HYRIMOZ Drug Profile

Summary for Tradename: HYRIMOZ

High Confidence Patents:	0
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for HYRIMOZ

Recent Clinical Trials for HYRIMOZ

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Leiden University Medical Center	Phase 4
Galapagos NV	Phase 4
NHS Greater Glasgow and Clyde	N/A

See all HYRIMOZ clinical trials

Pharmacology for HYRIMOZ

Mechanism of Action	Tumor Necrosis Factor Receptor Blocking Activity
Established Pharmacologic Class	Tumor Necrosis Factor Blocker
Chemical Structure	Antibodies, Monoclonal

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. General brand-side disclosures

These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for HYRIMOZ Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for HYRIMOZ Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for HYRIMOZ Derived from Patent Text Search

No patents found based on company disclosures

HYRIMOZ Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Hyrimoz

Introduction to Hyrimoz

Hyrimoz, a biosimilar of AbbVie's Humira (adalimumab), has been gaining significant traction in the market. Developed by Sandoz, Hyrimoz is approved to treat seven conditions: rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and plaque psoriasis[5].

Market Share and Competition

The introduction of Hyrimoz has disrupted the market dynamics for Humira. Despite Humira's historical dominance, its market share has been eroding since biosimilars entered the market. As of May 2024, Humira's market share dropped to 82%, with biosimilars collectively taking around 18% of the market[1]. Hyrimoz, in particular, has made substantial gains, controlling 13% of the market[1].

Formulary Changes and Impact

CVS Caremark's decision to remove Humira from its major formularies in April 2024 significantly impacted Humira's market share. This move led to a surge in new prescriptions for Hyrimoz, with numbers increasing from 640 in the week ending March 29 to 8,300 in the week ending April 5[1]. The formulary changes have driven the share of new biosimilar prescriptions from less than 5% to 36% since April, indicating a substantial increase in biosimilar utilization[4].

Pricing Strategies

Pricing has been a key factor in the success of biosimilars. While Humira's pricing has not been a strong driver for its decline, biosimilars like Hyrimoz offer diverse pricing options. Some biosimilars, such as Samsung Bioepis' Hadlima and Coherus' Yusimry, cost around 85% lower than Humira[1]. This pricing strategy has made biosimilars more attractive to payers and patients.

Financial Performance of Sandoz

Sandoz, the manufacturer of Hyrimoz, has reported strong financial performance. In 2023, Sandoz's net sales for the full year were USD 2.5 billion, with a 9% increase in constant currencies compared to the previous year. The company's biosimilar segment saw a 15% growth in constant currencies, driven by the launch of Hyrimoz[2][3]. This growth reflects the increasing demand for biosimilars and Sandoz's strategic positioning in the market.

Future Prospects

The adalimumab biosimilar market is expected to grow at an annual rate of 24%, according to Data Bridge Market Research. As more biosimilars enter the market and competition intensifies, AbbVie is likely to face further erosion of its market share. To counter this, AbbVie is expanding its immunology portfolio with products like Skyrizi and Rinvoq, which could help maintain its franchise[5].

Key Takeaways

1. Market Share Erosion: Humira's market share has dropped significantly since biosimilars entered the market.
2. Formulary Changes: CVS Caremark's removal of Humira from its formularies has led to a surge in biosimilar prescriptions.
3. Pricing Strategies: Biosimilars offer competitive pricing options, making them more attractive to payers and patients.
4. Financial Performance: Sandoz has reported strong financial growth driven by the success of Hyrimoz.
5. Future Prospects: The adalimumab biosimilar market is expected to grow rapidly, with AbbVie facing increasing competition.

FAQs

1. What is Hyrimoz?

   • Hyrimoz is a biosimilar of AbbVie's Humira (adalimumab), approved to treat seven conditions including rheumatoid arthritis and psoriatic arthritis[5].

2. How has Hyrimoz impacted the market?

   • The introduction of Hyrimoz has significantly eroded Humira's market share, with biosimilars collectively taking around 18% of the market[1].

3. What are the key factors driving the success of biosimilars?

   • Competitive pricing and formulary changes are key factors. Biosimilars like Hyrimoz offer significant discounts compared to Humira, making them more attractive to payers and patients[1][4].

4. How has Sandoz performed financially?

   • Sandoz reported a 9% increase in net sales in constant currencies for 2023, driven by strong demand for biosimilars like Hyrimoz[2][3].

5. What are the future prospects for the adalimumab biosimilar market?

   • The market is expected to grow at an annual rate of 24%, with increasing competition from multiple biosimilars[5].