CLINICAL TRIALS PROFILE FOR RIABNI

All Clinical Trials for RIABNI

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT04965493 ↗	A Trial of Pirtobrutinib (LOXO-305) Plus Venetoclax and Rituximab (PVR) Versus Venetoclax and Rituximab (VR) in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)	Recruiting	Loxo Oncology, Inc.	Phase 3	2021-09-20	The purpose of this study is to compare the efficacy and safety of fixed duration pirtobruitinib (LOXO-305) with VR (Arm A) compared to VR alone (Arm B) in patients with CLL/SLL who have been previously treated with at least one prior line of therapy. Participation could last up to five years.
NCT05023980 ↗	A Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab (BR) in Untreated Patients With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)	Recruiting	Loxo Oncology, Inc.	Phase 3	2021-09-23	The purpose of this study is to compare the efficacy and safety of pirtobrutinib (LOXO-305; Arm A) compared to BR (Arm B) in patients with CLL/SLL who have not been treated. Participation could last up to five years.
NCT05453500 ↗	Chemotherapy (DA-EPOCH+/-R) and Targeted Therapy (Tafasitamab) for the Treatment of Newly-Diagnosed Philadelphia Chromosome Negative B Acute Lymphoblastic Leukemia	Not yet recruiting	Incyte Corporation	Phase 2	2023-01-01	This phase II clinical trial tests a chemotherapy regimen (dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide and doxorubicin with or without rituximab [DA-EPOCH+/-R]) with the addition of targeted therapy (tafasitamab) for the treatment of patients with newly diagnosed Philadelphia chromosome negative (Ph-) B acute lymphoblastic leukemia (B-ALL). Chemotherapy drugs, such as those in EPOCH+/-R, 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. Tafasitamab is in a class of medications called monoclonal antibodies. It works by helping the body to slow or stop the growth of cancer cells. Adding tafasitamab to the DA-EPOCH+/-R regimen may work better than DA-EPOCH+/-R alone in treating newly diagnosed Ph- B-ALL.
NCT05453500 ↗	Chemotherapy (DA-EPOCH+/-R) and Targeted Therapy (Tafasitamab) for the Treatment of Newly-Diagnosed Philadelphia Chromosome Negative B Acute Lymphoblastic Leukemia	Not yet recruiting	University of Washington	Phase 2	2023-01-01	This phase II clinical trial tests a chemotherapy regimen (dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide and doxorubicin with or without rituximab [DA-EPOCH+/-R]) with the addition of targeted therapy (tafasitamab) for the treatment of patients with newly diagnosed Philadelphia chromosome negative (Ph-) B acute lymphoblastic leukemia (B-ALL). Chemotherapy drugs, such as those in EPOCH+/-R, 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. Tafasitamab is in a class of medications called monoclonal antibodies. It works by helping the body to slow or stop the growth of cancer cells. Adding tafasitamab to the DA-EPOCH+/-R regimen may work better than DA-EPOCH+/-R alone in treating newly diagnosed Ph- B-ALL.
NCT05457556 ↗	Mismatched Related Donor Versus Matched Unrelated Donor Stem Cell Transplantation for Children, Adolescents, and Young Adults With Acute Leukemia or Myelodysplastic Syndrome	Not yet recruiting	Children's Oncology Group	Phase 3	2022-11-23	This phase III trial compares hematopoietic (stem) cell transplantation (HCT) using mismatched related donors (haploidentical [haplo]) versus matched unrelated donors (MUD) in treating children, adolescents, and young adults with acute leukemia or myelodysplastic syndrome (MDS). HCT is considered standard of care treatment for patients with high-risk acute leukemia and MDS. In HCT, patients are given very high doses of chemotherapy or radiation therapy, which is intended to kill cancer cells that may be resistant to more standard doses of chemotherapy; unfortunately, this also destroys the normal cells in the bone marrow, including stem cells. After the treatment, patients must have a healthy supply of stem cells reintroduced or transplanted. The transplanted cells then reestablish the blood cell production process in the bone marrow. The healthy stem cells may come from the blood or bone marrow of a related or unrelated donor. If patients do not have a matched related donor, doctors do not know what the next best donor choice is or if a haplo related donor or matched unrelated donor (MUD) is better. This trial may help researchers understand whether a haplo related donor or a MUD HCT for children with acute leukemia or MDS is better or if there is no difference at all.

Clinical Trial Conditions for RIABNI

Condition Name

Condition Name for RIABNI
Intervention	Trials
Chronic Lymphocytic Leukemia	3
Small Lymphocytic Lymphoma	2
High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements	1
High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 Rearrangements	1

Condition MeSH

Condition MeSH for RIABNI
Intervention	Trials
Leukemia	5
Lymphoma	4
Leukemia, Lymphoid	4
Leukemia, Lymphocytic, Chronic, B-Cell	3

Clinical Trial Locations for RIABNI

Trials by Country

Trials by Country for RIABNI
Location	Trials
United States	14
Japan	2

Trials by US State

Trials by US State for RIABNI
Location	Trials
California	2
New York	2
Nebraska	1
Minnesota	1
Michigan	1

Clinical Trial Progress for RIABNI

Clinical Trial Phase

Clinical Trial Phase for RIABNI
Clinical Trial Phase	Trials
Phase 3	4
Phase 2	2
Phase 1/Phase 2	1

Clinical Trial Status

Clinical Trial Status for RIABNI
Clinical Trial Phase	Trials
Not yet recruiting	4
Recruiting	4

Clinical Trial Sponsors for RIABNI

Sponsor Name

Sponsor Name for RIABNI
Sponsor	Trials
Loxo Oncology, Inc.	2
Fate Therapeutics	1
ITB-Med LLC	1

Sponsor Type

Sponsor Type for RIABNI
Sponsor	Trials
Industry	6
Other	5
NIH	1

Clinical Trials Update, Market Analysis, and Projection for RIABNI

Last updated: November 11, 2025

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Introduction

RIABNI (rituximab-abbs) is a biosimilar monoclonal antibody developed as an alternative to the innovator biologic Rituxan (rituximab), originally marketed by Genentech/Roche. As a biosimilar, RIABNI aims to offer comparable efficacy and safety at a lower cost, expanding accessibility to treatment for various hematologic and oncologic indications. This article provides a comprehensive update on RIABNI’s clinical trials, analyzes its market landscape, and offers future projections based on current trends.

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Clinical Trials Update

Regulatory Approval and Clinical Development Milestones

Initially, RIABNI received FDA approval in August 2020 for specific oncologic and autoimmune indications, notably non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia (CLL), and rheumatoid arthritis, marking its entry into the U.S. biosimilar market [1]. The approval followed rigorous comparison trials demonstrating biosimilarity to Rituxan, including:

• Phase 1: Pharmacokinetics (PK) and pharmacodynamics (PD) studies showing comparable bioavailability, safety, and immunogenicity profiles.
• Phase 3: Pivotal trials comparing RIABNI to the reference product in indications such as follicular lymphoma, with equivalence margins met or exceeded.

Recent Clinical Investigations

Post-approval, ongoing trials focus on expanding RIABNI’s indications and monitoring long-term safety. Notably:

• Real-world evidence (RWE) studies examining its performance in community oncology settings.
• Expanded access programs across Europe and Asia to evaluate broader efficacy and safety data.
• Comparative studies assessing immunogenicity and adverse event profiles relative to the original biologic, especially pertinent for biosimilar acceptance.

Despite the pipeline’s maturity, no significant new Phase 3 studies are currently underway, indicating a focus on post-market surveillance. However, sponsors have launched observational studies to assess immunogenicity and long-term efficacy, valuable for clinicians and regulators.

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Market Analysis

Current Market Landscape

The global rituximab market, estimated at approximately USD 6 billion in 2022 [2], is witnessing rapid expansion driven by biosimilar entrants like RIABNI. Biosimilars have gained substantial traction in regions with cost-sensitive healthcare systems, notably Europe, Japan, and emerging markets.

U.S. Market Dynamics:
RIABNI faces competition from biosimilars such as Pfizer’s Ruxience and Sandoz’s Ruxience, along with the innovator Rituxan. Insurance coverage, formulary inclusion, and physician adoption significantly influence market penetration. As of 2023, biosimilar prescriptions account for roughly 35% of rituximab usage in the U.S., with expectations to grow annually [3].

European and Asian Markets:
In Europe, biosimilar penetration exceeds 50%, driven by aggressive price competition and government policies favoring cost-effective biologics. Asian markets present substantial growth opportunities due to expanding healthcare infrastructure and increased adoption of biosimilars.

Market Drivers and Barriers

Drivers:

• Cost savings: Biosimilars typically reduce treatment costs by 20-35%, fostering increased access.
• Regulatory pathways: Streamlined approval processes in major markets accelerate market entry.
• Physician acceptance: Growing confidence due to extensive biosimilar data.

Barriers:

• Physician and patient hesitancy owing to perceived efficacy disparities.
• Patent and exclusivity barriers delaying broader biosimilar adoption.
• Limited long-term comparative data, affecting confidence among prescribers.

Strategic Positioning and Commercial Efforts

Manufacturers of RIABNI leverage multiple strategies:

• Pricing strategies to optimize competitiveness.
• Educational campaigns targeting healthcare providers.
• Partnerships with healthcare systems and payers to facilitate formulary placement.

Efforts are also underway to secure broader approval in additional indications, such as autoimmune diseases like multiple sclerosis and vasculitis, aiming to diversify revenue streams.

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Market Projection and Future Outlook

Short-Term (Next 1-2 Years)

Market penetration for RIABNI is expected to increase steadily, particularly in the U.S. and Europe. The expanding biosimilar landscape will intensify competition, emphasizing the importance of differentiated marketing and value demonstration. Adoption barriers will gradually diminish as more long-term data becomes available, increasing clinician confidence.

Medium to Long-Term (3-5 Years)

Projections indicate that biosimilars like RIABNI will command approximately 60-70% of rituximab prescriptions worldwide by 2025, driven by sustained cost benefits and expanding indications [4]. Specifically:

• In hematological cancers, biosimilar uptake will accelerate, fueled by hospital formularies and payer preferences.
• In autoimmune indications, increased off-label and approved uses will boost sales.
• Strategic alliances with global pharmaceutical distributors will enhance access in emerging markets.

Risks and Opportunities

While the biosimilar market presents growth opportunities, challenges such as regulatory hurdles, anti-biosimilar litigation, and hospital procurement complexities persist. However, the ongoing global push for affordable biologics positions RIABNI favorably for long-term growth.

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Concluding Remarks

RIABNI’s clinical trial history underscores its biosimilarity to the original rituximab, complemented by a growing body of real-world data. Its market trajectory is promising, supported by favorable economic drivers and expanding indications, although competitive pressures remain formidable. Manufacturers’ ability to strengthen clinical evidence, foster clinician confidence, and navigate regulatory landscapes will be critical for market share expansion.

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Key Takeaways

• RIABNI has successfully completed pivotal trials and received regulatory approval in the U.S., with ongoing post-market studies to reinforce its safety and efficacy profile.
• The biosimilar market for rituximab is expanding globally, reaching high penetration levels, especially in Europe and Asia, with ample growth potential in the U.S.
• Price competitiveness, clinician acceptance, and indication expansion will heavily influence RIABNI’s market share advancement.
• Long-term growth hinges on comprehensive clinical data, strategic partnerships, and adaptability in regulatory and reimbursement environments.
• The biosimilar sector’s trajectory suggests RIABNI will become a significant player in hematology and autoimmune therapeutic areas within three to five years.

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FAQs

1. What are the primary indications approved for RIABNI?
RIABNI is approved for non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, and rheumatoid arthritis, aligning with the indications of the reference rituximab.

2. How does RIABNI compare in efficacy and safety to the original Rituxan?
Clinical trials demonstrate biosimilarity in efficacy, safety, and immunogenicity, with comparable adverse event profiles and pharmacologic performance.

3. What are key barriers to RIABNI’s wider adoption?
Barriers include clinician skepticism, patent litigation, limited long-term comparative data, and reimbursement uncertainties.

4. How significant is the role of biosimilars like RIABNI in reducing healthcare costs?
Biosimilars can reduce biologic treatment costs by 20-35%, substantially improving patient access and lowering healthcare expenditures.

5. What strategies could enhance RIABNI’s market penetration?
Effective strategies include demonstrating long-term comparative effectiveness, fostering clinician education, engaging payers, and expanding indications globally.

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References

[1] FDA Approval Announcement. (2020). U.S. Food & Drug Administration.
[2] Market Research Future. (2022). Global Rituximab Market Analysis.
[3] IQVIA. (2023). Biosimilar Adoption Trends in the U.S.
[4] Evaluate Pharma. (2022). Biosimilar Market Forecasts.