Rituximab-pvvr - Biologic Drug Details

Summary for rituximab-pvvr

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	1

Pharmacology for rituximab-pvvr

Mechanism of Action	CD20-directed Antibody Interactions
Established Pharmacologic Class	CD20-directed Cytolytic Antibody

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 rituximab-pvvr Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for rituximab-pvvr Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for rituximab-pvvr Derived from Patent Text Search

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for the Biologic Drug: Rituximab-pvvr

Introduction

Rituximab-pvvr, marketed as Ruxience, is a biosimilar of the biologic drug rituximab, which is used to treat various conditions including non-Hodgkin lymphoma, chronic lymphocytic leukemia, and certain autoimmune diseases. The introduction of rituximab-pvvr has significantly impacted the market dynamics and financial trajectory of rituximab products.

Market Uptake of Rituximab-pvvr

Since its introduction in 2019, rituximab-pvvr has seen a rapid uptake in the US market. By 2022, it had become a significant player in the rituximab market:

• Medicare Part B: Annual claims for rituximab-pvvr increased from 6% in 2020 to 33% of all Medicare Part B rituximab claims by 2022[1].
• Medicare Part D: The share of claims for rituximab-pvvr rose from 1% in 2020 to 17% by 2022[1].
• Medicaid: The claims for rituximab-pvvr grew from 5% in 2020 to 35% by 2022[1].

This rapid adoption is indicative of the market's acceptance and preference for biosimilar alternatives.

Financial Impact on Rituximab Market

The introduction of rituximab-pvvr has had a substantial financial impact on the rituximab market:

• Total Spending: By 2022, the total spending on rituximab-pvvr had increased to 23% of Medicare Part B spending on all rituximab products, 11% of Medicare Part D spending, and 24% of Medicaid spending[1].
• Cost Savings: The average sales price (ASP) of rituximab-pvvr decreased significantly, with a drop of 26% in Medicare Part B and 18% in Medicaid compared to the originator rituximab in 2022[1].

Price Trends

The ASP of rituximab-pvvr has been a key factor in its market success:

• ASP Reduction: The ASP of rituximab-pvvr decreased by 26% in Medicare Part B and 18% in Medicaid in 2022 compared to the previous year[1].
• Market Leader: As of Q3 2022, rituximab-pvvr (Ruxience) has become the market leader in the rituximab biosimilar market, with a significant share of the volume market[4].

Impact on Reference Rituximab

The rise of rituximab-pvvr has led to a decline in the market share and spending on the reference rituximab:

• Claims Decline: The annual number of claims for reference rituximab declined from 100% to 40% in Medicare Part B, from 100% to 59% in Medicare Part D, and from 93% to 39% in Medicaid by 2022[1].
• Spending Decline: The total spending on reference rituximab decreased from 100% to 55% in Medicare Part B, from 100% to 68% in Medicare Part D, and from 100% to 53% in Medicaid by 2022[1].

Market Share and Volume

By Q3 2023, the biosimilar share of the rituximab market, including rituximab-pvvr, had reached 73%:

• Volume Market Share: Rituximab-pvvr (Ruxience) holds a significant volume market share, making it the market leader among rituximab biosimilars[4].

Economic Benefits

The introduction of rituximab-pvvr has brought substantial economic benefits:

• Cost Savings: The decrease in ASP and the increased market share of biosimilars like rituximab-pvvr have led to significant cost savings for payers and patients. For example, the average ASP of all rituximab products decreased by 57%, and for biosimilars alone, it decreased by 70% as of Q1 2024[4].
• Healthcare System Savings: The overall spending on rituximab products has decreased, with annual total spending for all rituximab products dropping by 40% for Medicare Part B, 10% for Medicare Part D, and 20% for Medicaid compared to pre-biosimilar launch levels[2].

Regulatory and Competitive Landscape

The regulatory environment and competitive landscape play crucial roles in the market dynamics of rituximab-pvvr:

• Regulatory Approvals: The FDA approval process and subsequent market entry have been pivotal in the rapid uptake of rituximab-pvvr. The product received FDA approval and has since become a leading biosimilar in the market[1].
• Competitive Market: The rituximab market is highly competitive, with multiple biosimilars available, including rituximab-abbs (Truxima) and rituximab-arrx (Riabni). However, rituximab-pvvr has managed to secure a dominant position[1][4].

International Context

The success of rituximab-pvvr in the US market is mirrored in other regions:

• European Market: In Europe, where multiple biosimilars are approved, the uptake of rituximab biosimilars is also high, reaching about 70% within three years of biosimilar launch[1].

Conclusion

The market dynamics and financial trajectory of rituximab-pvvr are characterized by rapid market uptake, significant cost savings, and a substantial impact on the reference rituximab market. As the market leader among rituximab biosimilars, rituximab-pvvr continues to drive cost efficiency and accessibility in the treatment of various conditions.

Key Takeaways

• Rapid Market Uptake: Rituximab-pvvr has seen a rapid increase in claims and market share since its introduction.
• Cost Savings: The product has led to significant reductions in ASP and total spending on rituximab products.
• Market Leadership: Rituximab-pvvr has become the market leader among rituximab biosimilars.
• Regulatory and Competitive Landscape: FDA approval and a competitive market have contributed to its success.
• International Context: The uptake of rituximab biosimilars is high in both the US and European markets.

FAQs

Q: What is the current market share of rituximab-pvvr in the US? A: As of Q3 2023, the biosimilar share of the rituximab market, including rituximab-pvvr, has reached 73%, with rituximab-pvvr being the market leader[4].

Q: How has the introduction of rituximab-pvvr affected the cost of rituximab treatments? A: The introduction of rituximab-pvvr has led to a significant decrease in the ASP of rituximab products, with a 57% decrease in the average ASP of all products and a 70% decrease for biosimilars alone as of Q1 2024[4].

Q: What is the impact of rituximab-pvvr on the reference rituximab market? A: The annual number of claims and total spending on reference rituximab have declined substantially since the introduction of rituximab-pvvr, with a decline from 100% to 40% in Medicare Part B claims and from 100% to 55% in spending by 2022[1].

Q: How does the regulatory environment influence the market dynamics of rituximab-pvvr? A: FDA approval and subsequent market entry have been crucial for the rapid uptake of rituximab-pvvr. Regulatory approvals have enabled the product to become a leading biosimilar in the market[1].

Q: What are the economic benefits of rituximab-pvvr for healthcare systems? A: The introduction of rituximab-pvvr has led to significant cost savings for payers and patients, with overall spending on rituximab products decreasing by 40% for Medicare Part B, 10% for Medicare Part D, and 20% for Medicaid compared to pre-biosimilar launch levels[2].

Sources

1. The American Journal of Managed Care: "Uptake of Rituximab Biosimilars in Medicare and Medicaid in 2019-2022"[1].
2. The American Journal of Managed Care: "No Easy Path to Market for Alvotech's Adalimumab Biosimilar"[2].
3. Taylor & Francis Online: "Estimating the impact of biosimilar entry on prices and expenditures"[3].
4. Samsung Bioepis: "Biosimilar Market Report - Q1 2024"[4].

Last updated: 2024-12-20