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®.

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.

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: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: November 1, 2025

Introduction

Humira (adalimumab), developed by AbbVie, remains one of the world's top-selling biologic medicines. Primarily used to treat autoimmune conditions such as rheumatoid arthritis, psoriatic arthritis, Crohn's disease, and ulcerative colitis, Humira's market dominance has significantly shaped the biologics landscape. As key patents expire and biosimilar competition emerges, understanding the latest clinical trial developments, market dynamics, and future projections is vital for stakeholders across pharmaceutical, healthcare, and investment sectors.

Clinical Trials Update

Ongoing and Recent Clinical Trials

Humira continues to be involved in numerous clinical trials targeting additional indications and optimizing its therapeutic profile. Notably:

• Autoimmune and Inflammatory Diseases: Several Phase IV studies monitor long-term safety and efficacy in conditions like hidradenitis suppurativa and uveitis, expanding Humira's approved uses. For instance, trials initiated in 2022 investigate its role in axial spondyloarthritis (NCT04554805) and juvenile idiopathic arthritis (NCT03907723).

• Innovative Delivery and Formulations: Research aims to enhance patient compliance through new administration routes, including subcutaneous and auto-injector devices, reflected in trials like NCT04973894 evaluating improved delivery systems.

• Combination Therapy Trials: Investigations explore Humira in combination with other biologics or small molecules. These trials assess synergistic effects and safety profiles, especially in difficult-to-treat subsets.

COVID-19 Related Trials

Given the immune-modulating nature of Humira, some studies evaluate its impact on COVID-19 outcomes. These include observational studies assessing hospitalized patients receiving adalimumab, with mixed results on COVID-19 severity and immune response modulation (e.g., NCT04318297).

Regulatory and Post-Marketing Surveillance

AbbVie maintains extensive post-marketing surveillance to monitor adverse effects, reinforcing Humira's safety profile. Continuous data collection informs potential label updates and new indication approvals, such as experimental trials for inflammatory bowel disease (NCT04355745).

Market Analysis

Current Market Position

Humira generated approximately $20.4 billion in global revenue in 2022, maintaining its position as the world's top-selling pharmaceutical. Its dominant position is attributed to:

• Broad Indication Spectrum: Approved across multiple autoimmune diseases.
• Established Brand Loyalty: Long-standing clinical efficacy and safety record.
• Global Reach: Extensive access in North America, Europe, and emerging markets.

However, the market landscape faces imminent challenges:

• Patent Expirations: The primary U.S. patent expired in January 2023, opening pathways for biosimilars (e.g., Amgevita, Abrilada), which are gaining market share.

• Biosimilar Competition: Several biosimilars launched in the U.S. and EU, leading to price erosion. By 2025, biosimilars are projected to capture up to 30-40% of Humira's revenue in mature markets.

• Pricing Pressures and Payer Dynamics: Growing demand for biosimilar adoption exerts downward pricing pressures, especially in countries with cost-sensitive healthcare systems.

Emerging Markets and Regional Variations

In developing economies, Humira remains relatively dominant, often due to limited biosimilar availability or regulatory barriers. India and China, for instance, are witnessing increasing biosimilar penetration, which may influence Humira's market share regionally.

Regulatory Developments and Biosimilar Approvals

AbbVie’s strategic pathways include:

• Humira Biosimilars: Several biosimilars have obtained approval in multiple regions. Notably, Amgevita (Amgen/Samsung) and Hyrimoz (Sandoz) are marketed in the U.S. and EU, contributing to sales decline.

• Transition to New Molecules: AbbVie is developing next-generation immunomodulators, but none have yet replaced Humira's core revenue.

Market Projections

Short-Term Outlook (Next 1-3 Years)

• Revenue Decline: Due to biosimilar competition, US sales are projected to decline by approximately 30-50% by 2025, reflecting initial market penetration of biosimilars and price competition.

• Market Share Reallocation: Biosimilars are expected to dominate in the US and Europe, with industry estimates indicating that biosimilars could account for 60% of Humira's original market volume by 2024.

• Pipeline Expansion: Evidence suggests ongoing expansion into indications like hidradenitis suppurativa and uveitis may temporarily stabilize revenue through off-label uses, although regulatory approval remains critical.

Medium to Long-Term Outlook (5-10 Years)

• Market Stabilization and Growth in Emerging Countries: As biosimilar penetration plateaus globally, Humira's market could stabilize in non-competitive regions, maintaining a substantial revenue base.

• Potential for Formulation Innovation: Next-generation delivery methods and personalized immunomodulatory combinations could rejuvenate interest and extend patent protections indirectly.

• Shift Toward Value-Based Models: Payers emphasizing cost-effectiveness may favor biosimilars, potentially reducing Humira’s market share further but emphasizing the importance of lifecycle management strategies.

Future Revenue Projections

Industry analysts predict Humira’s global revenue will decline to approximately $10-12 billion annually by 2025, representing a significant but not terminal contraction. The precise figure hinges on factors like regulatory approvals of additional biosimilars, market acceptance, and evolving treatment paradigms.

Concluding Insights

AbbVie's Humira exemplifies a blockbuster biologic facing inevitable biosimilar competition, prompting strategic adaptations:

• Clinical Expansion: Ongoing trials aim to demonstrate additional indications and improve formulations, seeking to extend market relevance.

• Market Strategy: Aggressive biosimilar negotiations and value-based contracting are crucial as revenue declines accelerate.

• Innovation Focus: Investment in next-generation immunomodulators or delivery systems might create new revenue streams.

Understanding these dynamics enables stakeholders to navigate the evolving landscape effectively.

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Key Takeaways

• Clinical momentum: Humira continues to explore new indications and formulations through extensive clinical trials, supporting its long-term application scope.

• Market decline but resilience: Patent expiration and biosimilar entry will sharply reduce revenue; however, global markets, especially emerging economies, retain substantial demand.

• Strategic adaptation: Success hinges on lifecycle management, including biosimilar competition handling, innovation, and expanding indications.

• Regulatory landscape: Navigating approvals for biosimilars and new formulations remains essential to sustain market relevance.

• Future outlook: Revenue projections anticipate significant reduction by 2025, but with factors like biosimilar penetration and new indications influencing long-term stability.

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FAQs

1. How will biosimilar entry impact Humira’s market share in the U.S.?
Biosimilars launched post-patent expiry are expected to capture up to 60-70% of the original Humira volume by 2024–2025, leading to a steep revenue decline but preserving a residual niche for branded formulations.

2. Are there any new indications for Humira in clinical development?
Yes. Current trials are exploring additional uses such as hidradenitis suppurativa, uveitis, and certain Crohn's disease subtypes, aiming to extend its therapeutic reach.

3. What strategies is AbbVie employing to sustain Humira's relevance?
AbbVie is investing in formulation improvements, expanding indications via clinical trials, and seeking regulatory approval for biosimilar differentiators like enhanced delivery devices.

4. How do regional differences influence Humira’s market outlook?
Emerging markets have slower biosimilar adoption due to regulatory and price factors, offering some stability for Humira sales. Conversely, developed markets experience rapid biosimilar penetration, intensifying revenue challenges.

5. What long-term opportunities could offset declining Humira revenues?
Developing next-generation biologics, innovative delivery systems, and expanding into novel indications via clinical trials can create new revenue streams and extend the product lifecycle.

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Sources

1. AbbVie. Humira Data Sheet and Clinical Trial Information. [Online]. Available: https://www.humira.com
2. IQVIA. Global Biologics Market Report 2022.
3. FDA and EMA approval documents for biosimilars of Humira.
4. Industry analyst projections and peer-reviewed publications.