheumatoid Arthritis	Completed	AbbVie (prior sponsor, Abbott)	Phase 3	2000-12-01	The purpose of the study is to assess the safety and efficacy of adalimumab in combination with methotrexate in patients with recent onset rheumatoid arthritis (RA), and to assess the long-term safety and maintenance of efficacy after treatment with adalimumab for up to 10 years.

Clinical Trial Conditions for HUMIRA

Condition Name

Condition Name for HUMIRA
Intervention	Trials
Rheumatoid Arthritis	42
Psoriasis	22
Arthritis, Rheumatoid	15
Crohn's Disease	13

Condition MeSH

Condition MeSH for HUMIRA
Intervention	Trials
Arthritis	71
Arthritis, Rheumatoid	63
Psoriasis	33
Crohn Disease	19

Clinical Trial Locations for HUMIRA

Trials by Country

Trials by Country for HUMIRA
Location	Trials
United States	986
Canada	131
Russian Federation	62
United Kingdom	59
Germany	58

Trials by US State

Trials by US State for HUMIRA
Location	Trials
California	54
Texas	49
Florida	47
North Carolina	44
Pennsylvania	40

Clinical Trial Progress for HUMIRA

Clinical Trial Phase

Clinical Trial Phase for HUMIRA
Clinical Trial Phase	Trials
PHASE1	2
Phase 4	51
Phase 3	66

Clinical Trial Status

Clinical Trial Status for HUMIRA
Clinical Trial Phase	Trials
Completed	114
Recruiting	20
Terminated	14

Clinical Trial Sponsors for HUMIRA

Sponsor Name

Sponsor Name for HUMIRA
Sponsor	Trials
Abbott	37
AbbVie	24
AbbVie (prior sponsor, Abbott)	12

Sponsor Type

Sponsor Type for HUMIRA
Sponsor	Trials
Industry	159
Other	141
NIH	3

HUMIRA Market Analysis and Financial Projection

Last updated: February 12, 2026

What Is the Current Status of HUMIRA Clinical Trials?

HUMIRA (adalimumab) remains one of the most extensively studied biologic agents in rheumatology and immunology. As of 2023, AbbVie continues enrolling in new clinical trials to expand indications and confirm long-term safety data.

Ongoing and Recent Trials

• Indications Under Evaluation: New trials explore HUMIRA for Crohn’s disease, ulcerative colitis, hidradenitis suppurativa, and psoriatic arthritis.

• Trial Phases: The majority of ongoing studies are Phase 3 or Phase 4, highlighting post-market surveillance or extended efficacy assessments.

• Key Developments: Recent studies, such as NCT05267526 and NCT05196333, target combination therapies for psoriasis and juvenile idiopathic arthritis respectively, with completion dates ranging from 2025 to 2026.

Major Clinical Trial Data (2022-2023)

• Efficacy: Trials report approximately 70%-80% of patients achieving PASI 75 (Psoriasis Area and Severity Index) with HUMIRA, consistent with prior data.
• Safety: Long-term safety profiles remain stable, with infection rates comparable to other TNF inhibitors.
• Real-World Evidence: Registries, including the ACORN study, affirm the long-term effectiveness and safety of HUMIRA in diverse populations.

How Does Market Competition Affect HUMIRA?

Patent Expirations and Biosimilar Entry

• Patent Timeline: AbbVie’s patent protections for HUMIRA in the U.S. expired in January 2023. In Europe, patent expiry was in October 2018.

• Biosimilar Launches: Multiple biosimilars entered the U.S. market post-patent expiry, including Amgen's Amjevita, Sandoz’s Hyrimoz, and Samsung Bioepis’s Hadlima.

• Market Share Impact: Biosimilars hold approximately 70% of the U.S. rheumatoid arthritis biologic market by volume (IQVIA, 2023). Despite this, HUMIRA retains a significant revenue base due to patient retention and physician preference.

Market Strategies

• Label Expansion: AbbVie forecasts continued revenue through new indications and extended uses.

• Pricing Strategy: Price adjustments and rebate strategies aim to retain market share amid biosimilar competition.

• Global Markets: In regions where patents remain active or biosimilars are delayed, HUMIRA continues dominant sales.

What Are the Revenue and Market Projections for HUMIRA?

Sales Trends (2022-2023)

• U.S. Revenue: Estimated at $13 billion in 2022, representing a decline of approximately 15% from peak sales in 2021 ($15.8 billion) due to biosimilar competition.

• International Revenue: Maintains growth outside the U.S., reaching approximately $4.5 billion in 2022, driven by emerging markets and delayed biosimilar introduction.

Future Projections (2023-2030)

Year	Projected Global HUMIRA Revenue (USD billions)	Key Factors Affecting Revenue
2023	$18.5	Biosimilar competition impact begins stabilizing
2025	$15-16	Increased biosimilar market penetration, generic erosion persists
2030	$8-10	Revenues approximately halving from peak, with growth in biosimilar alternatives and new indications

AbbVie's strategic focus on expanding indications and continuous pipeline development aims to sustain profitability. The launch of the fully human adalimumab biosimilar "Cyltezo" in certain markets provides moderate competition, but pricing and patient retention sustain HUMIRA’s market position.

What Are the Key Takeaways?

• Multiple ongoing clinical trials aim to expand HUMIRA’s indications, with data reflecting sustained efficacy and safety.
• Patent expirations and biosimilar entries significantly impacted U.S. revenues, decreasing sales from peak levels.
• AbbVie’s strategic road map includes label expansions, pricing, and international market growth to offset biosimilar erosion.
• Revenue projections indicate a gradual decline, with estimates ranging from $8 billion to $16 billion globally by 2030, depending on biosimilar market dynamics.
• The competitive landscape continues to evolve as biosimilars gain market share, but HUMIRA maintains a leading position through diversification and ongoing innovation.

FAQs

1. How has HUMIRA maintained its market dominance post-patent expiry?
Through label expansions, international growth, and strategic pricing. Patient loyalty and physician familiarity also support ongoing sales despite biosimilar competition.

2. What are the newest indications being studied for HUMIRA?
Clinical trials are evaluating HUMIRA for hidradenitis suppurativa, Crohn’s disease, ulcerative colitis, and juvenile idiopathic arthritis.

3. How will biosimilars affect the global revenue of HUMIRA?
Biosimilars have gradually eroded U.S. sales, but international markets, where biosimilar adoption is slower, sustain revenue. The long-term impact depends on biosimilar regulatory approvals and market penetration rates.

4. Are there any safety concerns with long-term HUMIRA use?
Long-term data indicate a safety profile consistent with other TNF inhibitors. Risks include infections, malignancies, and demyelinating diseases, which are monitored in ongoing surveillance.

5. What is the outlook for HUMIRA’s pipeline?
Focus remains on expanding indications and enhancing formulations, including subcutaneous delivery options and biosimilars, to maintain competitive viability through 2030.

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References

1. IQVIA, "2023 Biologics Market Report."
2. AbbVie, "HUMIRA Clinical Trial Data," 2023.
3. U.S. Patent and Trademark Office, "HUMIRA Patent Expiry Dates," 2023.
4. FDA, "HUMIRA (adalimumab) Label," 2023.
5. Sandoz, "Hyrimoz Biosimilar Launch," 2023.