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.
NCT03847467 ↗	Pilot and Feasibility Study of 2'-FL as a Dietary Supplement in IBD Patients Receiving Stable Maintenance Anti-TNF Therapy	Recruiting	Broad Institute	Phase 1/Phase 2	2019-09-20	Randomized, placebo-controlled dose-ranging study of 2'-FL in IBD, Crohn's Disease (CD) and ulcerative colitis (UC). The overarching hypothesis is that 2'-FL supplementation in IBD will be safe and well tolerated, while increasing fecal Bifidobacterium abundance and butyrate in a dose dependent manner. The investigators will test 1, 5, or 10 gm 2'-FL compared to 2 gm dextrose placebo as a daily dietary supplement in pediatric and young adult IBD participants in stable remission receiving infliximab, adalimumab, or infliximab-dyyb biosimilar anti-TNF therapy.

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.
NCT00185562 ↗	A Pilot Trial of Adalimumab for the Treatment of Osteoarthritis	Completed	Stanford University	Phase 2	2005-06-01	A 12 week trial of Adalimumab in subjects with active erosive inflammatory OA who have ahd an inadequate response to NSAID therapy

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 (Humira) clinical trials update, market analysis, and exclusivity-driven sales projection

Last updated: July 26, 2026

What is the latest clinical trials update for adalimumab (Humira), and which programs are active

Adalimumab is the dominant anti-TNF agent by revenue in the US and Europe, with a clinical pipeline focused on expanded indications, earlier-line use in inflammatory diseases, and formulation or delivery-administration improvements. Across the ecosystem, the largest trial activity clusters around (1) inflammatory bowel disease, (2) rheumatoid arthritis and related arthritides, (3) psoriasis and psoriatic arthritis, (4) ankylosing spondylitis and axial spondyloarthritis, and (5) pediatric populations under label-maintenance and treatment-optimization designs.

What indications drive current adalimumab clinical trial activity

Key active-theme trial areas (by therapeutic category):

• Rheumatoid arthritis (RA) and juvenile idiopathic arthritis (JIA): endpoints include ACR response, DAS28/CDAI-style activity measures, radiographic progression where applicable, durability, and immunogenicity monitoring.
• Psoriatic arthritis (PsA) and plaque psoriasis: typical endpoints include PASI90/PASI75, ACR/PsARC-style composite measures, and skin joint response durability.
• Inflammatory bowel disease (IBD): Crohn’s disease and ulcerative colitis trial endpoints are remission/response scales (e.g., CDAI-based in Crohn’s; partial Mayo in UC), plus endoscopic healing.
• Axial spondyloarthritis (including non-radiographic forms): endpoints include ASDAS change, BASDAI components, MRI features (where used), and treatment response durability.
• Extraintestinal immune-mediated indications: smaller trial sets aimed at specific subpopulations and biomarker-stratified response.

What trial design trends affect development timelines

• Real-world evidence alignment: later-phase designs incorporate treat-to-target and background-concomitant stratification consistent with practice.
• Switching and switching-risk studies: trials increasingly evaluate efficacy/safety after switching between anti-TNFs, particularly in IBD and RA subgroups.
• Pediatric bridging: dosing and safety rely on pharmacokinetic similarity with label-required immunogenicity surveillance.

What endpoints matter for licensing and payor positioning

• Sustained remission and steroid-sparing are the most commercially relevant endpoints in IBD and axial disease.
• Immunogenicity and infusion/injection-site tolerability influence formulary uptake in switching cohorts.
• Durability of response is a key driver for payer-authorized continuation criteria.

Operational note for business planning: public clinical-trial volume for adalimumab in 2024-2026 is shaped by label-maintenance work and competitive positioning rather than large first-in-class R&D. The near-term commercial swing is more tightly tied to competitive biosimilar share and payer utilization management than to new trial “breakthrough” outcomes.

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Which adalimumab biosimilars and generics are competing, and how that impacts revenue projections

Adalimumab’s commercial trajectory is dominated by biosimilar entry risk and substitution patterns in the US and EU. The revenue base is also affected by payer step therapy and pharmacy benefit management (PBM) dynamics as biosimilar penetration rises.

US competitive landscape: biosimilars and switching

• Multiple adalimumab biosimilars have launched in the US, enabling pharmacy substitution and payer-favored contracting.
• Switching from reference product is common when rebates and acquisition-cost thresholds are favorable.
• Contracting strategy increasingly targets biologic-naïve and maintenance cohorts via tiered formulary rules.

EU competitive landscape: substitution and tendering

• EU tendering for hospital-administered biologics often accelerates displacement.
• National formularies and procurement policies can move faster than reference-label exclusivity would suggest, because uptake depends on price and procurement status rather than trial novelty.

What market share movement typically looks like after biosimilar entry

• Early phase: higher share capture by biosimilars with strong contracting and lower net price.
• Middle phase: reference product share stabilizes but continues to decline as additional biosimilars and switching protocols expand.
• Late phase: reference product becomes primarily “managed access” in higher-cost segments unless it holds on through rebates or differentiated administration convenience.

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When do adalimumab exclusivity and key patent expirations drive generic or biosimilar erosion

Adalimumab’s main market effects are already underway, with reference-product exclusivity ended long ago in most major markets. The current exclusivity regime functions as incremental “thickeners” via formulation, device, manufacturing, and method-of-use patents rather than as a single clean expiration date.

How to think about exclusivity vs biosimilar entry in adalimumab

• Regulatory exclusivity blocks certain biosimilar approval paths only in limited time windows.
• Patent estate determines launch timing through litigation and settlement, including product-specific and process/device claims.
• Manufacturing and process patents can delay non-infringing production even after reference exclusivity ends.

Commercial impact timeline framework

• Near-term (12-24 months): contract-driven share losses and incremental uptake shifts.
• Mid-term (2-4 years): further displacement in hospital and outpatient buy-and-bill segments as biosimilar portfolios expand and payor policies tighten continuation rules.
• Long-term (4-7 years): reference product becomes a legacy brand unless it maintains competitive pricing or differentiation (device convenience or bundled contracting).

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What is the Orange Book status of adalimumab, and why it matters for market entry

Adalimumab is a biologic. The Orange Book lists small-molecule drugs. For biologics, the key public licensing visibility is:

• FDA Biologics License Application (BLA) data
• Purple Book listings for biologics and biosimilars
• Patent listings and litigation information tied to biologic reference products

Practical business reading of “Orange Book status” for adalimumab

• The “Orange Book” concept does not directly govern biosimilar entry for adalimumab as it does for drugs like erlotinib or apixaban.
• For adalimumab, the relevant patent and exclusivity landscape is tracked through biosimilar-related patent listings and settlement/liability outcomes for BLA biosimilar programs.

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How strong is the patent estate for adalimumab formulations, devices, and manufacturing methods

Even though major reference-product exclusivity is historic, patent estates can still:

• restrict biosimilar applicants from using certain processes,
• constrain formulation or device replicability,
• affect interchangeability timing and marketing.

Patent estate categories that typically remain commercially relevant

• Formulation patents: buffer systems, stabilizers, protein aggregation controls.
• Device and delivery system patents: injection pens, syringes, autoinjectors, needle geometry, release mechanisms.
• Manufacturing method patents: upstream process controls, cell line processing, purification steps, viral clearance controls.
• Method-of-use patents: dosing regimens and therapeutic use in subsets; these are more likely to be contested or designed-around.

What to model for infringement risk

• Patent landscape mapping should focus on claims tied to the reference product’s current marketed presentation(s).
• When biosimilar programs settle early, the practical outcome is that the winning biosimilar locks in launch timing, leaving downstream challengers with later risk windows.

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What patent litigation has affected adalimumab biosimilar launches, and what settlement outcomes determine timing

Adalimumab biosimilar entry in the US is shaped by repetitive litigation patterns: Paragraph IV-equivalent disputes, device/formulation/process claim contests, and settlement agreements that create calendar-specific launch windows.

What litigation outcomes usually do to the launch curve

• Settlements often lead to delayed launch dates for certain applicants.
• The “winner” biosimilar cohort gains sustained share earlier due to contracting cycles.
• Subsequent biosimilar entrants face lower marginal friction once key process/device patents are cleared.

How this changes market projection assumptions

Market models should assume:

• reference product share declines are front-loaded after initial biosimilar wins,
• incremental biosimilar launches still cause additional erosion, but slower,
• uptake is more sensitive to net price and formulary tiering than to small differences in mechanism.

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Adalimumab clinical and commercial projections: base case, downside, and upside

Market sizing logic used for projection (framework)

Because adalimumab is a mature biologic, projections are best modeled from:

1. reference-product global net sales trend,
2. biosimilar penetration by region and channel,
3. payer continuation criteria effects,
4. reference-product rebate/contract responses,
5. uptake from biologic-naïve vs switch cohorts.

Base-case sales projection (directional)

• Reference adalimumab (Humira) US: continues to decline as biosimilar substitution becomes structurally entrenched through PBM incentives and hospital procurement.
• Reference adalimumab EU: declines persist as tendering and formulary policies favor biosimilars.
• Total global reference-product revenue: downward trajectory through the mid-term, with flattening only when reference discounts deepen enough to maintain managed access.

Downside scenario

• Faster substitution due to tighter payer continuation criteria (lower persistence among marginal responders).
• Additional competitive pressure from more biosimilar introductions or aggressive contracting.
• Higher share loss in IBD where deep discounts often drive early switching.

Upside scenario

• Stronger-than-expected retention due to patient-specific tolerability advantages in certain injection systems or treatment regimens.
• Rebate-led stabilization in top accounts, delaying further volume erosion.
• Slower tender cycles in hospital accounts.

Key driver: adalimumab is not priced like a novel therapy. Its revenue elasticity is driven by biosimilar contracting and payer switching policies, not trial outcomes.

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Which disease areas will see the biggest share losses for adalimumab

IBD

IBD drives a disproportionate share of biologic spend. As biosimilars become preferred, switching cohorts expand, especially where payers require non-reference use for renewals.

RA and spondyloarthritis

These markets are large and established, which accelerates displacement once biosimilar coverage is optimized. Continuation criteria influence persistence.

Psoriasis

Psoriasis can show slower transitions in some settings due to treatment stability and long maintenance cycles, but overall substitution tends to follow formulary policy.

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How does adalimumab compare with infliximab and other anti-TNFs in biosimilar displacement risk

Compared with other anti-TNFs, adalimumab’s displacement risk is structurally high because:

• its utilization is broad across multiple indications,
• its reference brand has high prior exposure, expanding the switchable population,
• its competitive pricing dynamics are well suited to tender and rebate mechanisms.

Relative to monoclonal competitors with fewer biosimilar options, adalimumab faces steady substitution pressure.

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What generic or biosimilar entry risks exist for adalimumab in manufacturing and interchangeability

Interchangeability and substitution hurdles

• Interchangeability standards in the US can affect pharmacy-level automatic substitution.
• Even when a biosimilar is approved, payer acceptance depends on contracting and clinical-support programs.

Manufacturing/IP barriers

• Process patents and formulation/device constraints can affect time-to-market for later biosimilars.
• However, the market typically clears once key patent blockers and manufacturing barriers are resolved through settlement or design-around.

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Key commercial signals to monitor for adalimumab (next 4 quarters)

• Net price erosion indicators in US PBM contracts.
• Share by channel: retail pharmacy vs specialty pharmacy vs buy-and-bill.
• Persistence metrics under payer continuation criteria.
• Uptake in IBD maintenance cohorts after biosimilar switches.
• Country-level tender outcomes in Europe.

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Key Takeaways

• Adalimumab’s clinical activity is now dominated by label maintenance and optimization across RA, PsA, psoriasis, axial disease, and IBD rather than novel mechanism breakthroughs.
• Revenue projections hinge on biosimilar penetration and payer contracting, not on new clinical efficacy signals.
• Exclusivity constraints are already mostly historic; the ongoing schedule risk is driven by patent estate residues (formulation/device/manufacturing) and prior litigation/settlement outcomes.
• Base-case expectation: continued downward sales for the reference brand, with speed determined by net pricing and substitution policies.

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FAQs

1) What data best predicts adalimumab reference sales decline?
Net price trends, biosimilar share capture by channel, and payer persistence/continuation rule tightening.

2) Do adalimumab clinical trial results still materially affect market share?
Usually less than biosimilar contracting. Trials can support label optimizations, but displacement is driven by access and price.

3) Which adalimumab indications are most sensitive to payer switching?
IBD maintenance and high-volume RA/spondyloarthritis cohorts where continuation criteria drive renewals.

4) How do device differences (pen vs syringe) affect biosimilar uptake?
They can influence patient and provider preference, but they rarely outweigh net pricing and formulary tiering once a biosimilar is contracted.

5) What makes later adalimumab biosimilar entrants harder?
Residual formulation/device/process patents, interchangeability strategy, and contracting cycles that favor earlier winners.

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References

1. U.S. Food and Drug Administration. Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations. FDA.
2. U.S. Food and Drug Administration. Biologics License Application (BLA) and approval information for adalimumab products and biosimilars. FDA.
3. European Medicines Agency. EPARs and updates for adalimumab biosimilar medicines. EMA.
4. ClinicalTrials.gov. Interventional studies for adalimumab by condition and status.