Ruxience (rituximab-pvvr) / Pfizer - LARVOL DELTA

Effectiveness and safety of rituximab-pvvr versus originator rituximab for rheumatoid arthritis in the veterans health administration. (PubMed, Rheumatology (Oxford)) - "We found no clinically meaningful differences in the effectiveness or safety of rituximab-pvvr compared with originator rituximab among incident users with RA. These real-world findings support the clinical use of rituximab-pvvr and may improve clinician and patient confidence in biosimilar adoption."

Journal • Immunology • Infectious Disease • Inflammatory Arthritis • Oncology • Rheumatoid Arthritis • Rheumatology

19-C-0042: Moxetumomab Pasudotox-tdfk (Lumoxiti(TM)) and Either Rituximab (Rituxan(R)) or Ruxience for Relapsed Hairy Cell Leukemia (clinicaltrials.gov) - P1 | N=18 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Jun 2026 ➔ Jun 2029

Trial completion date • Hairy Cell Leukemia • Hematological Malignancies • Leukemia • Oncology

Real-world resource use and cost in patients treated with originator or biosimilar rituximab in a large U.S. insurance claims database. (ASCO 2026) - "Funded by Pfizer Background: Rituximab-pvvr, Rituximab-arrx, and Rituximab-abbs are monoclonal antibodies approved by the FDA as biosimilars to originator rituximab. In this large real-world cohort of NHL and CLL patients, resource use was similar in patients treated with originator and biosimilar rituximab, but medications costs were significantly lower in the biosimilar groups. Our findings demonstrate how biosimilar therapies in cancer can deliver similar clinical outcomes to originators, while generating meaningful cost savings for the U.S. healthcare system. *Includes all medications paid under medical benefit, including rituximab."

Claims database • Clinical • Real-world • Real-world evidence • Reimbursement • US reimbursement • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma

Intravenous DTX301 Redosing in Mice Treated with Transient B Cell-Directed Immunomodulation (ASGCT 2026) - "Our previous work demonstrated that B cell-directed immunomodulation (IM) with prednisolone/rapamycin/rituximab-pvvr administered alongside AAV gene therapy reduced (but did not eliminate) anti-capsid antibody formation in nonhuman primates. Conclusion A transient, B cell-directed immunomodulation regimen using the Biswas protocol of anti- mCD20 and extended anti-mBAFF effectively depleted circulating B cells, reduced anti-AAV IgM and IgG formation, and enabled liver-directed AAV redosing in a subset of animals. Importantly, successful redosing was achieved using the same AAV gene therapy vector at clinically relevant doses."

Immunomodulating • Preclinical • Gene Therapies • Immunology

19-C-0042: Moxetumomab Pasudotox-tdfk (Lumoxiti(TM)) and Either Rituximab (Rituxan(R)) or Ruxience for Relapsed Hairy Cell Leukemia (clinicaltrials.gov) - P1 | N=18 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Jun 2025 ➔ Jun 2026

Trial completion date • Hairy Cell Leukemia • Hematological Malignancies • Leukemia • Oncology

EMPIRICAL TIME-SERIES ANALYSES IN THE PAST THREE DECADES 1991-2023 FOR IMMUNE THROMBOCYTOPENIA MEDICATIONS IN THE US MEDICAID PROGRAMS (ISPOR 2026) - "Study medications target platelet count restoration and immune system modulation, including thrombopoietin receptor agonists (TPO-RA), such as Nplate (Romiplostim) and Promacta (Eltrombopag), and IV immunoglobulin (e.g., Gammagard) or anti-D immunoglobulin, Rituximab (an anti-CD20 monoclonal antibody), and newer Tyrosine kinase inhibitors...Comparative market-share analyses were also conducted within and across therapeutic classes Utilization trends revealed Rituxan dominated until 2020, after which biosimilars (Ruxience, Truxima) gained traction, with Ruxience leading. In the IVIG category, Gammagard consistently held the highest utilization, peaking in 2022, followed by Rhophylac and Privigen...Pricing data highlighted Promacta as the most expensive TPO-RA, while Panzyga led IVIG pricing by 2019... Analysis highlights evolving patterns in the utilization, reimbursement, and pricing of ITP therapies within Medicaid programs, shaped by factors such as the introduction of..."

Medicaid • Reimbursement • US reimbursement • Hematological Disorders • Immune Thrombocytopenic Purpura • Thrombocytopenia • Thrombocytopenic Purpura

Infusion Reactions with Rituximab Originator and Its Biosimilars Used to Treat Renal Disorders (NKF-SCM 2026) - "6 received the originator (Rituxan®), 7 received biosimilars (6 Ruxience® and 1 Riabni®), and 3 received both (Rituxan® & Ruxience®)...2 patients in each group were also on Mycophenolate mofetil (MMF), 1 in the originator group was on tacrolimus, and 1 in the biosimilar group received MMF, tacrolimus, and Cytoxan...CONCLUSION In this small cohort, infusion reactions were mild and similar in both the originator and biosimilar groups. Larger studies are needed to further evaluate the safety and efficacy of rituximab biosimilars in clinical practice."

Immunology • Nephrology • Renal Disease

Cost-efficiency modeling of conversion to biosimilar rituximab-based R-CHOP in diffuse large B-cell lymphoma in medicare. (PubMed, J Med Econ) - "Rituximab-pvvr (Ruxience), -abbs (Truxima), and -arrx (Riabni) are biologic therapies approved by the United States Food and Drug Administration (FDA) as biosimilars to originator rituximab (Rituxan). Each is approved for the treatment of diffuse large B-cell lymphoma (DLBCL) in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP)...In this first cost-efficiency and expanded access study of biosimilar rituximab in DLBCL in Medicare, we find that conversion to biosimilar-based R-CHOP can result in substantial cost savings relative to originator-based R-CHOP. These biosimilar-associated cost savings could be reinvested to treat thousands of additional DLBCL patients or fund other costs of care in Medicare, on a budget-neutral basis."

Journal • Medicare • Reimbursement • US reimbursement • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Differences in insurer payments for hematology part B drugs between traditional Medicare and Medicare advantage (ASH 2025) - "Thelargest relative payment differences were observed for rituximab-pvvr (34.4% higher in MedicareAdvantage; 95% CI, 26.5% to 42.4%; p < 0.001), elotuzumab (31.4% higher in Medicare Advantage; 95% CI,0.1% to 62.8%; p < 0.001), and rituximab-abbs (31.4% higher in Medicare Advantage; 95% CI, 20.6% to42.2%; p < 0.001). Payment differences were the most similar between traditional Medicare and MedicareAdvantage for rituximab (3.1% higher in Medicare Advantage; 95% CI, -2.4% to 8.7%; p < 0.001) anddaratumumab (8.2% higher in Medicare Advantage; 95% CI, 0.6% to 15.8%; p < 0.001). While payments in traditional Medicare are well established, negotiated payments inMedicare Advantage are unknown and have implications for patient affordability and physician payment.We find that each drug in our sample is paid at a higher rate in Medicare Advantage than traditionalMedicare, suggesting that Medicare Advantage beneficiaries may be responsible for greater..."

Medicare • Reimbursement • US reimbursement • Hematological Disorders

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

Rituximab Reduces Immunogenicity and Increases Complete Remissions without Minimal Residual Disease in Relapsed/Refractory Hairy Cell Leukemia Patients Receiving Moxetumomab Pasudotox (ASH 2024) - "Patients 14-18 received the biosimilar Ruxience instead of rituximab...One multiply relapsed patient with rituximab allergy was treated off-protocol with 8 cycles of Moxe plus Obinutuzumab and achieved an MRD-free CR.Conclusions : MoxeR is a safe regimen for relapsed-refractory HCL/HCLv, with the highest MRD-free CR rate reported yet for this disease...Non-Hodgkin's lymphomas (NHL), such as diffuse large B-cell, mantle cell, marginal zone, follicular, and lymphoplasmacytic lymphoma, express significant levels of CD22, and lymphoma cells from these patients have sensitivity to Moxe similar to HCL. We believe this trial supports the testing of Moxe plus anti-CD20 Mab in patients with early HCL/HCLv, and in patients with NHL to convert MRD-positive to MRD-negative CRs."

Clinical • Minimal residual disease • Residual disease • Atypical Hemolytic Uremic Syndrome • Diffuse Large B Cell Lymphoma • Hairy Cell Leukemia • Hematological Malignancies • Immunology • Leukemia • Lymphoma • Lymphoplasmacytic Lymphoma • Nephrology • Non-Hodgkin’s Lymphoma • Oncology • Waldenstrom Macroglobulinemia

A Novel Case of Cholestatic Drug-Induced Liver Injury Following Filgrastim Use in a Patient With Neutropenic Fever (ACG 2025) - "This report describes a unique case of DILI following filgrastim use in the inpatient setting.Case Description/ A 70-year-old male with Waldenström's macroglobulinemia, undergoing monthly chemotherapy with bendamustine and rituximab followed by D1 C2 Ruxience, presented three weeks after his fifth infusion, with neutropenic fever...He received 30 cc/kg of Lactated Ringer's, IV vancomycin, and cefepime. Additional antibiotics included meropenem, micafungin, and piperacillin-tazobactam...ACG Case Rep J. 2019; 6(6):e00098. doi:10.14309/crj.0000000000000098.Figure: Trends of Liver Enzymes and Total Bilirubin"

Clinical • Chemotherapy-Induced Neutropenia • Febrile Neutropenia • Hematological Disorders • Hepatology • Immunology • Liver Failure • Lymphoma • Lymphoplasmacytic Lymphoma • Neutropenia • Waldenstrom Macroglobulinemia

Effectiveness and Safety of Rituximab Biosimilars in Small Vessel Vasculitis: a Systematic Literature Review (ACR Convergence 2025) - "Most studies reported on the biosimilar Truxima (n=6), while Ruxience, Acelbia and Reditux were evaluated in one study each, and biosimilar type was not indicated in one abstract. We did not identify any randomized studies of biosimilar rituximab for small-vessel vasculitis, and observational data is limited. The biosimilars studied in AAV appear to have safety and effectiveness similar to historical randomized controlled trials and observational studies of the originator molecule."

Clinical • Review • ANCA Vasculitis • Hematological Disorders • Immunology • Infectious Disease • Neutropenia • Vasculitis

DanNORMS: Non-inferiority Study of Ocrelizumab and Rituximab in Active Multiple Sclerosis (clinicaltrials.gov) - P3 | N=600 | Active, not recruiting | Sponsor: Rigshospitalet, Denmark | Trial completion date: May 2028 ➔ May 2029

Head-to-Head • Trial completion date • CNS Disorders • Multiple Sclerosis • NEFL

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

Rituximab-pvvr and Abatacept vs Rituximab-pvvr Alone in New Onset Type 1 Diabetes (clinicaltrials.gov) - P2 | N=74 | Active, not recruiting | Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Recruiting ➔ Active, not recruiting | Trial completion date: Oct 2029 ➔ Mar 2029 | Trial primary completion date: Oct 2027 ➔ Mar 2027

Enrollment closed • Trial completion date • Trial primary completion date • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Cost-Efficiency Modeling of Conversion to Biosimilar Rituximab-pvvr in Diffuse Large B-Cell Lymphoma in Medicare (ISPOR 2025) - "These savings represent 33% and 66% reductions in cost vs. originator-based treatment, respectively, and exceed savings from alternative biosimilars rituximab-abbs or -arrx. We found that R-CHOP with rituximab-pvvr can achieve substantial cost savings relative to originator-based treatment, allowing reinvestment to treat a substantial number of additional patients with DLBCL, or fund other costs of care in Medicare, on a budget-neutral basis."

Medicare • Reimbursement • US reimbursement • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Empirical Time-Series Analysis (1991–2023) of Immune Thrombocytopenia Medications in U.S. Medicaid Programs (ISPOR 2025) - "Comparative market-share analyses were conducted across therapeutic classes to identify key drivers of market changes, including policy shifts, competition, and new drug entries The utilization trends revealed Rituxan dominated until 2020, after biosimilars (Ruxience, Truxima) gained traction, with Ruxience leading. In the IVIG category, Gammagard consistently held the highest utilization, peaking in 2022, followed by Rhophylac and Privigen. Among TPO-RAs, Promacta surpassed Nplate in 2018, reflecting a shift in prescribing patterns. Pricing data highlighted Promacta as the most expensive TPO-RA, Panzyga led IVIG pricing by 2019... This analysis highlights evolving patterns in the utilization, reimbursement, and pricing of ITP therapies within Medicaid programs, shaped by factors like the introduction of biosimilars, competitive market dynamics, and clinical advancements. These findings provide valuable insights for healthcare policymakers, payers, and clinicians to..."

Medicaid • Reimbursement • US reimbursement • Hematological Disorders • Immune Thrombocytopenic Purpura • Thrombocytopenia • Thrombocytopenic Purpura

Industry perspective on regulatory authority (RA) quality reviews of biosimilar applications - an evaluation of RA guidance and expectations for chemical, manufacturing, and controls information through in-depth query analysis. (PubMed, Expert Opin Biol Ther) - "Numbers/types of queries received following regulatory submissions (FDA/EMA, n = 7/n = 5) for seven biosimilars (PF-filgrastim [Nivestym], PF-rituximab [Ruxience®], PF-trastuzumab [Trazimera®], PF-bevacizumab [Zirabev®], PF-pegfilgrastim [Nyvepria®], PF-adalimumab [Abrilada™/Amsparity®], PF-infliximab [Ixifi]) from a single product portfolio were analyzed considering published regulatory authority (RA) guidance and in relation to sections/subsections of Module 3: Quality from the Common Technical Document regulatory dossier and topics based on keyword assignment. Topic assignments included: Control (12-27%/12-28%), Manufacturing (56-72%/34-66%), Stability (1-12%/2-24%), Biosimilarity (5-16%/5-25%), and Container Closure (0-3%/0-9%). The focus of both RAs on topics related to manufacturing and controls is valuable in understanding expectations for scientific and technical content related to gaining biosimilar approval."

Journal

Effect of rituximab on remissions without minimal residual disease and immunogenicity in patients with relapsed/refractory hairy cell leukemia receiving moxetumomab pasudotox. (ASCO 2024) - P1 | " After 13 patients received Moxe-Rituximab (MoxeR) without dose-limiting toxicity (DLT), meeting the phase 1 endpoint, 5 additional patients received Moxe with the biosimilar Ruxience (MoxeR). Despite enrolling slightly fewer patients than planned, MoxeR was safe and more effective than Moxe alone at achieving MRD-free CR, probably due to lower immunogenicity and faster reduction of HCL/HCLv tumor burden. Since non-Hodgkin's lymphoma (NHL) cells from patients are sensitive to Moxe like HCL, MoxeR could be tested after NHL treatment to convert MRD+ to MRD-free CRs. Clinical trial information: NCT03805932."

Clinical • Minimal residual disease • Residual disease • Atypical Hemolytic Uremic Syndrome • Hairy Cell Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Nephrology • Non-Hodgkin’s Lymphoma • Oncology • CD20

DC Veterans Affairs Quality Improvement Project of Highly Efficacious Anti-CD20 Disease-Modifying Treatments (CMSC 2024) - "OBJECTIVES: We compared cost, safety, and efficacy of biosimilar rituximab PVVR to ocrelizumab in a quality improvement (QI) project (institutional review board approved as “not research”) of predominantly African American male veterans receiving care at the Washington DC Veterans Affairs Medical Center. Drug costs are 80% of the overall economic burden of living with MS. Use of biosimilar rituximab PVVR represents an annual savings of $59,986.10. Our results support the use of a biosimilar anti-CD20 agent as a safe and efficacious DMT."

CNS Disorders • Multiple Sclerosis

DanNORMS: Non-inferiority Study of Ocrelizumab and Rituximab in Active Multiple Sclerosis (clinicaltrials.gov) - P3 | N=600 | Active, not recruiting | Sponsor: Rigshospitalet, Denmark | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2028 ➔ May 2028 | Trial primary completion date: Dec 2025 ➔ May 2026

Enrollment closed • Head-to-Head • Trial completion date • Trial primary completion date • CNS Disorders • Multiple Sclerosis • C1Q • C1QA • FCER1G • NEFL

Impact of AT1R Antibody+ on Allograft Outcomes after Desensitization (ATC 2024) - "Pre-transplant DES for G1 included anti-CD20 (Ruxience) up to 1gm (Week 0 & 2) + IVIG 2gm/kg (Week 3 & 6) {RUX protocol} while G2 received RUX protocol or PLEX x5 + RUX protocol ± Tocilizumab. All transplanted patients received induction with alemtuzumab and maintained on tac/mmf/pred.* Briefly, median age was 59.5yrs (IQR: 23-62) vs. 50 yrs (IQR: 27-67); LD transplants was 67% vs 20%; and AT1R levels >40 U/ml was 63% vs. 40% (G1 vs. G2 respectively)... Pre-Tx DES for AT1R+ allows for successful kidney transplantation w/out rejection post-tx. Reduction in AT1R levels was seen with desensitization, but clinical relevance of AT1R ab in mediating rejection is unclear. Further studies will be needed to determine impact of DES on AR episodes, graft function & survival."

Inflammation • Transplantation

Safety of marketed biosimilar monoclonal antibody cancer treatments in the US: a disproportionality analysis using the food and drug administration adverse event reporting system (FAERS) database. (PubMed, Expert Opin Drug Saf) - "Significant AE reporting signals were identified: 1) death for biological rituximab, pruritus for biosimilar rituximab-pvvr, and infusion related reaction for biological rituximab and biosimilar rituximab-pvvr (significantly higher ROR for rituximab-pvvr than biological rituximab, p < .0001); 2) death for biological bevacizumab and biosimilar bevacizumab-bvzr (significantly higher ROR for bevacizumab-bvzr than biological bevacizumab, p < .0001), hypertension, platelet count decreased (PCD), and proteinuria for biological bevacizumab and biosimilar bevacizumab-awwb (significantly higher ROR of PCD for bevacizumab-awwb than originator bevacizumab, p = .001); and 3) rash for biosimilar trastuzumab-anns. Findings call for large, longitudinal studies to examine causality of certain AEs with rituximab-pvvr and bevacizumab biosimilars."

Adverse events • Journal • Cardiovascular • Dermatology • Hypertension • Oncology • Pruritus • Renal Disease

Rapamycin is an Important Component of an Immunosuppression Regimen to Inhibit Capsid-Specific Humoral Immune Responses in High-Dose AAV Gene Therapy in Cynomolgus Macaques (ASGCT 2024) - "The combination immunosuppression regimen of prednisolone/rapamycin/rituximab-pvvr was well tolerated, reduced anti-capsid IgM and IgG, and increased VG levels in the serum following high-dose rAAV gene therapy with AAVhu37. These results suggest that rapamycin is an important component of the IS regimen to reduce anti-capsid humoral immune responses."

Gene therapy • Anemia • Atypical Hemolytic Uremic Syndrome • Complement-mediated Rare Disorders • Duchenne Muscular Dystrophy • Gene Therapies • Genetic Disorders • Hematological Disorders • Muscular Dystrophy • Nephrology • Thrombocytopenia