CLINICAL TRIALS PROFILE FOR ADALIMUMAB

Biosimilar Clinical Trials for Adalimumab

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.
NCT03579823 ↗	Comparative Safety, Tolerability, Pharmacokinetic Study of AVT02 (100MG/ML) and Humira (100MG/ML) in Healthy Volunteers	Completed	Alvotech Swiss AG	Phase 1	2018-05-21	Adalimumab is an immunosuppressive drug that belongs to the family of anti-TNF agents. It contains a monoclonal antibody produced by biotechnology. It is designed to bind to tumor necrosis factor (TNF), a substance that is involved in several auto-immune processes. By binding to TNF, adalimumab blocks its activity, reducing the severity of various chronic inflammatory diseases including Rheumatoid Arthritis, Plaque Psoriasis and others. Often, the high cost of biologic products may preclude access to the treatment to a big portion of the population worldwide. A biosimilar product that provides comparable safety and efficacy at more affordable cost would fulfill a broader medical need. Humira has been available on the market for several years. Recently, a higher concentration (100 mg/mL) formulation has been introduced in major markets. Alvotech is developing AVT02, that is a proposed biosimilar of adalimumab containing high concentration (100 mg/mL) of active ingredient. The objective of this clinical trial is to assess the similarity of AVT02 (100 mg/mL) with Humira (100 mg/mL), in terms of tolerability, safety (including immunogenicity) and compare the pharmacokinetics in healthy volunteers.

All Clinical Trials for Adalimumab

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.
NCT00049751 ↗	Study of Human Anti-TNF Monoclonal Antibody D2E7 in Subjects With Active Rheumatoid Arthritis	Completed	Abbott	Phase 3	2002-09-01	The purpose of the study is to evaluate safety by collecting serious adverse events in subjects with moderately to severely active rheumatoid arthritis who are unable to obtain etanercept and who have failed one or more prior disease-modifying antirheumatic drugs (DMARDs).
NCT00055523 ↗	A Study of the Human Anti-TNF Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Crohn's Disease	Completed	Abbott	Phase 2	2002-04-01	Purpose of the study is to test whether adalimumab can induce clinical remission in subjects with active Crohn's disease when compared to placebo (an inactive substance)
NCT00077779 ↗	Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects With Crohn's Disease	Completed	Abbott	Phase 3	2003-07-01	The purpose of this study is to test whether Adalimumab (at two different doses) can induce and maintain clinical remission in subjects with active Crohn's disease when compared to placebo (a substance containing no medication)
NCT00105300 ↗	Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Crohn's Disease	Completed	Abbott	Phase 3	2004-10-01	The goal of this study is to test whether adalimumab can induce clinical remission in subjects with active Crohn's disease who have been initially treated with infliximab and either lost response or discontinued its use as a result of intolerance to the drug.
NCT00133315 ↗	TNFalfa Blocking Treatment of Spondylarthropathies	Completed	Hvidovre University Hospital	Phase 4	2004-09-01	The purpose of the study is to establish a Danish cohort of spondylarthropathy (SpA) patients who are being treated with TNFalfa blockers. By following the TNFalfa blocking treated patients the researchers want to identify better biomarkers for disease activity and disease progression. In addition, the researchers want to identify predictors for disease progression.

Clinical Trial Conditions for Adalimumab

Condition Name

Condition Name for Adalimumab
Intervention	Trials
Rheumatoid Arthritis	99
Psoriasis	36
Crohn's Disease	29
ULCERATIVE COLITIS	23

Condition MeSH

Condition MeSH for Adalimumab
Intervention	Trials
Arthritis	145
Arthritis, Rheumatoid	125
Psoriasis	57
Crohn Disease	53

Clinical Trial Locations for Adalimumab

Trials by Country

Trials by Country for Adalimumab
Location	Trials
Canada	234
United Kingdom	166
Spain	145
Germany	127
France	126

Trials by US State

Trials by US State for Adalimumab
Location	Trials
California	106
Florida	94
Texas	93
North Carolina	82
Pennsylvania	80

Clinical Trial Progress for Adalimumab

Clinical Trial Phase

Clinical Trial Phase for Adalimumab
Clinical Trial Phase	Trials
PHASE4	9
PHASE3	4
PHASE2	9

Clinical Trial Status

Clinical Trial Status for Adalimumab
Clinical Trial Phase	Trials
Completed	203
Recruiting	60
Not yet recruiting	34

Clinical Trial Sponsors for Adalimumab

Sponsor Name

Sponsor Name for Adalimumab
Sponsor	Trials
Abbott	60
AbbVie	35
AbbVie (prior sponsor, Abbott)	13

Sponsor Type

Sponsor Type for Adalimumab
Sponsor	Trials
Other	371
Industry	288
NIH	9

Adalimumab Clinical Trials Update, Market Analysis, and Projections (2026–2030)

Last updated: April 25, 2026

What is adalimumab’s current market position?

Adalimumab is the leading TNF-alpha monoclonal antibody by global sales among biologics for chronic inflammatory diseases. It is marketed as Humira (AbbVie) and also as biosimilars in multiple jurisdictions. The competitive base is increasingly defined by:

• Biosimilars with growing share in Europe and parts of Asia
• Switching dynamics from originator to biosimilars driven by payer policy and contracting
• Patent and exclusivity expiries by geography, plus manufacturer launch strategies

Global commercialization snapshot (originator and biosimilar pressure)

Key market structure points for decision-making:

• Originator exposure is declining as biosimilars penetrate established care pathways in rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), Crohn’s disease (CD), ulcerative colitis (UC), and juvenile idiopathic arthritis (JIA).
• Biosimilar competition is concentrated in large payer markets where tendering and formulary placement accelerate share transfer.
• Volume resilience depends on guideline adherence and persistence in chronic therapy, while pricing declines with biosimilar discounting.

(Sales figures and country-specific shares are not restated here because no source dataset was provided in the prompt.)

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What is the clinical trials update for adalimumab?

Adalimumab’s late-stage and ongoing clinical program is concentrated in:

• New patient populations and refined subtypes
• Route-of-administration optimization and dose/regimen simplification
• Head-to-head and real-world comparative evidence versus other biologics/biologics switching strategies
• Combination strategies with conventional immunomodulators where relevant

Trial activity themes seen across the adalimumab pipeline

The operational pattern in adalimumab development is less about first-in-class mechanism novelty and more about:

• Expansion across inflammatory disease phenotypes
• Evidence generation for treatment positioning after first-line failure
• Safety and effectiveness confirmation in routine practice cohorts

Where the program focus concentrates

Clinically, adalimumab remains anchored in major TNF-alpha use cases:

• RA and other spondyloarthritides (AS, PsA)
• IBD (CD, UC)
• Pediatric indications (JIA spectrum)

(Specific trial IDs, phases, endpoints, and timelines are not enumerated here because no clinical trial registry feed or named studies were included in the prompt.)

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What is the regulatory and exclusivity landscape impact?

The market outlook for adalimumab depends on geography-specific expiration timing and biosimilar regulatory acceptance:

• Originator protection has already fallen away in many jurisdictions, enabling multiple biosimilar launches.
• Remaining originator exclusivity and any supplementary protections still affect pricing and switching schedules region by region.
• Payer contracting accelerates or slows adoption independent of clinical evidence, based on tender outcomes.

Implication for revenue durability

• In markets where biosimilars have secured broad formulary access, adalimumab revenue shifts toward:
  • Residual originator demand (patient preference, prescriber practice, medical necessity exceptions)
  • Higher discounting pressure and faster margin compression

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How big is the biosimilar “share shift” risk?

Adalimumab is structurally exposed to biosimilar displacement because:

• It is a long-established therapy with extensive prescribing volume.
• TNF-class biologics often show therapeutic interchangeability in payer-driven switching models.
• Biosimilars use reference product endpoints and manufacturing comparability packages aligned to regulatory pathways.

Payer-driven switching mechanics

In practice, adalimumab biosimilar share gains follow:

• Tender wins and step-therapy requirements
• Institutional switching for stable patients
• Formulary substitution at pharmacy benefit level

Commercial impact is expressed through:

• Faster adoption than clinical trial uptake cycles
• Persistent pricing downward pressure even after initial share capture

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What is the projected market trajectory for adalimumab through 2030?

A practical projection must separate: 1) Total addressable patient demand (driven by incidence, prevalence, guideline adherence) 2) Originator share (driven by biosimilar contracting) 3) Net realized pricing (driven by discounts and mix)

Directionally expected outcomes (2026–2030)

• Originator revenue:
  • Continues to decline in most major markets as biosimilar penetration increases.
  • Stabilizes only where payer formularies still retain originator positioning via contracts or patient-level constraints.
• Overall TNF market share distribution:
  • Reallocates toward biosimilars, with potential consolidation among fewer manufacturers over time due to pricing and volume economics.
• Pipeline resilience:
  • New indications or refined regimens can defend baseline demand, but they typically cannot offset systemic biosimilar pricing pressure at scale.

Projection bands (operational, not point estimates)

Because no quantitative baseline dataset was supplied in the prompt, the projection is framed as a decision-useful directional model:

Metric	2026–2027	2028–2030
Originator net pricing	Further compression	Lower flat-to-declining trajectory
Originator share in core markets	Continued decline	Slower decline as penetration saturates
Total biologics demand in indications	Mild growth/flat	Flat-to-slight growth tied to epidemiology and guideline adherence
Competitive intensity	High	High, with rationalization possible

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What commercial risks are most material for investors and R&D strategists?

Risk 1: Biosimilar penetration accelerates faster than originator contracting

Payer behavior often changes formulation mix within contract periods, leaving limited recovery time.

Risk 2: Margin erosion from discounting

Even where originator share persists, net pricing declines under tender pressure.

Risk 3: Safety or efficacy perceptions in switching cohorts

Switching can be managed clinically, but payer and patient acceptance can swing based on tolerability and loss of response narratives.

Risk 4: Competitive repositioning by other TNF biologics and IL-pathway agents

Therapeutic alternatives in RA, PsA, and IBD increasingly include IL-17, IL-23, IL-6, and JAK inhibitors, which can change sequencing strategy.

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What R&D implications follow from the current clinical and market setup?

Adalimumab’s development model shifts from “add new blockbuster” to “defend clinical placement”:

• Program selection favors evidence that changes treatment sequencing (first-line, post-failure, combination rationale).
• Design priorities focus on payer-relevant endpoints (persistence, durable response, reduced healthcare utilization).
• Route and administration improvements target adherence and real-world persistence.

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Key Takeaways

• Adalimumab remains the dominant TNF antibody by historic scale, but originator economics face sustained biosimilar-driven pricing and share pressure through 2030.
• Clinical development remains active, concentrated on label refinement, evidence generation, and practical regimen optimization rather than first-in-class replacement.
• Market projections through 2030 are dominated by payer contracting and biosimilar penetration curves, not by incremental clinical gains alone.
• Investor and R&D focus should be on durability of share under tendering conditions, and on trials that support sequencing and persistence where biosimilars compete on price.

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FAQs

1) Is adalimumab still a top biologic in RA, IBD, and spondyloarthritis?

Yes. Adalimumab remains a core TNF option with broad use across RA, PsA, AS, CD, and UC, even as biosimilars erode originator share.

2) Why do biosimilars continue to reduce adalimumab originator performance?

They win contracting and formulary placement faster than clinical switching cycles, driving net price compression and share transfer.

3) What kind of adalimumab trials matter most commercially now?

Trials that support treatment positioning through endpoints tied to durability, persistence, and real-world effectiveness.

4) Will adalimumab’s market decline stop once penetration saturates?

Penetration can saturate in some geographies, but originator net pricing typically stays under pressure as competition remains active.

5) What is the main strategic lever for brand survival?

Securing durable formulary access and minimizing switching loss through contract terms, patient-level controls, and evidence that supports persistence.

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References

[1] U.S. Food and Drug Administration. Humira (adalimumab) prescribing information and related safety/labeling documentation. (FDA label).
[2] European Medicines Agency. Humira product information and biosimilar regulatory frameworks. (EMA documentation).
[3] ClinicalTrials.gov. Adalimumab clinical trial registry entries. (database query).
[4] World Health Organization. Guidance and background on biosimilars and biologics regulation. (WHO materials).