CLINICAL TRIALS PROFILE FOR HYRIMOZ

All Clinical Trials for HYRIMOZ

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT05090124 ↗	Experimental Medicine Studies of Brain and Peripheral Immune Mechanisms for Sickness Behaviours in Patients With Rheumatoid Arthritis	Not yet recruiting	University of Glasgow	N/A	2022-01-01	The rationale for this study is to use immune molecule-specific drug treatment to leverage a mechanistic understanding of the brain changes that drive sickness behaviour. This will combine current therapy with innovative neuroimaging technologies to obtain data in humans that has hitherto only been available in animal studies. Data supporting the role of inflammatory molecules in sickness behaviours and other cognitive disorders are increasingly compelling. A putative mechanism linking inflammatory proteins to sickness behaviour is Tumour Necrosis Factor (TNF)-driven increases in extracellular glutamate leading to changes in neural function and brain network integrity and ultimately to sickness behaviour. Investigators hypothesise that TNF antagonism will effect changes in brain network connectivity and sickness behaviour score, that Rheumatoid Arthritis (RA) patients will show changes in brain network connectivity and glutamate quantification in the brain and that RA patients will show changes in monocyte infiltration into the brain that are correlated with changes in sickness behaviours. This is a randomised, placebo-controlled waiting list study. All patients will be eligible for anti-TNF treatment i.e. moderate to severe active disease as defined by Physician. Participants will be randomised to immediate (fast tracked) treatment or to treatment after 6-8 weeks (the routine waiting time). The latter group will receive placebo during the treatment phase.
NCT05090124 ↗	Experimental Medicine Studies of Brain and Peripheral Immune Mechanisms for Sickness Behaviours in Patients With Rheumatoid Arthritis	Not yet recruiting	NHS Greater Glasgow and Clyde	N/A	2022-01-01	The rationale for this study is to use immune molecule-specific drug treatment to leverage a mechanistic understanding of the brain changes that drive sickness behaviour. This will combine current therapy with innovative neuroimaging technologies to obtain data in humans that has hitherto only been available in animal studies. Data supporting the role of inflammatory molecules in sickness behaviours and other cognitive disorders are increasingly compelling. A putative mechanism linking inflammatory proteins to sickness behaviour is Tumour Necrosis Factor (TNF)-driven increases in extracellular glutamate leading to changes in neural function and brain network integrity and ultimately to sickness behaviour. Investigators hypothesise that TNF antagonism will effect changes in brain network connectivity and sickness behaviour score, that Rheumatoid Arthritis (RA) patients will show changes in brain network connectivity and glutamate quantification in the brain and that RA patients will show changes in monocyte infiltration into the brain that are correlated with changes in sickness behaviours. This is a randomised, placebo-controlled waiting list study. All patients will be eligible for anti-TNF treatment i.e. moderate to severe active disease as defined by Physician. Participants will be randomised to immediate (fast tracked) treatment or to treatment after 6-8 weeks (the routine waiting time). The latter group will receive placebo during the treatment phase.
NCT05502731 ↗	Januse Kinase Inhibition With Filgotinib to Silence Autoreactive B Cells in Rheumatoid Arthritis	Not yet recruiting	Galapagos NV	Phase 4	2022-10-01	To investigate the effect of filgotinib on phenotype, B cell receptor (BCR) usage and functional parameters of circulating B cells expressing ACPA in patients with ACPA-positive RA that show incomplete response to standard, medium-dose methotrexate (MTX) monotherapy.
NCT05502731 ↗	Januse Kinase Inhibition With Filgotinib to Silence Autoreactive B Cells in Rheumatoid Arthritis	Not yet recruiting	Leiden University Medical Center	Phase 4	2022-10-01	To investigate the effect of filgotinib on phenotype, B cell receptor (BCR) usage and functional parameters of circulating B cells expressing ACPA in patients with ACPA-positive RA that show incomplete response to standard, medium-dose methotrexate (MTX) monotherapy.

Clinical Trial Conditions for HYRIMOZ

Condition Name

Condition Name for HYRIMOZ
Intervention	Trials
Rheumatoid Arthritis	2

Condition MeSH

Condition MeSH for HYRIMOZ
Intervention	Trials
Arthritis, Rheumatoid	2
Arthritis	2
Illness Behavior	1

Clinical Trial Locations for HYRIMOZ

Trials by Country

Trials by Country for HYRIMOZ
Location	Trials
Netherlands	1

Clinical Trial Progress for HYRIMOZ

Clinical Trial Phase

Clinical Trial Phase for HYRIMOZ
Clinical Trial Phase	Trials
Phase 4	1
N/A	1

Clinical Trial Status

Clinical Trial Status for HYRIMOZ
Clinical Trial Phase	Trials
Not yet recruiting	2

Clinical Trial Sponsors for HYRIMOZ

Sponsor Name

Sponsor Name for HYRIMOZ
Sponsor	Trials
University of Glasgow	1
NHS Greater Glasgow and Clyde	1
Galapagos NV	1

Sponsor Type

Sponsor Type for HYRIMOZ
Sponsor	Trials
Other	3
Industry	1

Clinical Trials Update, Market Analysis, and Projection for HYRIMOZ

Last updated: November 5, 2025

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Introduction

HYRIMOZ (adalimumab-adbm) represents a biosimilar to Humira (adalimumab), developed by Samsung Bioepis and licensed through a strategic partnership with Biogen. As one of the leading biosimilars in the autoimmune therapeutics market, HYRIMOZ aims to capture significant market share by offering a cost-effective alternative for conditions such as rheumatoid arthritis, Crohn’s disease, psoriasis, and other inflammatory disorders. This comprehensive review assesses the current status of clinical trials, analyzes the market landscape, and projects future growth trajectories for HYRIMOZ.

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Clinical Trials Progress

Regulatory Pathways and Approvals

HYRIMOZ received its initial regulatory approval in Europe in 2018, after demonstrating biosimilarity to the reference product, Humira. The approval was based on comprehensive analytical studies, pharmacokinetic/pharmacodynamic (PK/PD) assessments, and clinical evaluations confirming comparable efficacy, safety, and immunogenicity profiles.

In the U.S., the FDA approved HYRIMOZ in 2019 through the 351(k) biosimilar pathway, emphasizing rigorous comparative clinical trials to establish biosimilarity. These trials included pivotal phase III studies focusing on rheumatoid arthritis and ankylosing spondylitis.

Ongoing and Completed Clinical Trials

• Phase III Trials in Rheumatoid Arthritis (RA): These evaluated efficacy, safety, and immunogenicity in biologic-naive and switching patients. Results consistently demonstrated equivalence to Humira, with no statistically significant differences in ACR20/50/70 response rates or adverse event profiles [1].

• Pediatric and Special Population Studies: Trials in juvenile idiopathic arthritis and psoriasis have been conducted or are underway, aimed at expanding indications.

• Switching Studies: Multiple real-world evidence and controlled switching studies confirm that patients transitioning from Humira to HYRIMOZ maintain disease control without increased adverse events, supporting interchangeability claims [2].

• Pharmacovigilance and Post-Marketing Surveillance: Post-approval data reveal a safety profile congruent with the reference biologic, with no new safety signals identified so far.

Recent Developments

Recent updates indicate stable production processes, enhanced manufacturing efficiencies, and ongoing pharmacovigilance efforts. HYRIMOZ continues to deepen its clinical portfolio, aiming to extend indications, including hidradenitis suppurativa and more complex autoimmune diseases.

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Market Landscape Analysis

Global Market Overview

The biosimilars segment for adalimumab is among the most competitive, driven by patent expirations of Humira beginning in 2018 in the U.S. and EU. The global adalimumab biosimilars market size was valued at approximately USD 2.5 billion in 2022 [3].

Key players include Amgen’s Amjevita, Samsung/Biogen’s HYRIMOZ, and other entrants such as Sandoz, Celltrion, and Pfizer. The market growth is propelled by increasing prevalence of autoimmune conditions, healthcare cost containment pressures, and regulatory support for biosimilar adoption.

Regional Dynamics

• Europe: As early adopters of biosimilars, European markets exhibit high penetration rates, with physicians demonstrating confidence in biosimilar interchangeability.

• United States: The market remains competitive, with payers actively incentivizing biosimilar use through formulary preferences and tiering strategies.

• Emerging Markets: Adoption is growing, notably in Asia-Pacific and Latin America, driven by cost considerations and expanding healthcare infrastructure.

Market Penetration and Competitive Positioning

HYRIMOZ holds a notable position due to:

• Pricing strategy: Approximately 15-30% lower than Humira, facilitating rapid uptake.

• Registry and switching data: Strong clinical evidence supports switching from Humira, reducing prescriber hesitance.

• Strategic partnerships: Inclusion in multiple formularies and access programs enhances reach.

However, intense competition necessitates ongoing differentiation strategies, including indication expansion and lifecycle management.

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Market Projection and Future Outlook

Drivers of Growth

• Patent Expiry and Market Penetration: The expiry of Humira’s U.S. patent in 2023 opens significant opportunities for HYRIMOZ to expand its market share domestically.

• Healthcare Cost Savings: Payers’ preference for biosimilars to mitigate escalating drug costs will promote adoption.

• Expanded Indications: Regulatory approval for additional autoimmune diseases will broaden the revenue base.

• Physician and Patient Acceptance: Increasing comfort with biosimilar switching and interchangeability enhances market penetration.

Forecasted Market Trends (2023–2028)

• Compound Annual Growth Rate (CAGR): Projected CAGR for HYRIMOZ is estimated at approximately 12-15%, reflecting accelerated biosimilar adoption trends.

• Revenue Projections: By 2028, revenues could reach USD 1.5–2 billion globally, assuming successful indication expansion and stable market share.

• Regional Variations: The U.S. will lead growth, driven by patent expirations and supportive policies; Europe will remain mature with sustained demand, while emerging markets will exhibit robust growth.

• Competitive Challenges: Entry of new biosimilars and originator efforts to innovate may influence market dynamics, possibly tempering growth rates.

Strategic Opportunities

• Lifecycle Management: Developing new formulations, delivery devices, and indications.

• Partnership Extensions: Collaborations with payers and healthcare providers to incentivize biosimilar prescribing.

• Digital Engagement: Use of digital health tools to educate stakeholders about biosimilar safety and efficacy.

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Conclusion

HYRIMOZ sustains a strong clinical and commercial profile based on its confirmed biosimilarity, strategic clinical trial conduct, and market positioning. The biosimilar’s trajectory aligns with the broader autoimmune therapeutics market’s shift toward cost-effective biologics, especially post-Humira patent expiration. Continued emphasis on indication expansion, evidence generation, and stakeholder engagement will be pivotal in securing its long-term growth.

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Key Takeaways

• Robust Clinical Evidence: HYRIMOZ’s approval is underpinned by comprehensive phase III trials demonstrating efficacy, safety, and immunogenicity on par with Humira.

• Market Opportunity Post-Patent Expiry: The U.S. patent cliff in 2023 paves the way for substantial market share gains, supported by favorable payer policies.

• Regional Adoption Variance: European markets exhibit mature biosimilar acceptance, while emerging markets offer high-growth opportunities.

• Growth Projections: The global biosimilar adalimumab market is expected to grow at a CAGR of 12-15% through 2028, with HYRIMOZ poised to capitalize on these trends.

• Strategic Focus Areas: Indication expansion, lifecycle management, and stakeholder education are essential to maintain competitive edge.

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FAQs

1. What are the primary indications approved for HYRIMOZ?
   HYRIMOZ is approved for rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis, Crohn’s disease, and ulcerative colitis, mirroring Humira’s approved indications.

2. How does HYRIMOZ compare to other biosimilars in terms of efficacy and safety?
   Clinical trials confirm HYRIMOZ’s biosimilarity to Humira, with comparable efficacy, safety, and immunogenicity profiles. Its real-world data further supports its interchangeability.

3. What factors influence the adoption rate of HYRIMOZ globally?
   Regulatory acceptance, healthcare provider confidence, payer reimbursement policies, pricing strategies, and patient acceptance largely determine adoption rates.

4. What is the potential impact of biosimilar competition on HYRIMOZ’s market share?
   While intense competition persists, inherent advantages such as pricing, proven biosimilarity, and clinical data positioning HYRIMOZ favorably, although market share may fluctuate based on new entrant dynamics.

5. What future clinical trial developments are expected for HYRIMOZ?
   Ongoing trials aim at expanding indications, including complex autoimmune conditions, and evaluating long-term safety and efficacy in diverse populations.

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References

[1] European Medicines Agency (EMA). HYRIMOZ: Summary of Product Characteristics.

[2] U.S. Food and Drug Administration (FDA). Approved Biosimilars List.

[3] MarketsandMarkets. Biosimilars Market Report, 2023.