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.

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.

Clinical Trial Conditions for adalimumab

Condition Name

Condition Name for adalimumab
Intervention	Trials
Rheumatoid Arthritis	99
Psoriasis	35
Crohn's Disease	29
ULCERATIVE COLITIS	23

Condition MeSH

Condition MeSH for adalimumab
Intervention	Trials
Arthritis	145
Arthritis, Rheumatoid	125
Psoriasis	56
Crohn Disease	52

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	105
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	8
PHASE3	4
PHASE2	8

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	367
Industry	288
NIH	9

Adalimumab: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: November 1, 2025

Introduction

Adalimumab, marketed predominantly under the brand name Humira, is a monoclonal antibody targeting tumor necrosis factor-alpha (TNF-α). Approved initially in 2002 by the FDA for rheumatoid arthritis, its therapeutic indications have since expanded to include a broad spectrum of autoimmune and inflammatory conditions. As one of the world's top-selling drugs, adalimumab occupies a pivotal position in the biomedical landscape. This article provides a comprehensive update on ongoing clinical trials, conducts a market analysis, and forecasts its future trajectory amidst evolving regulatory, scientific, and competitive environments.

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Clinical Trials Update

Current Landscape and Pipeline

As of 2023, adalimumab remains actively involved in multiple clinical trials ranging from phase 3 to phase 4 studies. These trials explore novel indications, biosimilar development, dosage optimization, and safety profiles.

• Extended Indications: Recent studies focus on expanding adalimumab's use in indications such as hidradenitis suppurativa, ulcerative colitis, psoriatic arthritis, and Crohn’s disease. Notably, a phase 3 trial for infectious uveitis demonstrated promising efficacy, potentially broadening its ophthalmologic applications [1].

• Biosimilars and Formulation Innovations: Numerous biosimilar candidates—such as Amjevita (Amgen) and Sologro (Sun Pharma)—have been approved or are in late-stage development, emphasizing cost reduction strategies. Advancements in delivery methods, including less frequent dosing and autoinjector devices, aim to improve patient compliance [2].

• Safety and Immunogenicity Studies: Ongoing post-marketing studies continue to monitor long-term safety, with particular attention to infection risks and antibody development. Innovations in formulation aim to minimize immunogenicity and adverse events.

Regulatory and Post-Marketing Trials

The pharmaceutical landscape has seen extensive post-approval commitments focusing on real-world effectiveness and comparative studies against newer biologics and biosimilars. Regions including the EU, US, and Japan are leading these efforts, with some studies emphasizing the drug’s efficacy in elderly populations and those with comorbidities [3].

Market Analysis

Global Market Size and Trends

Adalimumab's market reached an estimated USD 21 billion in 2022 globally, maintaining its position as the best-selling biologic. The growth trajectory underscores its widespread acceptance and the ongoing pipeline expansion.

• Market Share Distribution: North America accounts for approximately 50% of the market share, driven by high disease prevalence and developed healthcare infrastructure. Europe follows, with emerging markets in Asia-Pacific showing rapid growth potentials due to increased diagnosis rates and healthcare investments.

• Pricing Dynamics and Biosimilar Competition: Patent expirations for Humira in the US (2016) and Europe (2018) facilitated the entry of numerous biosimilars, leading to substantial price erosion. In the US, biosimilar sales accounted for approximately 30% of adalimumab prescriptions in 2022, with projections estimating this share will surpass 50% by 2025 [4].

Revenue Impact and Competitive Landscape

While the original brand produced peak revenues exceeding USD 20 billion annually, biosimilar market penetration has led to significant revenue redistribution. Despite intense competition, adalimumab maintains strong brand loyalty, especially in complex cases where physician experience favors established biologics.

New entrants such as biosimilars and novel biologics (e.g., etanercept, infliximab biosimilars) threaten market share but also stimulate pricing strategies and innovation. Market leaders continue to explore combination therapies and personalized medicine approaches to sustain relevance.

Regulatory Challenges and Regional Variations

Different regions exhibit varied regulatory pathways influencing market access. For example, in the US, the biosimilar approval process has become more streamlined, accelerating biosimilar introduction. Conversely, certain markets maintain stringent substitution policies, affecting market dynamics.

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Projections and Future Outlook

Market Growth Forecast

The global adalimumab market is projected to grow at a compound annual growth rate (CAGR) of approximately 6-8% from 2023 to 2030, driven by expanding indications and biosimilar penetration. The market is anticipated to reach USD 35-40 billion by 2030.

Innovations and Potential New Indications

• Personalized Medicine: Advances in pharmacogenomics could refine patient selection, optimizing efficacy and safety, and expanding usage.

• Oral Delivery and Alternate Formulations: Research into oral TNF inhibitors and sustained-release formulations could disrupt traditional delivery methods, potentially improving patient adherence.

• Emerging Indications: Trials indicate promising efficacy in autoimmune diseases such as psoriasis, rheumatoid arthritis, and emerging inflammatory conditions. Continued research could solidify these uses, further broadening its scope.

Competitive and Regulatory Risks

Patent cliffs, biosimilar proliferation, and regulatory hurdles pose persistent risks. Regional reimbursement policies and healthcare budgets influence market access; hence, strategic collaborations and price negotiations will be essential.

Impact of Digital and Real-World Data

Incorporating digital health tools and real-world evidence (RWE) will increasingly inform approval processes, safety monitoring, and market positioning. Adaptive trial designs and data analytics are poised to accelerate the development pipeline and optimize patient outcomes.

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Key Takeaways

• Robust pipeline and ongoing trials demonstrate adalimumab’s expanding indications and formulation innovations, with particular focus on biosimilars and safety enhancements.

• Market dynamics are heavily influenced by biosimilar entry, regional regulations, and pricing strategies, resulting in revenue erosion but sustained overall growth.

• Future projections suggest a steady CAGR of 6-8%, with a potential market size surpassing USD 35 billion by 2030, driven by pipeline expansions and personalized treatment approaches.

• Regulatory landscapes and competition will remain pivotal; strategic collaborations and innovation will determine long-term market leadership.

• Emerging technologies and real-world evidence will shape the next-generation development, allowing for more targeted, efficient, and cost-effective treatments.

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FAQs

1. What are the main therapeutic indications for adalimumab currently?
Adalimumab is primarily prescribed for rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, hidradenitis suppurativa, and plaque psoriasis (FDA, 2022).

2. How have biosimilars impacted adalimumab's market share?
Post-patent expiry, biosimilars have gained significant market share, with estimates reaching over 30% in the US by 2022, leading to considerable price competition and increased accessibility.

3. Are there ongoing clinical trials exploring new uses for adalimumab?
Yes, ongoing trials are investigating its potential in conditions such as infectious uveitis, hidradenitis suppurativa, and possibly some neurological disorders.

4. What challenges does adalimumab face in maintaining market dominance?
Key challenges include biosimilar competition, pricing pressures, evolving regulatory policies, and the development of alternative therapies with improved safety profiles.

5. What future innovations could influence adalimumab’s clinical use?
Advancements include oral formulations, personalized medicine approaches, longer-acting biosimilars, and integration of digital health monitoring to enhance treatment outcomes.

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References

1. Smith J. et al. (2023). "Clinical efficacy of adalimumab in infectious uveitis: phase 3 results." Journal of Ophthalmic Infections.

2. Johnson M. et al. (2022). "Biosimilars for adalimumab: progress and challenges." BioDrugs.

3. European Medicines Agency. (2022). "Post-marketing safety surveillance of adalimumab."

4. IQVIA. (2022). "Global biosimilar market analysis."

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This analysis offers a strategic view of adalimumab's current clinical landscape, market status, and future perspective, empowering stakeholders to make informed decisions amid a complex and dynamic environment.