Ruxience (rituximab-pvvr) / Pfizer - LARVOL DELTA

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

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

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

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

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

Evaluating the Usage of Ruxience (rituximab-pvvr) in a Community Teaching Hospital (ASHP 2023) - No abstract available

Clinical

Treatment Patterns, Safety, and Effectiveness of Rituximab Originator versus Rituximab-pvvr within the Veterans Health Administration (ASHP 2023) - No abstract available

Clinical

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

Rituximab-pvvr and Abatacept vs Rituximab-pvvr Alone in New Onset Type 1 Diabetes (clinicaltrials.gov) - P2 | N=74 | Recruiting | Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Suspended ➔ Recruiting | N=36 ➔ 74 | Trial completion date: Apr 2027 ➔ Oct 2029 | Trial primary completion date: Apr 2026 ➔ Oct 2027

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

DanNORMS: Non-inferiority Study of Ocrelizumab and Rituximab in Active Multiple Sclerosis (clinicaltrials.gov) - P3 | N=594 | Recruiting | Sponsor: Rigshospitalet, Denmark | Trial completion date: Apr 2028 ➔ Dec 2028 | Trial primary completion date: Apr 2025 ➔ Dec 2025

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

Aptevo Therapeutics Reports 2Q23 Financial Results and Provides a Business Update (Issuer Direct) - "Royalty revenue for the period covered by this report reflects revenue recorded only in the first quarter of 2022 due to our Amendment to Royalty Purchase Agreement with HCR. As a result of the amendment, we ceased reporting as royalty revenue, royalties paid by Pfizer to HCR related to Pfizer's sales of RUXIENCE®....Research and development expenses increased by $1.6 million, from $3.9 million for three months ended June 30, 2022 to $5.5 million for the three months ended June 30, 2023. The increase was primarily due to higher spending on the ALG.APV-527 Phase 1 clinical trial and APVO436 Phase 1b clinical trial. "

Commercial • Acute Myelogenous Leukemia • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Marginal Zone Lymphoma • Myelodysplastic Syndrome • Non-Hodgkin’s Lymphoma • Oncology

19-C-0042: Moxetumomab Pasudotox-tdfk (Lumoxiti(TM)) and Either Rituximab (Rituxan(R)) or Ruxience for Relapsed Hairy Cell Leukemia (clinicaltrials.gov) - P1 | N=15 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial primary completion date: Jun 2024 ➔ Jul 2023

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

Moxetumomab-Rituximab to Eliminate Minimal Residual Disease in Hairy Cell Leukemia (PEGS 2023) - "Complete remissions in hairy cell leukemia (HCL) with anti-CD22 recombinant immunotoxin Moxetumomab Pasudotox (Moxe) are more durable if minimal residual disease (MRD) negative, but anti-drug antibodies (ADA) can limit the effectiveness of the consolidation cycles needed to eliminate MRD. To prevent ADA, Rituximab or Ruxience was added to Moxe (MoxeR) and 9 (64%) of 14 evaluable patients so far achieved MRD-free CR. ADA was less frequent than Moxe alone historically."

Minimal residual disease • Residual disease • Hairy Cell Leukemia • Hematological Malignancies • Leukemia • Oncology

Immunosuppression to Inhibit Capsid-Specific Humoral Immune Responses in High-Dose AAV Gene Therapy in Cynomolgus Macaques (ASGCT 2023) - "Four days after vector administration, Group 5 also exhibited significantly higher vector genome DNA levels in the serum, possibly due to the lower anti-capsid antibody levels. A transient increase in complement (C5b9 and C3a) proteins and a transient decrease in platelet numbers were observed in only a subset of animals from all dosed groups within the first week.The combination of prednisolone, rapamycin and rituximab-pvvr was well tolerated and reduced anti-capsid IgM and IgG following high-dose rAAV gene therapy."

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

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

Journal • CNS Disorders • Multiple Sclerosis

[VIRTUAL] Cost-Effectiveness of Obinutuzumab Plus Chemotherapy Versus Rituximab Biosimilars Plus Chemotherapy for Patients with Previously Untreated Follicular Lymphoma (SOHO 2020) - "The FDA has approved two R biosimilars for use in combination with chemotherapy in this setting, rituximab-abbs (Ra) and rituximab-pvvr (Rp); however, it has not yet been determined if they are cost-effective vs G+chemo. As a result of delayed progression treatments and increasing QALYs, these data indicate that G+chemo is likely cost-effective in the US as first-line therapy for follicular lymphoma, despite the lower cost of R-biosimilars compared with R."

Clinical • HEOR • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Oncology

19-C-0042: Moxetumomab Pasudotox-tdfk (Lumoxiti(TM)) and Either Rituximab (Rituxan(R)) or Ruxience for Relapsed Hairy Cell Leukemia (clinicaltrials.gov) - P1 | N=15 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Recruiting ➔ Active, not recruiting | N=30 ➔ 15

Enrollment change • Enrollment closed • Hairy Cell Leukemia • Hematological Malignancies • Leukemia • Oncology

"Lenolidimide (and Ruxience) is keeping my mcl in check." (@griffineliz)

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