Rituximab-abbs - Biologic Drug Details

Summary for rituximab-abbs

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

Pharmacology for rituximab-abbs

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-abbs Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

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

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for Rituximab-abbs

Introduction

Rituximab-abbs, a biosimilar to the biologic drug Rituxan (rituximab), has significantly impacted the market dynamics and financial trajectories in the treatment of non-Hodgkin's lymphoma and other indications. Here, we delve into the key aspects of this biosimilar's market performance and financial implications.

Market Adoption and Share

As of Q1 2024, biosimilars of rituximab have captured a substantial market share, with the biosimilar share of the rituximab market reaching 75%, an increase of 2% from the previous quarter[1].

• Truxima, one of the earliest biosimilars to rituximab, has been a significant player in this market. Practices that switched to Truxima saved nearly 8% of the cost of rituximab per episode, highlighting the cost-effectiveness of biosimilars[2].

Average Sales Price (ASP) Trends

The average ASP of all rituximab products has declined significantly since the introduction of biosimilars. As of Q3 2024, the average ASP of all products is $1,863, a drop of 58% from the reference product's ASP at the time of the first biosimilar launch. For biosimilars alone, the average ASP is $1,262, a 72% reduction[1].

• Price Erosion: The entry of biosimilars has led to considerable price erosion. For instance, the ASP of Riabni, a later entrant, has declined, allowing it to grow in market share[1].

Cost Savings

The adoption of rituximab-abbs has resulted in substantial cost savings for healthcare systems and payers.

• Medicare Savings: In the Oncology Care Model (OCM), practices that switched to rituximab-abbs saved between $1,400 and $1,700 per episode on average. For a medium-sized practice with 150 lymphoma episodes per year, this could translate to savings of $150,000 to $200,000 annually[2].

Market Competition

The rituximab biosimilar market is highly competitive, with multiple products vying for market share.

• Market Share Distribution: As of Q3 2024, Truxima, Ruxience, Riabni, and other biosimilars share the market. Lower-priced biosimilars dominate the market, with Riabni gaining market share as its ASP declines[1].

Global Market Growth

The global market for rituximab biosimilars is experiencing robust growth.

• CAGR: The global rituximab biosimilars market is expected to grow at a compound annual growth rate (CAGR) of 13.6% from 2022 to 2026, reaching $3.42 billion by 2026[4].

Regulatory and Approval Landscape

The FDA approval of rituximab-abbs has been a critical factor in its market success.

• FDA Approval: TRUXIMA (rituximab-abbs) was approved by the FDA in 2018 for three non-Hodgkin's lymphoma indications, marking a significant milestone in the biosimilar market[5].

Impact on Biologic Drug Prices

The entry of biosimilars like rituximab-abbs has led to significant price reductions for biologic drugs.

• Price Reductions: Studies have shown that biologic drug prices can drop by 6.6% to 66.0% one to five years after the entry of biosimilars, depending on the drug, indication, and geographic setting[3].

Utilization and Expenditures

The impact of biosimilars on utilization and expenditures is profound.

• Utilization Shifts: The introduction of biosimilars has led to shifts in utilization patterns. For example, the share of tumor necrosis factor inhibitors (TNFis) in the rheumatoid arthritis treatment market is projected to decrease, while Janus kinase inhibitors (JAKinibs) are expected to increase[3].

Challenges and Opportunities

Despite the benefits, there are challenges and opportunities in the biosimilar market.

• Competition and Pricing: Biosimilar manufacturers face intense competition and pricing pressures. The ability to maintain market share often depends on formulary placement and manufacturer-payer dynamics[3].

• Regulatory Environment: The regulatory environment plays a crucial role. Payers and manufacturers must navigate complex healthcare regulations, reimbursement policies, and intellectual property laws[5].

Key Takeaways

• Market Share: Biosimilars of rituximab have captured a significant market share, with a 75% share as of Q1 2024.
• Cost Savings: The adoption of rituximab-abbs has led to substantial cost savings for healthcare systems and payers.
• Price Erosion: The entry of biosimilars has resulted in significant price erosion, with ASPs dropping by up to 72%.
• Global Growth: The global rituximab biosimilars market is expected to grow at a CAGR of 13.6% from 2022 to 2026.
• Regulatory Approval: FDA approval has been crucial for the market success of rituximab-abbs.

FAQs

Q: What is the current market share of rituximab biosimilars? A: As of Q1 2024, the biosimilar share of the rituximab market is 75%[1].

Q: How much cost savings can be achieved by switching to rituximab-abbs? A: Practices can save between $1,400 and $1,700 per episode on average by switching to rituximab-abbs[2].

Q: What is the projected growth rate of the global rituximab biosimilars market? A: The global rituximab biosimilars market is expected to grow at a CAGR of 13.6% from 2022 to 2026[4].

Q: How have biosimilars affected the prices of biologic drugs? A: Biosimilars have led to significant price reductions, with biologic drug prices dropping by 6.6% to 66.0% one to five years after biosimilar entry[3].

Q: What are the key factors influencing the market success of rituximab-abbs? A: Key factors include FDA approval, formulary placement, manufacturer-payer dynamics, and competitive pricing strategies[1][3][5].

Sources

1. Samsung Bioepis. Biosimilar Market Dynamics - SAMSUNG BIOEPIS. Q3 2024.
2. AJMC. Biosimilars Drive Savings in Medicare's Oncology Care Model. June 19, 2021.
3. Tandfonline. Estimating the impact of biosimilar entry on prices and expenditures. 2022.
4. Biosimilar Development. Rituximab Biosimilars Global Market Report 2023. February 13, 2023.
5. Business Wire. Celltrion and Teva Announce FDA Approval of TRUXIMA® (rituximab-abbs). November 28, 2018.