CLINICAL TRIALS PROFILE FOR TRUXIMA

Biosimilar Clinical Trials for TRUXIMA

This table shows clinical trials for biosimilars. See the next table for all clinical trials

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT04323956 ↗	Parsaclisib Plus the Standard Drug Therapy in Patients With Newly Diagnosed, High Risk Diffuse Large B-cell Lymphoma	Recruiting	National Cancer Institute (NCI)	Phase 1	2020-06-15	This phase I/Ib trial studies the side effects and best dose of parsaclisib plus the standard drug therapy (rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone [R-CHOP]) and to see how well they work compared with R-CHOP alone in treating patients with newly diagnosed, high risk diffuse large B-cell lymphoma. Parsaclisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, and vincristine sulfate, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Anti-inflammatory drugs, such as prednisone, lower the body's immune response and are used with other drugs in the treatment of some types of cancer. It is not yet known if giving parsaclisib and R-CHOP together works better than R-CHOP alone in treating patients with high risk diffuse large B-cell lymphoma.
NCT04323956 ↗	Parsaclisib Plus the Standard Drug Therapy in Patients With Newly Diagnosed, High Risk Diffuse Large B-cell Lymphoma	Recruiting	Mayo Clinic	Phase 1	2020-06-15	This phase I/Ib trial studies the side effects and best dose of parsaclisib plus the standard drug therapy (rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone [R-CHOP]) and to see how well they work compared with R-CHOP alone in treating patients with newly diagnosed, high risk diffuse large B-cell lymphoma. Parsaclisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, and vincristine sulfate, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Anti-inflammatory drugs, such as prednisone, lower the body's immune response and are used with other drugs in the treatment of some types of cancer. It is not yet known if giving parsaclisib and R-CHOP together works better than R-CHOP alone in treating patients with high risk diffuse large B-cell lymphoma.
NCT04555811 ↗	FT596 With Rituximab as Relapse Prevention After Autologous HSCT for NHL	Recruiting	Masonic Cancer Center, University of Minnesota	Phase 1	2020-09-22	This is a Phase I multi-center study to evaluate the safety of FT596 when given with rituximab as relapse prevention in patients who have undergone an autologous hematopoietic stem cell transplant (auto-HSCT) for diffuse large or high-grade B cell lymphoma.
NCT05406401 ↗	A Study of Zilovertamab Vedotin (MK-2140) in Combination With Cyclophosphamide, Doxorubicin, and Prednisone Plus Rituximab or Rituximab Biosimilar (Truxima) (R-CHP) in Participants With Diffuse Large B-Cell Lymphoma (DLBCL) (MK-2140-007)	Not yet recruiting	Merck Sharp & Dohme LLC	Phase 2	2022-06-28	This study consists of a dose escalation/confirmation phase and an efficacy expansion phase. The dose escalation/confirmation phase is to determine the safety and tolerability and establish a preliminary recommended Phase 2 dose (RP2D) of zilovertamab vedotin when administered in combination with R-CHP in participants with DLBCL who have received no prior treatment for their disease. The efficacy expansion phase is to determine the efficacy of the RP2D of zilovertamab vedotin when administered in combination with R-CHP in participants with DLBCL who have received no prior treatment for their disease.

All Clinical Trials for TRUXIMA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00293475 ↗	Methotrexate, Mannitol, Rituximab, and Carboplatin in Treating Patients With Newly Diagnosed Primary Central Nervous System Lymphoma	Active, not recruiting	National Cancer Institute (NCI)	Phase 1/Phase 2	2005-10-14	This phase I/II trial studies the side effects of methotrexate, mannitol, rituximab, and carboplatin and to see how well they work in treating patients with primary central nervous system lymphoma. Drugs used in chemotherapy, such as methotrexate and carboplatin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Osmotic blood-brain barrier disruption uses mannitol to open the blood vessels around the brain and allow cancer-killing substances to be carried directly to the brain. Monoclonal antibodies, such as rituximab, may block cancer growth in different ways by targeting certain cells. Giving methotrexate, mannitol, rituximab, and carboplatin together may be an effective treatment for primary central nervous system lymphoma.
NCT00293475 ↗	Methotrexate, Mannitol, Rituximab, and Carboplatin in Treating Patients With Newly Diagnosed Primary Central Nervous System Lymphoma	Active, not recruiting	Oregon Health and Science University	Phase 1/Phase 2	2005-10-14	This phase I/II trial studies the side effects of methotrexate, mannitol, rituximab, and carboplatin and to see how well they work in treating patients with primary central nervous system lymphoma. Drugs used in chemotherapy, such as methotrexate and carboplatin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Osmotic blood-brain barrier disruption uses mannitol to open the blood vessels around the brain and allow cancer-killing substances to be carried directly to the brain. Monoclonal antibodies, such as rituximab, may block cancer growth in different ways by targeting certain cells. Giving methotrexate, mannitol, rituximab, and carboplatin together may be an effective treatment for primary central nervous system lymphoma.
NCT00293475 ↗	Methotrexate, Mannitol, Rituximab, and Carboplatin in Treating Patients With Newly Diagnosed Primary Central Nervous System Lymphoma	Active, not recruiting	OHSU Knight Cancer Institute	Phase 1/Phase 2	2005-10-14	This phase I/II trial studies the side effects of methotrexate, mannitol, rituximab, and carboplatin and to see how well they work in treating patients with primary central nervous system lymphoma. Drugs used in chemotherapy, such as methotrexate and carboplatin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Osmotic blood-brain barrier disruption uses mannitol to open the blood vessels around the brain and allow cancer-killing substances to be carried directly to the brain. Monoclonal antibodies, such as rituximab, may block cancer growth in different ways by targeting certain cells. Giving methotrexate, mannitol, rituximab, and carboplatin together may be an effective treatment for primary central nervous system lymphoma.
NCT00412594 ↗	Cladribine and Rituximab in Treating Patients With Hairy Cell Leukemia	Recruiting	Genentech, Inc.	Phase 2	2004-06-10	This phase II trial studies the side effects and how well cladribine and rituximab work in treating patients with hairy cell leukemia. Drugs used in chemotherapy, such as cladribine, work in different ways to stop the growth of cancer cells either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as rituximab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cladribine together with rituximab may kill more cancer cells.
NCT00412594 ↗	Cladribine and Rituximab in Treating Patients With Hairy Cell Leukemia	Recruiting	National Cancer Institute (NCI)	Phase 2	2004-06-10	This phase II trial studies the side effects and how well cladribine and rituximab work in treating patients with hairy cell leukemia. Drugs used in chemotherapy, such as cladribine, work in different ways to stop the growth of cancer cells either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as rituximab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cladribine together with rituximab may kill more cancer cells.

Clinical Trial Conditions for TRUXIMA

Condition Name

Condition Name for TRUXIMA
Intervention	Trials
Recurrent Diffuse Large B-Cell Lymphoma	13
Acute Lymphoblastic Leukemia	10
Refractory Diffuse Large B-Cell Lymphoma	10
Leukemia	9

Condition MeSH

Condition MeSH for TRUXIMA
Intervention	Trials
Lymphoma	67
Lymphoma, B-Cell	32
Leukemia	29
Lymphoma, Large B-Cell, Diffuse	27

Clinical Trial Locations for TRUXIMA

Trials by Country

Trials by Country for TRUXIMA
Location	Trials
United States	543
Canada	18
Belgium	5
Germany	3
Japan	2

Trials by US State

Trials by US State for TRUXIMA
Location	Trials
Texas	44
California	21
New York	21
Ohio	17
Minnesota	17

Clinical Trial Progress for TRUXIMA

Clinical Trial Phase

Clinical Trial Phase for TRUXIMA
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	11
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for TRUXIMA
Clinical Trial Phase	Trials
Recruiting	48
Active, not recruiting	19
Not yet recruiting	17

Clinical Trial Sponsors for TRUXIMA

Sponsor Name

Sponsor Name for TRUXIMA
Sponsor	Trials
National Cancer Institute (NCI)	63
M.D. Anderson Cancer Center	33
University of Washington	4

Sponsor Type

Sponsor Type for TRUXIMA
Sponsor	Trials
Other	93
NIH	63
Industry	34

Clinical Trials Update, Market Analysis and Projection for TRUXIMA

Last updated: November 3, 2025

Introduction

TRUXIMA (rituximab-abbs) stands as a biosimilar counterpart to Roche’s blockbuster drug Rituxan (rituximab), initially approved by the FDA in 2018. Developed by Teva Pharmaceuticals in partnership with Celltrion Healthcare, TRUXIMA has expanded access to targeted immunotherapy in hematological malignancies and autoimmune disorders, primarily non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia (CLL), and rheumatoid arthritis (RA). This analysis provides an updated overview of the clinical trials landscape, market dynamics, and future growth projections for TRUXIMA, informing stakeholders about its evolving role in biosimilar pharmaceuticals.

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Clinical Trials Landscape and Recent Developments

Ongoing and Completed Clinical Trials

Since its initial approval, TRUXIMA's clinical development has focused on expanding indications, optimizing formulations, and assessing safety and efficacy compared to the reference product Rituxan. Recent updates include:

• NHL and CLL Trials: Multiple phase III trials have demonstrated bioequivalence of TRUXIMA to Rituxan, reinforcing its therapeutic comparability across indications. The SABRINA study (NCT02105576) evaluated subcutaneous versus intravenous administration in patients with indolent NHL, showing non-inferiority and improved convenience, which has spurred further clinical research into administration routes.

• Autoimmune Disorders: Trials such as NCT03905733 are exploring TRUXIMA's efficacy in autoimmune conditions beyond RA, including ANCA-associated vasculitis and lupus nephritis, aiming to expand its label and market penetration.

• Combination Therapies: Investigational use with agents like obinutuzumab and newer targeted therapies signals ongoing efforts to explore synergistic regimens, potentially increasing the drug’s clinical utility.

Regulatory and Approval Status

Beyond the FDA approval in 2018, TRUXIMA has obtained approvals in multiple jurisdictions, including the European Union, Japan, and Australia. Regulatory filings consistently cite robust clinical data demonstrating equivalence with Rituxan, often supported by immunogenicity and safety profiles.

Recent Clinical Trial Challenges

While the biosimilar sector faces regulatory scrutiny regarding interchangeability and immunogenicity, TRUXIMA has maintained positive prospects. However, increased competition from newer targeted therapies and alternative biosimilars demands continuous post-marketing surveillance to ensure ongoing efficacy and safety.

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Market Analysis

Market Size and Growth Drivers

The global biosimilar market for oncology and autoimmune indications is expected to grow at a CAGR of approximately 28% over the next five years, driven by patent expirations of originator biologics, aggressive biosimilar market entries, and healthcare cost containment policies. As of 2022, the global rituximab market, valued at over USD 7 billion, is projected to reach USD 13 billion by 2030, with TRUXIMA capturing crucial market share due to its cost advantage and approved indications.

Key Market Players and Competition

TRUXIMA faces competition predominantly from:

• Celltrion’s Truxima (approved in 2017): The first biosimilar rituximab approved globally.
• Sandoz’s Rixathon (EU approval, 2019): Markets in Europe.
• Pfizer’s Ruxience (FDA approved, 2019): United States.
• Other biosimilars emerging from companies like Samsung Bioepis and Biocon.

Despite the crowded landscape, TRUXIMA has maintained its competitive edge through strategic pricing, broad indication approvals, and robust supply chains.

Market Penetration and Adoption Trends

In North America and Europe, TRUXIMA has gained significant traction, especially in oncology clinics aiming to reduce treatment costs. Its subcutaneous formulation, which received FDA approval in 2021, improves patient compliance and reduces infusion times, further bolstering adoption.

Asia-Pacific markets, notably Japan and South Korea, show increasing uptake, driven by government incentives for biosimilars, expanding healthcare budgets, and rising prevalence of lymphomas.

Pricing and Reimbursement Environment

Price reductions of up to 35% compared to the reference biologic have positioned TRUXIMA as a favored alternative. Reimbursement policies increasingly favor biosimilars, with payers negotiating favorable formulary placements, especially as biosimilar penetration improves overall treatment affordability.

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Future Market Projections

Growth Outlook (2023-2028)

The outlook for TRUXIMA remains optimistic, with projections estimating a Compound Annual Growth Rate (CAGR) of approximately 12% globally. Factors supporting this outlook include:

• Expanded Indications: As ongoing trials confirm efficacy in additional autoimmune disorders, market size expands.
• Formulation Innovations: The subcutaneous formulation reduces administration costs and improves patient experience, likely leading to increased adoption.
• Market Penetration in Emerging Economies: Growth is anticipated in China, Brazil, and India, where biosimilar acceptance accelerates due to cost considerations.

Regulatory and Market Challenges

Potential challenges include:

• Patent litigations and exclusivity periods that may delay market entry of new biosimilars.
• Interchangeability debates, influencing physician prescribing behavior.
• Emerging novel therapies, including CAR-T and monoclonal antibody combinations, potentially competing with rituximab-based regimens.

Strategic Opportunities

• Partnerships with distribution networks for broader market access.
• Extension into new indications, such as MS or other autoimmune diseases.
• Patient-centric formulation development to improve compliance and outcomes.

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Key Takeaways

• TRUXIMA continues to solidify its position as a leading rituximab biosimilar through expanding indications, innovative formulations, and strategic market penetration.
• Clinical trial updates reaffirm its bioequivalence, safety, and potential for label expansion, especially in autoimmune conditions.
• The biosimilar market for rituximab is projected to grow robustly, with TRUXIMA poised to benefit from favorable pricing, regulatory support, and increasing clinician acceptance.
• Market challenges include stiff competition, regulatory hurdles, and evolving therapeutic landscapes; proactive strategies are vital to sustain growth.
• The integration of subcutaneous formulations further enhances its competitive advantage by improving treatment efficiency and patient preference.

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FAQs

1. What clinical evidence supports TRUXIMA’s biosimilarity to Rituxan?
Clinical trials, including phase III studies like SABRINA, have demonstrated pharmacokinetic, pharmacodynamic, efficacy, and safety equivalence between TRUXIMA and Rituxan across indications such as NHL. Immunogenicity profiles are comparable, confirming biosimilarity.

2. How does TRUXIMA's market position compare with other rituximab biosimilars?
TRUXIMA was among the first biosimilar rituximab approved globally, giving it early market entry advantage. It maintains a substantial market share due to proven efficacy, expanded formulations, and broad regulatory approvals, though competition from newer biosimilars remains intense.

3. What are the prospects for TRUXIMA in expanding autoimmune disease indications?
Ongoing trials aim to demonstrate efficacy in conditions like vasculitis and lupus nephritis. Positive results could lead to label expansion, broadening its market and increasing revenue streams.

4. How does the subcutaneous formulation impact TRUXIMA’s market?
Approved in 2021, the subcutaneous version simplifies administration, shortens infusion times, and enhances patient convenience, likely accelerating adoption in outpatient settings and increasing overall market share.

5. What are the main market growth drivers for TRUXIMA over the next five years?
Key drivers include expanding indications, innovative administration routes, competitive pricing, favorable reimbursement policies, and growth in emerging markets with increasing biosimilar acceptance.

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References

[1] FDA. (2018). FDA Approves First Biosimilar for Rituximab.
[2] Teva Pharmaceuticals. (2022). TRUXIMA Product Information.
[3] EvaluatePharma. (2022). Global Biosimilars Market Report.
[4] Celltrion Healthcare. (2021). Expansion of TRUXIMA Indications.
[5] IMS Health. (2022). Biosimilar Market Dynamics & Forecast.