Rituximab and hyaluronidase human - Biologic Drug Details

Summary for rituximab and hyaluronidase human

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

Pharmacology for rituximab and hyaluronidase human

Mechanism of Action	CD20-directed Antibody Interactions
Established Pharmacologic Class	CD20-directed Cytolytic Antibody Endoglycosidase
Chemical Structure	Glycoside Hydrolases

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 and hyaluronidase human Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for rituximab and hyaluronidase human Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for rituximab and hyaluronidase human Derived from Patent Text Search

No patents found based on company disclosures

Rituximab and hyaluronidase human Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Rituximab and Hyaluronidase Human

Introduction

Rituximab, a genetically engineered chimeric murine/human monoclonal antibody, has been a cornerstone in the treatment of various lymphomas and leukemias. The introduction of Rituxan Hycela, a combination of rituximab and hyaluronidase human, has significantly altered the market dynamics and financial trajectory of this biologic drug.

Background of Rituximab and Hyaluronidase Human

Rituxan Hycela is a subcutaneous formulation that combines rituximab with recombinant human hyaluronidase (rHuPH20), facilitating faster absorption and administration compared to the traditional intravenous (IV) form of rituximab[1][5].

FDA Approval and Indications

The U.S. Food and Drug Administration (FDA) approved Rituxan Hycela in June 2017 for the treatment of adult patients with follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), and chronic lymphocytic leukemia (CLL). This approval includes various treatment scenarios such as relapsed or refractory FL, previously untreated FL and DLBCL in combination with chemotherapy, and maintenance therapy for FL and CLL[5].

Pharmacokinetics and Efficacy

Clinical trials have shown that Rituxan Hycela achieves equal or higher trough concentrations (Ctrough) of rituximab compared to IV rituximab, with a fixed-dose regimen that eliminates the need for body surface area (BSA)-based dosing. The addition of hyaluronidase human enhances the absorption rate of rituximab, making the subcutaneous administration as effective as the IV form[1].

Safety Profile

The safety profile of Rituxan Hycela is comparable to that of IV rituximab, with the exception of an increased incidence of administration site-related local reactions. However, these reactions are generally mild and manageable[1].

Market Impact and Cost Savings

The transition from IV to subcutaneous rituximab has significant market and financial implications. Here are some key points:

Cost Savings

Studies have shown that transitioning patients from IV to subcutaneous rituximab can generate substantial cost savings for payers and healthcare providers. A model estimating the cost differences projected that a 20% transition of patients to subcutaneous rituximab could save payers over $150,000 and free up considerable provider and patient time[2].

Provider Capacity

The shorter administration time of subcutaneous rituximab (5-7 minutes) compared to IV infusion (several hours) increases provider capacity. This can result in savings of up to 270 hours of provider time and 470 hours of patient time per cohort[2].

Patient Convenience

The subcutaneous route offers greater convenience for patients, reducing the time spent in healthcare settings. This can lead to improved patient satisfaction and adherence to treatment regimens.

Biosimilar Market Dynamics

Even with the presence of biosimilars, transitioning to subcutaneous rituximab remains cost-effective. Scenario analyses indicate that cost savings are maintained even when biosimilars have a significant market share[2].

Financial Trajectory

Sales and Revenue

The introduction of Rituxan Hycela has contributed to the overall revenue of its manufacturer, Genentech Inc. While specific financial figures for Rituxan Hycela are not isolated, the broader category of rituximab and its biosimilars has seen significant market presence. For instance, Amgen's biosimilar to Rituxan, RIABNI, has been part of their successful biosimilar portfolio, contributing to their overall revenue growth[3].

Competitive Landscape

The anti-CD20 treatment space is highly competitive, with multiple players including originators and biosimilar manufacturers. Rituxan Hycela's unique formulation and administration route provide a competitive edge, although it does not eliminate the need for initial IV dosing in some cases[4].

Clinical and Economic Benefits

Clinical Benefits

Rituxan Hycela offers non-inferior efficacy compared to IV rituximab, with the added benefit of a simpler and faster administration process. This can improve patient compliance and reduce the burden on healthcare resources[1][5].

Economic Benefits

The economic benefits are multifaceted, including reduced administration costs, increased provider capacity, and significant time savings for both providers and patients. These factors contribute to a more efficient and cost-effective healthcare delivery system[2].

Future Outlook

Market Share and Growth

As more patients transition to subcutaneous rituximab, the market share of Rituxan Hycela is expected to grow. This growth will be driven by its convenience, efficacy, and cost savings.

Biosimilar Competition

The presence of biosimilars will continue to influence the market dynamics. However, the unique advantages of Rituxan Hycela, such as its subcutaneous administration and fixed dosing, are likely to maintain its market position.

Regulatory and Clinical Developments

Ongoing and future clinical trials may further expand the indications for Rituxan Hycela, potentially increasing its market reach and financial impact.

Key Takeaways

• Convenience and Efficacy: Rituxan Hycela offers a convenient subcutaneous administration route with non-inferior efficacy compared to IV rituximab.
• Cost Savings: Transitioning to subcutaneous rituximab can generate significant cost savings for payers and healthcare providers.
• Market Impact: The introduction of Rituxan Hycela has altered the competitive landscape in the anti-CD20 treatment space.
• Financial Trajectory: The drug contributes to the revenue growth of its manufacturer and is expected to maintain a strong market position despite biosimilar competition.

FAQs

What is Rituxan Hycela?

Rituxan Hycela is a combination of rituximab and hyaluronidase human, approved for the treatment of follicular lymphoma, diffuse large B-cell lymphoma, and chronic lymphocytic leukemia, administered subcutaneously.

How does Rituxan Hycela differ from IV rituximab?

Rituxan Hycela is administered subcutaneously, taking only 5-7 minutes, compared to the several hours required for IV infusion. It also uses a fixed-dose regimen instead of BSA-based dosing.

What are the cost savings associated with Rituxan Hycela?

Transitioning 20% of patients from IV to subcutaneous rituximab can save payers over $150,000 and free up significant provider and patient time.

Is Rituxan Hycela as effective as IV rituximab?

Yes, clinical trials have shown that Rituxan Hycela achieves equal or higher trough concentrations of rituximab compared to IV rituximab, with comparable efficacy and safety profiles.

How does the presence of biosimilars affect Rituxan Hycela?

Even with biosimilar competition, transitioning to subcutaneous rituximab remains cost-effective, with scenario analyses indicating continued cost savings for payers and providers.

Sources

1. FDA: "761064Orig1s000 - accessdata.fda.gov"
2. PLOS ONE: "Assessing the transition from intravenous to subcutaneous delivery of rituximab: Benefits for payers, health care professionals, and patients with lymphoma."
3. Amgen Inc.: "SHAREHOLDERS 2023"
4. Biosimilar Development: "Rituxan Biosimilars In The Real World Market And Clinical Considerations"
5. FDA: "FDA approves rituximab plus hyaluronidase combination for FL, DLBCL, and CLL"