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

Hyrimoz: A Comprehensive Overview of Clinical Trials, Market Analysis, and Projections

Introduction to Hyrimoz

Hyrimoz, developed by Sandoz, is a biosimilar version of AbbVie’s blockbuster drug Humira (adalimumab), a tumor necrosis factor (TNF) blocker. This biosimilar has been approved for various indications, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, and Crohn’s disease[4].

Clinical Trials and Evidence

The approval of Hyrimoz was based on a robust dataset from comprehensive analytical, functional, and clinical studies. Here are the key points from these trials:

• Analytical and Functional Studies: These studies confirmed the structural and functional similarity between Hyrimoz and the reference product, Humira. This step is crucial in establishing the biosimilarity of the two drugs[1][3].

• Pharmacokinetic Studies: These studies were conducted in healthy volunteers to investigate the pharmacokinetic similarity between Hyrimoz and Humira. The results showed that the pharmacokinetic profiles of the two drugs were comparable[1].

• Clinical Trials: The ADMYRA trial was a pivotal study that included patients with moderate to severe rheumatoid arthritis who had an inadequate response to disease-modifying anti-rheumatic drugs. Patients were randomized to receive either Hyrimoz or the reference product, with some patients switching from the reference product to Hyrimoz at week 24. The trial demonstrated that Hyrimoz had efficacy, safety, and immunogenicity profiles matching those of the reference product, with no impact on safety and immunogenicity after switching[1].

Market Analysis

Current Market Performance

Since its launch in July 2023, Hyrimoz has shown significant market traction. Here are some key market metrics:

• Sales Growth: In the first quarter of 2024, Sandoz reported a 21% increase in biosimilar sales, driven largely by Hyrimoz, which contributed to a 6% overall growth rate for the company. Biosimilar sales represented 25% of Sandoz’s total sales, up from 22% in the same period the previous year[2].

• Prescription Trends: Following CVS Caremark’s decision to remove Humira from its national commercial formularies and favor biosimilars, prescriptions for Hyrimoz skyrocketed. In the week ending April 5, 2024, new prescriptions for Hyrimoz increased from approximately 640 to 8,300, accounting for 93% of the growth in biosimilar prescriptions[5].

• Market Share: Hyrimoz has captured a significant market share, with data from IQVIA showing that it accounted for 82% of the biosimilar prescriptions written for adalimumab as of April 25, 2024[2].

Competitive Landscape

Hyrimoz operates in a competitive market with several other Humira biosimilars, including Amgen’s Amjevita, Celltrion’s Yuflyma, Organon and Samsung Bioepis’ Hadlima, and Alvotech and Teva’s Simlandi. However, Hyrimoz stands out due to its citrate-free and high-concentration formulation, which makes its onset of effect more rapid and its injections less painful compared to other biosimilars[5].

Pricing Strategy

Hyrimoz is sold at an 80% discount to Humira, significantly reducing the cost burden for patients and healthcare systems. This pricing strategy, combined with its preferred access to 65% of CVS’s commercial business, has been a key factor in its market success[2][5].

Projections and Future Outlook

Sales Projections

Analysts expect Sandoz’s biosimilar business, led by Hyrimoz, to continue driving significant growth. The company is projected to see mid-single-digit percentage sales growth in 2024, with biosimilars becoming an increasingly larger part of its business[2].

Future Launches

Sandoz is planning to launch biosimilars for other blockbuster drugs, including Biogen’s Tysabri, Regeneron and Bayer’s Eylea, Amgen’s Prolia, and Johnson & Johnson’s Stelara. These future launches are expected to further bolster the company’s biosimilar portfolio and drive continued growth[2].

Regulatory Considerations

While Hyrimoz has not yet received the FDA’s interchangeability designation, which would allow it to be substituted for the branded reference product without consulting the prescriber, its current market performance suggests strong acceptance by both prescribers and patients. This trend is likely to continue as more data on its safety and efficacy becomes available[5].

Key Indications and Benefits

Hyrimoz is indicated for several autoimmune diseases, including:

• Rheumatoid Arthritis: Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA[4].

• Juvenile Idiopathic Arthritis: Reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 4 years of age and older[4].

• Psoriatic Arthritis: Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA[4].

• Ankylosing Spondylitis: Reducing signs and symptoms in adult patients with active AS[4].

• Crohn’s Disease: Treatment of moderately to severely active CD[4].

Conclusion

Hyrimoz has established itself as a significant player in the biosimilar market, particularly in the treatment of autoimmune diseases. With strong clinical evidence supporting its biosimilarity to Humira, a favorable market environment, and aggressive pricing strategies, Hyrimoz is poised for continued growth and market dominance.

Key Takeaways

• Robust Clinical Evidence: Hyrimoz has demonstrated biosimilarity to Humira through comprehensive analytical, functional, and clinical studies.
• Strong Market Performance: Hyrimoz has seen a significant increase in prescriptions and sales following its launch and favorable formulary decisions.
• Competitive Advantage: Its citrate-free and high-concentration formulation provides a more rapid onset of effect and less painful injections.
• Future Growth: Sandoz is expected to continue expanding its biosimilar portfolio, driving further growth.
• Regulatory Considerations: While not yet interchangeability designated, Hyrimoz’s market acceptance is strong.

FAQs

Q: What is Hyrimoz and how does it compare to Humira?

Hyrimoz is a biosimilar version of AbbVie’s Humira (adalimumab). It has been shown through clinical trials to have similar efficacy, safety, and immunogenicity profiles to Humira.

Q: What are the key indications for Hyrimoz?

Hyrimoz is indicated for rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, and Crohn’s disease.

Q: How has the market responded to Hyrimoz since its launch?

The market response has been positive, with a significant increase in prescriptions and sales, particularly after CVS Caremark removed Humira from its national commercial formularies.

Q: Does Hyrimoz have any unique formulation advantages?

Yes, Hyrimoz has a citrate-free and high-concentration formulation, which makes its onset of effect more rapid and its injections less painful compared to other biosimilars.

Q: What are the future growth prospects for Hyrimoz and Sandoz’s biosimilar business?

Analysts expect Sandoz’s biosimilar business to continue growing, driven by future launches of biosimilars for other blockbuster drugs and the ongoing success of Hyrimoz.

Sources

1. The Totality of Evidence Supporting the Approval of Adalimumab Biosimilar GP2017 - Center for Biosimilars
2. Sandoz delivers 6% sales growth with Humira biosimilar leading the charge - FiercePharma
3. Summary Basis of Decision for Hyrimoz - Health Canada
4. Hyrimoz - accessdata.fda.gov - FDA
5. Sandoz's Biosimilar Skyrockets After CVS Removes AbbVie's Humira From Formularies - BioSpace

Last updated: 2025-01-18