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.
NCT05600686 ↗	Loncastuximab Tesirine and Rituximab Followed by DA-EPOCH-R for Treating Patients With High-Risk Diffuse Large B-cell Lymphoma	Not yet recruiting	ADC Therapeutics	Phase 2	2022-12-01	This phase II trial evaluates whether loncastuximab tesirine and rituximab followed by dose-adjusted doxorubicin, etoposide, vincristine, cyclophosphamide, and prednisone works to treat patients with high risk diffuse large B-cell lymphoma. Loncastuximab tesirine is a monoclonal antibody called loncastuximab, linked to a drug called tesirine. It is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD19 receptors, and delivers tesirine to kill them. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Chemotherapy drugs such as doxorubicin, vincristine, and cyclophosphamide 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. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair and may kill cancer cells. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Giving loncastuximab tesirine and rituximab in combination with dose-adjusted doxorubicin, etoposide, vincristine, cyclophosphamide, and prednisone may be more effective at treating high risk diffuse large B-cell lymphoma patients than standard treatments.
NCT05600686 ↗	Loncastuximab Tesirine and Rituximab Followed by DA-EPOCH-R for Treating Patients With High-Risk Diffuse Large B-cell Lymphoma	Not yet recruiting	National Cancer Institute (NCI)	Phase 2	2022-12-01	This phase II trial evaluates whether loncastuximab tesirine and rituximab followed by dose-adjusted doxorubicin, etoposide, vincristine, cyclophosphamide, and prednisone works to treat patients with high risk diffuse large B-cell lymphoma. Loncastuximab tesirine is a monoclonal antibody called loncastuximab, linked to a drug called tesirine. It is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD19 receptors, and delivers tesirine to kill them. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Chemotherapy drugs such as doxorubicin, vincristine, and cyclophosphamide 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. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair and may kill cancer cells. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Giving loncastuximab tesirine and rituximab in combination with dose-adjusted doxorubicin, etoposide, vincristine, cyclophosphamide, and prednisone may be more effective at treating high risk diffuse large B-cell lymphoma patients than standard treatments.

Clinical Trial Conditions for RIABNI

Condition Name

Condition Name for RIABNI
Intervention	Trials
Chronic Lymphocytic Leukemia	3
Small Lymphocytic Lymphoma	2
Anemia, Sickle Cell	1
B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative	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
Texas	1
Oklahoma	1
Nebraska	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
Recruiting	4
Not yet recruiting	4

Clinical Trial Sponsors for RIABNI

Sponsor Name

Sponsor Name for RIABNI
Sponsor	Trials
Loxo Oncology, Inc.	2
Incyte Corporation	1
University of Washington	1

Sponsor Type

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

RIABNI (infliximab-abda) clinical trials update, market analysis and 2026-2031 projection

Last updated: May 17, 2026

Executive summary

• RIABNI (infliximab-abda) is the infliximab biosimilar to Remicade (infliximab) marketed by Samsung Bioepis for the US market and by other partners in additional geographies.
• Clinical development for RIABNI has already established biosimilarity to Remicade via comparative efficacy and safety (notably across rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis), with post-approval use and ongoing studies focused on switching, real-world performance, and product lifecycle activities rather than new pivotal efficacy programs.
• Market sizing and projections depend on uptake versus Remicade and other infliximab biosimilars, center-of-excellence prescribing patterns, payer contracting, and biologic interchange policy. Near-term growth is driven by continued conversion from originator and price pressure; mid-term growth is capped by penetration limits in established markets and by competitive share loss to other infliximab biosimilars.

What is RIABNI (infliximab-abda) and what clinical evidence supports it?

Fast answer RIABNI is an infliximab biosimilar (TNF-alpha inhibitor) approved for multiple immune-mediated inflammatory diseases and supported by a biosimilar totality-of-evidence package including PK/PD similarity, immunogenicity characterization, and at least one pivotal comparative efficacy study in which clinical endpoints matched the reference product.

Which indications is RIABNI approved for in the US?

RIABNI’s US prescribing information lists indications consistent with Remicade, including:

• Rheumatoid arthritis (with methotrexate)
• Ankylosing spondylitis
• Psoriatic arthritis
• Crohn’s disease
• Ulcerative colitis

What clinical trials established biosimilarity for RIABNI?

The clinical package used in approval centers on:

• Comparative pharmacokinetics (infliximab exposure similarity)
• Comparative efficacy versus Remicade in at least one pivotal indication
• Comparative safety and immunogenicity
• Switching and ongoing immunogenicity monitoring in the post-approval landscape

How do immunogenicity and safety profiles affect uptake?

For infliximab biosimilars, payer and clinician adoption depends on:

• Infusion reaction rates
• Anti-drug antibody incidence and impact on trough levels
• Loss of response patterns relative to originator
• Real-world persistence (continuation rates on therapy)

What is the latest clinical trials update for RIABNI in 2024-2026?

Fast answer No new class-defining pivotal trials are typically required after biosimilar licensure; therefore, updates generally appear as:

• Postmarketing studies and registry analyses
• Additional observational cohorts for persistence and switching outcomes
• Studies in special populations (pediatrics, pregnancy, elderly) and formulation/manufacturing lifecycle work, depending on regulatory commitments

How to interpret “clinical trials updates” for an already-licensed biosimilar

For RIABNI, trial updates that move the adoption curve usually focus on:

• “Switching” outcomes (immunogenicity after interchange)
• Drug durability (time to discontinuation)
• Real-world effectiveness across community sites, not just academic centers
• Subgroup outcomes in Crohn’s and ulcerative colitis, where infliximab is frequently managed with therapeutic drug monitoring

How large is the infliximab market and where does RIABNI fit?

Fast answer RIABNI competes in a crowded infliximab biosimilar segment where total addressable spend is driven by:

• Crohn’s disease and ulcerative colitis biologic adoption and persistence
• Rheumatoid and spondyloarthropathy treated with infliximab in patients needing high disease control
• The economics of biosimilar contracting, infusion-center formulary decisions, and pharmacy benefit design

Key drivers of RIABNI demand

• Contracted biosimilar penetration replacing Remicade in hospital and integrated delivery networks
• Therapeutic drug monitoring integration and continuation management
• Switching protocols and payer policies on interchange
• Manufacturer distribution capacity and cold-chain execution reliability

Key constraints on RIABNI growth

• Competitive price pressure from multiple infliximab biosimilars
• Originator rebates that can narrow price gaps during tender cycles
• Brand-based and infusion-center inertia, particularly for non-IBD indications

RIABNI market share: what is the competitive landscape for infliximab biosimilars?

Fast answer RIABNI competes against other infliximab biosimilars in the US, with share outcomes determined by:

• Tender cycle timing
• Net price after rebates
• Institutional switching policies
• Clinician familiarity and pharmacy interchange rules

Competitive set

Infliximab biosimilar competitors in the US include:

• Inflectra (infliximab-dyyb) by Pfizer
• Renflexis (infliximab-abda, note: infliximab-abda is the originator-like active name used for products depending on label; distinct product codes exist across companies)
• Avsola (infliximab-axxq) by Amgen

(Actual RIABNI share by NDC and geography requires payer and IQVIA/claims datasets not provided in this request.)

How much revenue growth can RIABNI capture in 2026-2031?

Fast answer RIABNI’s 2026-2031 trajectory is best modeled as share expansion within the biosimilar infliximab segment, bounded by:

• Saturation of originator conversion
• Ongoing tender-driven share rotations among biosimilars
• Net price declines as contracting intensifies

Projection framework (scenario-based, drivers only)

Because specific RIABNI unit share and net price are not provided here, a defensible projection relies on structural drivers:

• Baseline: current biosimilar penetration in each indication and channel (hospital outpatient infusion vs specialty pharmacy)
• Conversion: rate at which Remicade patients are switched to biosimilars under payer and provider policies
• Switching persistence: continuation rates after interchange, which determine net units and margin
• Price: expected further net price compression due to competitive tendering

Indicative projection ranges (requires input data to be made precise)

A practical planning range for biosimilar infliximab growth in established markets is often low-to-mid single-digit volume growth annually, with revenue influenced more by net price than by volume after high penetration is reached. RIABNI’s incremental performance versus competitors typically follows contract wins and regional formulary changes.

When does RIABNI face competitive share erosion, and what are the risk points?

Fast answer The risk of share erosion increases when:

• Multi-biosimilar contracting shifts to single-preferred strategies during tender cycles
• Net price gaps widen due to more aggressive rebate structures by competitors
• Clinical pathways shift toward alternative biologics (IL-23, JAK, other mechanisms) in IBD, reducing infliximab initiation rates

Most material risk points for RIABNI

• Loss of “preferred biosimilar” status in high-volume centers
• Higher-than-peer immunogenicity or persistence differences in real-world cohorts
• Formulary restrictions in non-IBD indications where prescribers have switching hesitation

What is the FDA and Orange Book status of RIABNI?

Fast answer As a licensed biologic, RIABNI is not listed in the FDA’s Orange Book (which is for small-molecule drugs and certain biologics that may appear in specific contexts). Instead, biosimilar information is tracked via the Biologics Price Competition and Innovation Act (BPCIA) regulatory framework, product labeling, and FDA biosimilar designations.

What to monitor for regulatory lifecycle changes

• Label updates related to postmarketing commitments
• Additional postmarketing safety surveillance obligations
• Manufacturing changes and comparability protocols
• Interchange-related communications where applicable in practice, though interchange policy is state/payer driven

What biosimilar interchange and switching evidence matters for RIABNI adoption?

Fast answer Switching evidence matters most because immunogenicity and drug durability drive continuation, which drives long-term spend.

What endpoints predict successful switching?

• Anti-drug antibody development rates after switching
• Maintenance of trough drug levels
• Clinical remission/response stability post-switch
• Infusion reaction and hypersensitivity rates
• Treatment persistence at 6, 12, and 24 months

How does RIABNI compare with Remicade and other infliximab biosimilars on clinical and operational factors?

Fast answer Clinically, biosimilars target demonstrated similarity in PK exposure, efficacy, safety, and immunogenicity. Operationally, differentiation emerges from:

• Contracting and net price
• Supply reliability
• Center-specific administration protocols and switching workflows

Comparison dimensions that influence procurement

• Net price and rebate structures
• Supply allocation and lead-time stability
• Patient support programs (prior auth, infusion scheduling)
• Compatibility with therapeutic drug monitoring workflows

What patent landscape considerations affect RIABNI market durability?

Fast answer Biosimilar market duration is mostly governed by:

• Reference product biologic patent estate (Remicade) and any lingering IP around specific formulations, methods, or delivery systems
• Biosimilar regulatory exclusivities at launch and any later lifecycle exclusivities tied to new indications (if any)

Why patent specifics often matter less for RIABNI post-launch

Once biosimilar approval is granted under BPCIA and reference product patents are no longer barrier-level for commercial marketing, further growth tends to rely on competitive contracting rather than legal restrictions.

Key takeaways

• RIABNI is an established infliximab biosimilar across multiple inflammatory diseases, with adoption driven by switching outcomes, persistence, and contracting rather than new pivotal efficacy trials.
• Market growth through 2026-2031 is primarily a function of continued originator conversion, competitive tender dynamics among infliximab biosimilars, and IBD biologic treatment mix shifts.
• The most important commercial risks for RIABNI are share erosion during payer/provider tender cycles and competitive net price compression by other infliximab biosimilars.

FAQs

1. What clinical endpoints are most predictive of long-term persistence for infliximab biosimilars like RIABNI?
2. How do tender cycles and hospital formulary rules change RIABNI uptake across US regions?
3. What are the main drivers of immunogenicity risk in infliximab switching, and how do they impact payer policy?
4. How is RIABNI affected by IBD treatment substitution trends toward IL-23 and JAK inhibitors?
5. What operational factors beyond clinical equivalence influence whether infusion centers prefer RIABNI over competing infliximab biosimilars?

References

1. U.S. Food and Drug Administration. RIABNI (infliximab-abda) prescribing information and labeling.
2. FDA. BPCIA biosimilar regulatory framework and FDA guidance documents.
3. Published peer-reviewed biosimilar evidence comparing infliximab biosimilars to Remicade across approved indications.