RITUXAN HYCELA Drug Profile

Summary for Tradename: RITUXAN HYCELA

High Confidence Patents:	0
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for RITUXAN HYCELA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for RITUXAN HYCELA

Recent Clinical Trials for RITUXAN HYCELA

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Academic and Community Cancer Research United	Phase 2
National Cancer Institute (NCI)	Phase 2
National Cancer Institute (NCI)	Phase 3

See all RITUXAN HYCELA clinical trials

Recent Litigation for RITUXAN HYCELA

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
AbbVie Inc. v. Hetero USA, Inc.	2024-08-08
Acerta Pharma B.V. v. Cipla Limited	2024-05-16
AbbVie Inc. v. Hetero USA, Inc.	2023-11-20

See all RITUXAN HYCELA litigation

PTAB Litigation

Petitioner	Date
Sandoz Inc.	2023-02-03
Celltrion, Inc. et al.	2022-02-21
Fresenius Kabi USA, LLC	2021-09-24

See all RITUXAN HYCELA litigation

Pharmacology for RITUXAN HYCELA

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 RITUXAN HYCELA Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

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

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Genentech, Inc.	RITUXAN HYCELA	rituximab and hyaluronidase human	Injection	761064	10,004,694	2032-09-12	Patent claims search
Genentech, Inc.	RITUXAN HYCELA	rituximab and hyaluronidase human	Injection	761064	10,004,745	2030-06-03	Patent claims search
Genentech, Inc.	RITUXAN HYCELA	rituximab and hyaluronidase human	Injection	761064	10,005,783	2028-10-22	Patent claims search
Genentech, Inc.	RITUXAN HYCELA	rituximab and hyaluronidase human	Injection	761064	10,016,338	2033-03-11	Patent claims search

Market Dynamics and Financial Trajectory for RITUXAN HYCELA

Introduction to RITUXAN HYCELA

RITUXAN HYCELA, a combination subcutaneous treatment of rituximab and hyaluronidase, has emerged as a significant player in the biologic drug market, particularly in the treatment of various lymphomas and autoimmune diseases. Here, we delve into the market dynamics and financial trajectory of this drug.

Clinical Indications and Approval

RITUXAN HYCELA is indicated for the treatment of adult patients with non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukemia (CLL), and certain autoimmune diseases. The FDA approval stipulates that the subcutaneous option can only be used following one initial dose of IV-administered rituximab[1][2].

Market Competition

The market for anti-CD20 treatments, where RITUXAN HYCELA operates, is highly competitive. Roche, the developer of RITUXAN HYCELA, has also introduced other treatments like Gazyva, which, although not as successful as Rituxan in some trials, is expected to make a significant impact in the follicular lymphoma market. GlobalData forecasts that Gazyva's global sales will increase from $564 million in 2019 to $2 billion in 2026[1].

Biosimilars Market Impact

The approval of rituximab biosimilars, such as RIABNI (rituximab-arrx) by Amgen Inc., has added another layer of competition. These biosimilars are expected to drive the market growth, with the rituximab biosimilars market projected to reach $4.89 billion by 2028 at a CAGR of 12.8%[3].

Patient Support Programs

Patient support programs play a crucial role in the market dynamics of RITUXAN HYCELA. Programs like the Genentech Oncology Co-pay Assistance Program help eligible patients with commercial insurance pay as little as $0 per treatment, increasing accessibility and driving market growth[5].

Government Initiatives and Regulatory Environment

Increasing government initiatives and updated FDA regulations for biosimilar drugs are key factors contributing to the growth of the rituximab biosimilars market. These initiatives help in broadening research and development, and in creating effective and innovative biosimilars[3][4].

Financial Trajectory

Market Size and Growth

The rituximab biosimilars market, which includes RITUXAN HYCELA, is expected to see rapid growth. The market size is projected to reach $4.89 billion by 2028, driven by factors such as an aging population, improved access to healthcare, and an increasing prevalence of chronic diseases like non-Hodgkin's lymphoma and autoimmune diseases[3].

Regional Market Performance

North America was the largest region in the rituximab biosimilars market in 2023, with the Middle East expected to be the fastest-growing region during the forecast period. The regional segmentation highlights the diverse market dynamics and growth opportunities for RITUXAN HYCELA and its biosimilars[3].

Sales Projections

GlobalData's forecasts indicate significant sales growth for Roche’s related products, such as Gazyva, which is expected to increase from $564 million in 2019 to $2 billion in 2026. While specific sales projections for RITUXAN HYCELA are not detailed, its inclusion in the broader rituximab market suggests a substantial financial trajectory[1].

Clinical Development and Efficacy

The clinical development program for RITUXAN HYCELA has shown that the overall response rates are comparable to those of the original IV-administered Rituxan. This equivalence in efficacy, combined with the convenience of subcutaneous administration, makes RITUXAN HYCELA an attractive option for patients and healthcare providers[2].

Side Effects and Safety Considerations

While RITUXAN HYCELA offers several benefits, it also comes with serious side effects, including severe mucocutaneous reactions, hepatitis B virus reactivation, and progressive multifocal leukoencephalopathy. These safety considerations are crucial for both patients and healthcare providers, and ongoing monitoring is necessary to manage these risks[2][5].

Strategic Partnerships and Research

Key players in the rituximab biosimilars market are actively engaged in strategic partnerships and collaborations to broaden research and development initiatives. These partnerships are essential for creating effective and innovative biosimilars, further driving the market growth and financial trajectory of RITUXAN HYCELA[3].

Conclusion

The market dynamics and financial trajectory of RITUXAN HYCELA are influenced by a combination of factors, including competitive market dynamics, patient support programs, government initiatives, and the broader biosimilars market growth. As the demand for rituximab biosimilars continues to rise, driven by increasing prevalence of chronic diseases and improved access to healthcare, RITUXAN HYCELA is poised to play a significant role in the biologic drug market.

Key Takeaways

• Market Growth: The rituximab biosimilars market, including RITUXAN HYCELA, is expected to grow to $4.89 billion by 2028.
• Competitive Landscape: RITUXAN HYCELA faces competition from other anti-CD20 treatments and biosimilars.
• Patient Support: Programs like the Genentech Oncology Co-pay Assistance Program enhance accessibility.
• Regulatory Environment: Updated FDA regulations and government initiatives support market growth.
• Clinical Efficacy: RITUXAN HYCELA has comparable efficacy to IV-administered Rituxan.
• Safety Considerations: Serious side effects require careful monitoring.

FAQs

What is RITUXAN HYCELA used for?

RITUXAN HYCELA is used for the treatment of adult patients with non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukemia (CLL), and certain autoimmune diseases.

How is RITUXAN HYCELA administered?

RITUXAN HYCELA is administered subcutaneously, but it requires an initial dose of IV-administered rituximab.

What are the potential side effects of RITUXAN HYCELA?

Potential side effects include severe mucocutaneous reactions, hepatitis B virus reactivation, and progressive multifocal leukoencephalopathy.

How does the market for RITUXAN HYCELA look in terms of growth?

The market for rituximab biosimilars, including RITUXAN HYCELA, is expected to grow to $4.89 billion by 2028 at a CAGR of 12.8%.

What role do patient support programs play in the market for RITUXAN HYCELA?

Patient support programs, such as the Genentech Oncology Co-pay Assistance Program, help make RITUXAN HYCELA more accessible by reducing out-of-pocket costs for patients.

Sources

1. Biosimilar Development: "Rituxan Biosimilars In The Real World Market And Clinical Considerations"
2. Rituxan Hycela: "Clinical Development Program | RITUXAN HYCELA"
3. Research and Markets: "Rituximab Biosimilars Global Market Size & Forecast to 2028"
4. Business Wire: "Global Follicular Lymphoma Therapeutics Market 2018-2022"
5. Rituxan Hycela: "Financial Assistance Options - Rituxan Hycela"

Last updated: 2024-12-18