Riabni (rituximab-arrx) / Amgen, AbbVie - LARVOL DELTA

Multimodal mass spectrometric characterization of structural microheterogeneity in rituximab reference and biosimilars. (PubMed, Int J Biol Macromol) - "Three biosimilars to Rituxan® (rituximab)-Truxima®, Ruxience®, and Riabni™-have received FDA approval. Since commercially available biosimilars were analyzed, the observed variations reflect real-world analytical variability that does not impact clinical performance. These findings, which offer detailed analytical comparisons of biosimilars, provide insights into acceptable structural variation and support efforts to refine regulatory assessment practices."

Journal

Celltrion’s Rituxan biosimilar wins rare disease nod as Pfizer, Amgen land same-day OKs (Korea Biomedical Review) - "Celltrion just checked off a major box in its race to match Roche’s Rituxan (rituximab). On Wednesday U.S. time, the FDA approved Truxima for use in moderate to severe pemphigus vulgaris (PV), a rare autoimmune blistering disease, granting the Korean biosimilar maker its fifth adult indication for the CD20-targeting therapy....But Celltrion wasn’t the only winner. Pfizer and Amgen also scored approvals the same day for their Rituxan biosimilars, Ruxience and Riabni, respectively, in the PV indication."

FDA approval • Pemphigus Vulgaris

Occlusive Vasculitis Following Intravitreal Rituximab Injection for Primary Vitreoretinal Lymphoma. (PubMed, Ocul Immunol Inflamm) - "We report three cases of occlusive vasculitis following intravitreal rituximab therapy for biopsy-proven primary vitreoretinal lymphoma (PVRL), one of which was following an injection of the biosimilar Riabni (rituximab-arrx, AmGen) and two of which were following an injection of Rituxan (rituximab, Genentech). Occlusive vasculitis is a rarely reported but potential complication of intravitreal rituximab therapy in patients who have been previously treated with the agent and may have delayed onset. A low threshold for fluorescein angiography as a diagnostic test for post-injection vision loss and prompt treatment with topical and/or oral steroids should be considered."

Journal • CNS Lymphoma • Hematological Malignancies • Lymphoma • Ocular Inflammation • Oncology • Ophthalmology • Uveitis • Vasculitis

Uptake and Costs of Rituximab Biosimilars Among the Medicare and Medicaid Populations in 2019-2021 in the United States (ISPOR 2024) - "This exploratory study evaluated the uptake and costs of three biosimilars rituximab-abbs (Truxima®), rituximab-pvvr (Ruxience®), and rituximab-arrx (Riabni®) among the Medicare and Medicaid populations in 2019-2021. Significant uptake of rituximab biosimilars in Medicare and Medicaid programs occurred within the first 3 years of marketing in the U.S."

Clinical • Medicaid • Medicare • Reimbursement • US reimbursement • Immunology • Oncology

Rituximab reference vs biosimilar utilization for oncology vs nononcology indications. (PubMed, Am J Manag Care) - "Real-world evidence shows an increase in rituximab biosimilar adoption over time, with higher adoption for oncology vs nononcology indications and in nonacademic settings."

Journal • Oncology

Ublituximab (Briumvi) for relapsing multiple sclerosis. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • CNS Disorders • Multiple Sclerosis

Comparison of Adverse Event Profiles of Rituximab, Rituximab Hycela and Rituximab Biosimilars: A Real-World Pharmacovigilance Database Analysis (ASH 2022) - "Rituximab-abbs had the lowest odds of causing respiratory (ROR 3.34, 2.90-3.85), skin (ROR 4.80, 4.15-5.55) and immune-related events (ROR 1.76, 1.40-2.22) compared to other biosimilars and rituximab/Rituxan. Additional reporting on Rituximab-pvvr and Rituximab-arrx should also exhibit lower reaction rates as compared to Rituximab. Large scale clinical trials are necessary to establish if there is a real difference in ADR rates between different rituximab products."

Adverse events • Clinical • Real-world evidence • Allergy • Dermatology • Hematological Disorders • ROR1

A review of the totality of evidence in the development of ABP 798, a rituximab biosimilar. (PubMed, Immunotherapy) - "Comparative clinical efficacy and safety of ABP 798 with rituximab RP was demonstrated as a final step in patients with non-Hodgkin lymphoma and in those with rheumatoid arthritis. Overall, the totality of evidence supported the conclusion that ABP 798 is highly similar to rituximab RP and provided scientific justification for extrapolation to other approved indications of rituximab RP."

Journal • Review • Hematological Malignancies • Immunology • Inflammatory Arthritis • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Rheumatoid Arthritis • Rheumatology

Expanded Table: Some biologic drugs and JAK inhibitors for rheumatoid arthritis. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Non-clinical similarity of biosimilar ABP 798 with rituximab reference product. (PubMed, Biologicals) - "Additionally, in vitro synergy of ABP 798 or RP with chemotherapeutic agents, in vivo xenograft studies in mice, and toxicological assessments in cynomolgus monkeys (including B cell depletion and toxicokinetics) were also conducted. Results from these non-clinical assessments contribute to the TOE supporting the biosimilarity between ABP 798 and rituximab RP across a range of primary and secondary MOAs and support justification for extrapolation to all indications of use for ABP 798 for which the RP is approved."

Clinical • Journal • CD20

Canada approves rituximab biosimilar Riabni (GaBI) - "Canada’s drug regulator, Health Canada, has approved the rituximab biosimilar Riabni for the treatment of rheumatoid arthritis as well as chronic lymphocytic leukaemia and non-Hodgkin’s lymphoma."

Canadian regulatory • Chronic Lymphocytic Leukemia • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology • Rheumatoid Arthritis

MARKUS @ HOMe INTERNATIONAL - Membranous Nephropathy - Dr. Fervenza (Rochester) (YouTube) - "Dr. Fernando Fervenza discusses pathophysiology, diagnosis and treatment of membranous nephropathy. Dr. Fervenza is the lead investigator of the MENTOR study, which is the pivotal randomized trial that studied rituximab in membranous nephropathy, and he is co-author of the 2021 KDIGO guidelines on glomerulonephritis."

Video

Nivolumab and Combination Chemotherapy in Treating Participants With Diffuse Large B-Cell Lymphoma (clinicaltrials.gov) - P1/2; N=30; Recruiting; Sponsor: Northwestern University; Trial completion date: Jun 2022 ➔ Jun 2023; Trial primary completion date: May 2021 ➔ May 2022

Clinical • Combination therapy • Trial completion date • Trial primary completion date • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Cell Histiocyte Rich Large B Cell Lymphoma • T Cell Non-Hodgkin Lymphoma • CD20

PACIFIC: Primary Mediastinal Large B-cell Lymphoma Treated With Antibody Therapy, Checkpoint Inhibitor in Frontline With ImmunoChemotherapy (clinicaltrials.gov) - P2; N=40; Recruiting; Sponsor: M.D. Anderson Cancer Center; Not yet recruiting ➔ Recruiting

Checkpoint inhibition • Clinical • Enrollment open • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • TNFRSF8

Drugs for multiple sclerosis. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • CNS Disorders • Multiple Sclerosis

High-Dose Y-90-Ibritumomab Tiuxetan Added to Reduced-Intensity Allogeneic Stem Cell Transplant Regimen for Relapsed or Refractory Aggressive B-Cell Lymphoma (clinicaltrials.gov) - P2; N=20; Terminated; Sponsor: Fred Hutchinson Cancer Research Center; Active, not recruiting ➔ Terminated; Terminated due to insufficient funding

Clinical • Trial termination • Bone Marrow Transplantation • Burkitt Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Transplantation • CD20

Clofarabine, Idarubicin, Cytarabine, Vincristine Sulfate, and Dexamethasone in Treating Patients With Newly Diagnosed or Relapsed Mixed Phenotype Acute Leukemia (clinicaltrials.gov) - P2; N=60; Recruiting; Sponsor: M.D. Anderson Cancer Center; Trial completion date: Oct 2020 ➔ Dec 2034; Trial primary completion date: Oct 2020 ➔ Dec 2034

Clinical • Trial completion date • Trial primary completion date • Hematological Malignancies • Leukemia • Oncology

Inotuzumab Ozogamicin and Chemotherapy in Treating Patients With Leukemia or Lymphoma Undergoing Stem Cell Transplantation (clinicaltrials.gov) - P2; N=44; Recruiting; Sponsor: M.D. Anderson Cancer Center; Trial completion date: Mar 2021 ➔ Mar 2025; Trial primary completion date: Mar 2021 ➔ Mar 2025

Clinical • Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Leukemia • Lymphoma • Oncology • Transplantation • CD22 • HLA-DRB1

Combination Chemotherapy and TAK-659 as Front-Line Treatment in Treating Patients With High-Risk Diffuse Large B Cell Lymphoma (clinicaltrials.gov) - P1; N=12; Active, not recruiting; Sponsor: Northwestern University; Recruiting ➔ Active, not recruiting; N=18 ➔ 12

Clinical • Enrollment change • Enrollment closed • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Indolent Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Cell Histiocyte Rich Large B Cell Lymphoma • BCL2 • BCL6 • MYC

Venetoclax, Dasatinib, Prednisone, and Rituximab for the Treatment of Newly Diagnosed or Relapsed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P1; N=20; Not yet recruiting; Sponsor: OHSU Knight Cancer Institute; Initiation date: May 2021 ➔ Aug 2021

Clinical • Combination therapy • Trial initiation date • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology

Ibrutinib With or Without Rituximab in Treating Patients With Relapsed Chronic Lymphocytic Leukemia (clinicaltrials.gov) - P2; N=208; Active, not recruiting; Sponsor: M.D. Anderson Cancer Center; Trial completion date: Dec 2020 ➔ Dec 2021; Trial primary completion date: Dec 2020 ➔ Dec 2021

Clinical • Trial completion date • Trial primary completion date • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Prolymphocytic Leukemia • Small Lymphocytic Lymphoma

Bendamustine and Rituximab in Combination With Copanlisib for the Treatment of Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (clinicaltrials.gov) - P2; N=25; Suspended; Sponsor: University of Washington; Recruiting ➔ Suspended

Combination therapy • Trial suspension • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma

Ibrutinib, Rituximab, Etoposide, Prednisone, Vincristine Sulfate, Cyclophosphamide, and Doxorubicin Hydrochloride in Treating Patients With HIV-Positive Stage II-IV Diffuse Large B-Cell Lymphomas (clinicaltrials.gov) - P1; N=54; Not yet recruiting; Sponsor: National Cancer Institute (NCI)

Clinical • New P1 trial • Diffuse Large B Cell Lymphoma • Human Immunodeficiency Virus • Infectious Disease • CD20 • CD4

Ibrutinib, Rituximab, Etoposide, Prednisone, Vincristine Sulfate, Cyclophosphamide, and Doxorubicin Hydrochloride in Treating Patients With HIV-Positive Stage II-IV Diffuse Large B-Cell Lymphomas (clinicaltrials.gov) - P1; N=54; Not yet recruiting; Sponsor: National Cancer Institute (NCI); Trial completion date: Sep 2020 ➔ Jul 2023; Trial primary completion date: Sep 2020 ➔ Jul 2023

Clinical • Trial completion date • Trial primary completion date • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Human Immunodeficiency Virus • Infectious Disease • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20 • CD4

Ibrutinib, Rituximab, Etoposide, Prednisone, Vincristine Sulfate, Cyclophosphamide, and Doxorubicin Hydrochloride in Treating Patients With HIV-Positive Stage II-IV Diffuse Large B-Cell Lymphomas (clinicaltrials.gov) - P1; N=54; Recruiting; Sponsor: National Cancer Institute (NCI); Not yet recruiting ➔ Recruiting; Trial primary completion date: Jul 2023 ➔ Sep 2021

Clinical • Enrollment open • Trial primary completion date • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Human Immunodeficiency Virus • Infectious Disease • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20 • CD4