Rixathon (rituximab biosimilar) / Kyowa Kirin, Sandoz - LARVOL DELTA

Real-world experience of effectiveness of non-medical switch from originator to biosimilar rituximab and between biosimilars in connective tissue diseases and vasculitis (EULAR 2025) - "Furthermore, between 2021-2023, patients on Truxima® were switched to Rixathon® and then reverted to Truxima® in 2024 due to contractual agreement...Kaplan-Meier analysis showed no difference in 5-year RTX retention survival between Group 1 and Group 2; HR 0.71 (95% CI 0.30-1.71), p=0.448, adjusted for disease duration, number of RTX cycles and oral prednisolone dose (Figure 1)... Our findings support the non-medical switch either from RTX-O to RTX-B or between biosimilars in CTD-VAS with no difference in clinical response and the depth of B-cell depletion before and after switch. 5-year rituximab retention rate was very good regardless of non-medical switch and appeared higher than in RA. Given its low cost and durability, future studies should assess the cost-effectiveness of first-line use of rituximab biosimilars in patients with CTD-VAS."

Clinical • Real-world • Real-world evidence • Infectious Disease • Inflammatory Arthritis • Myositis • Novel Coronavirus Disease • Pneumonia • Pulmonary Disease • Respiratory Diseases • Rheumatoid Arthritis • Rheumatology • Scleroderma • Septic Shock • Systemic Sclerosis • Vasculitis • CD20

Switching from rituximab originator to GP2013 or CT-P10 biosimilars in autoimmune rheumatic diseases: drug retention rate and safety data from a multicentric retrospective cohort. (PubMed, Ther Adv Musculoskelet Dis) - "NMS to RTX-B is associated with a high chance of retaining the drug for up to 36 months, irrespective of the diagnosis. GP2013 showed a higher retention rate than CT-P10."

Journal • Retrospective data • Immunology • Rheumatology

Comparison of the Safety and Effectiveness of Originator Rituximab (Mabthera®) versus Biosimilar (Riximyo®) in Rheumatoid Arthritis: A Retrospective Unicentric Analysis (ACR Convergence 2024) - "Background/Purpose: Immunobiological drugs emerged as a revolutionary option for treating inflammatory chronic rheumatic diseases, particularly rheumatoid arthritis (RA). In this real-life retrospective analysis, we found a similar pattern of articular response and infusional safety among patients who received originator MBT and biosimilar RIX, confirming data from pharmacokinetic and phase III clinical studies used to RIX approval. However, historical discrepancies regarding the availability and indication of the drug precludes a definitive conclusion."

Retrospective data • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

In-Use Physicochemical Stability of Sandoz Rituximab Biosimilar in 0.9% Sodium Chloride Solution After Prolonged Storage at Room Temperature Conditions. (PubMed, Drugs R D) - "These data show that the physicochemical and biological quality of SDZ-RTX diluted in 0.9% NaCl infusion bags is assured, even after prolonged worst-case (out-of-fridge and in-use) storage at elevated temperatures up to 30 °C, if the medication is prepared under aseptic conditions according to the Summary of Product Characteristics."

Journal

Safety of Rituximab biosimilar (Riximyo®) following a single switch from the reference product in patients with Non-Hodgkin's lymphoma: a retrospective study. (PubMed, Ann Hematol) - "There was no statistical significant differences for any safety outcomes examined. Switching therapy for patients receiving rituximab does not lead to poorer safety outcomes."

Journal • Retrospective data • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

INFUSION-RELATED REACTIONS IN PATIENTS WITH CHRONIC LYMPHOPROLIFERATIVE DISORDERS TREATED WITH TWO RITUXIMAB BIOSIMILARS: SINGLE CENTER EXPERIENCE (EHA 2024) - "Aims: To assess frequency and severity of IRRs to rituximab biosimilars Rixathon® and Blitzima® administered topatients with chronic lymphoproliferative disorders (cLPDs) treated at Clinic for Hematology, University ClinicalCenter of Serbia, Belgrade, Serbia from 2020 to 2022...All pts received premedication consisted ofmethylprednisolone 1mg/kg, paracetamol 1g, and loratadine 10mg... Incidence of IRR in our cohort was comparable with literature data. DLBCL patients suffered from IRRs lessfrequently than pts with other cLPDs. Also, pts receiving rituximab in 2nd+ treatment line more frequentlyexhibited IRR."

Clinical • Cardiovascular • Chronic Lymphocytic Leukemia • Coronary Artery Disease • Diabetes • Diffuse Large B Cell Lymphoma • Hematological Disorders • Metabolic Disorders • Oncology • Pulmonary Arterial Hypertension

Rituximab Objective Outcome measures Trial in SLE (ROOTS): Outcomes of randomised and rescue rituximab therapy in a double-blind randomised placebo-controlled trial (LUPUS 2024) - "Patients were randomized to 1000mg Rixathon or placebo, on days 1 and 15, each preceded by 100mg methylprednisolone. Initial worsening before benefit with rituximab may be explained by increased antigenic load and removal of B cell regulatory functions before beneficial effects on plasma cells and B cell antigen presentation are manifest. Detecting such nuances may reflect the greater sensitivity of this trial design."

Clinical • Immunology • Inflammatory Arthritis • Lupus

Long-Term Real-World Post-approval Safety Data of Multiple Biosimilars from One Marketing-Authorization Holder After More than 18 Years Since Their First Biosimilar Launch. (PubMed, Drug Saf) - "This is one of the largest reviews of post-approval biosimilar pharmacovigilance data to date by one MAH. The real-world experience of all eight marketed Sandoz biosimilars for up to 18 years demonstrates that Sandoz biosimilars can be used as safely as their respective reference biologics. Therefore, patients and healthcare providers can be confident in the clinical benefit and safety of Sandoz biosimilars. It is reasonable to believe that similar conclusions about safety may be reached for other biosimilars developed and approved to the high standards as are already in place by major health authorities such as the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). The long-term safety of biosimilars demonstrated here provides strong support for the concept of biosimilarity."

Biosimilar launch • Journal • Real-world • Real-world evidence

Rituximab Objective Outcome Measures Trial in SLE (ROOTS): Randomised and Rescue Therapy Outcomes from a Randomised Controlled Trial (ACR Convergence 2023) - "Patients were randomized to 1000mg rituximab (Rixathon, RTX) or placebo, on days 1 and 15. Clinical trials focused on a single feature of SLE (arthritis) are feasible and offer a homogenous trial population, control of standard of care and opportunities for objective imaging. The LAMDA is responsive and associates with validated outcome measures. ROOTS was not powered to measure efficacy but these data suggest potential worsening before benefit from rituximab."

Clinical • Immunology • Inflammation • Inflammatory Arthritis • Lupus • Musculoskeletal Diseases • Pain • Rheumatology

The comparison of safety and cost between reference drug of rituximab and its biosimilar Riximyo in lymphoproliferative disorders and other hematological diseases. Single center experience. (PubMed, Leuk Lymphoma) - "During the study period, after biosimilar introduction, the cost of rituximab decreased by 41%. Rixmyo while maintaining similar safety profile is much more cost-effective."

Journal • Hematological Disorders • Oncology

REFLECT: prospective multicenter non-interventional study evaluating the effectiveness and safety of Sandoz rituximab (SDZ-RTX; Rixathon) in combination with CHOP for the treatment of patients with previously untreated CD20-positive diffuse large B-cell lymphoma. (PubMed, Ther Adv Hematol) - "Real-world, multicenter, open-label, single-arm, non-interventional, post-approval study of SDZ-RTX in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in patients with treatment-naïve CD20‑positive DLBCL. This real-world, 2-year study reconfirms that first-line treatment of CD20-positive DLBCL with R-CHOP using SDZ-RTX is effective and well tolerated. N/A."

Combination therapy • Journal • Observational data • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20

Cost-efficiency analysis and expanded treatment access modeling of conversion to rituximab biosimilars from reference rituximab in Jordan. (PubMed, J Med Econ) - "A 1-year cost-efficiency and expanded access model of conversion from reference rituximab (Mabthera) to the approved biosimilars (Truxima, Rixathon, and Tromax) to assess five metrics: total annual cost to treat a hypothetical patient; head-to-head cost comparison; changes in patients' access to rituximab; number-needed-to-convert (NNC) to provide an additional 10 patients access to a rituximab treatment; and relative amount of Jordanian Dinar (JOD) spent on rituximab options. Rituximab biosimilars were associated with cost savings in all approved indications in Jordan compared to reference rituximab. Rixathon was associated with the lowest annual cost, the highest percentage of expanded patient access for all six indications, and the lowest NNC providing 10 additional patients with access."

Journal

Rituximab Objective Outcome measures Trial in SLE (ROOTS): A double-blind randomised placebo-controlled feasibility trial (EULAR 2023) - "Patients were randomized to 1000mg rituximab (Rixathon, RTX) or placebo, on days 1 and 15. design dedicated to MSK SLE was feasible. The new outcome measures of LAMDA and MSK US were validated against BILAG-MSK; these outcomes should be included in a definitive trial. While not powered to measure efficacy, exploratory analysis suggests unexpectedly greater improvement in patients who received methylprednisolone with placebo compared to methylprednisolone with rituximab at early time points after infusion, later converging by week 16."

Clinical • Late-breaking abstract • Inflammatory Arthritis • Lupus • Musculoskeletal Diseases • Pain

EFFECTIVENESS AND SAFETY OF NON-MEDICAL SWITCH FROM RITUXIMAB ORIGINATOR TO AND AMONG BIOSIMILARS IN SMALL VESSEL VASCULITIDES PATIENTS: REAL WORLD DATA FROM A RETROSPECTIVE MONOCENTRIC STUDY (EULAR 2023) - "All patients were followed-up for at least 12 months and received at least two cycles of therapy with RTX-Or, CT-P10 or GP2013...All patients achieved a statistically significant reduction of mean corticosteroid dose used from 20.4±12.8 mg/day of prednisone equivalents at baseline to 5.0±2.8 mg/day at 12 months (p=0.00016), and of mean BVASv3 from 20.0±4.5 at baseline to 4.7±2.3 after 12 months (p<0.00001)...The effectiveness and safety of NMS for RTX in SVV is confirmed, and our results grant first time evidence for safety and maintained effectiveness of treatment in such patients also after NMS between biosimilars. This practice allows economic sustainability for healthcare systems and represents a hot topic in clinical practice."

Real-world • Real-world evidence • Retrospective data • Dermatology • Immunology • Rare Diseases • Rheumatology • Urticaria • Vasculitis • CRP

REAL-WORLD EXPERIENCE OF BIOSIMILAR RITUXIMAB GP2013 IN RHEUMATOID ARTHRITIS PATIENTS NAÏVE TO OR SWITCHED FROM REFERENCE RITUXIMAB (EULAR 2023) - "Results 110 RA patients (71.8% women) treated with bs-RTX were identified (88 mandatory switched from bo-RTX, 22 RTX-naïve), baseline median (IQR) age was 68.0 (59.0-76.0) years, disease duration 13.0 (7.4-18.7) years, 93.6% were RF and 96.3% ACPA positive, 30.0% currently used csDMARDs (26.4% methotrexate). Response in RTX-naïve patients was satisfactory and effect remains stable after 2-year follow-up. Drug survival was similar to published data for originator RTX."

Clinical • Real-world • Real-world evidence • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Efficacy and safety of two rituximab biosimilars for treating immune thrombocytopenia: a reference-product matched study. (PubMed, Platelets) - "We included 107 patients; 55 receiving Rixathon™ and 52 Truxima™. Safety was analogous to that observed with the reference product. Rituximab biosimilars seemed safe and effective for ITP treatment."

Journal • Hematological Disorders • Thrombocytopenia • Thrombocytopenic Purpura

Real-world experience of rituximab biosimilar GP2013 in rheumatoid arthritis patients naïve to or switched from reference rituximab. (PubMed, Rheumatol Int) - "Two most frequently reported reasons for drug discontinuation were remission (38.6%) and doctor's decision (27.1%). RA patients treated with bs-RTX had satisfactory treatment response and drug retention rates which supports equivalence of bs-RTX GP2013 to bo-RTX, both in patients naïve to and mandatory switched from bo-RTX."

Journal • Real-world • Real-world evidence • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Equivalent efficacy of a biosimilar rituximab and reference rituximab in previously untreated advanced follicular lymphoma: Extended results of ASSIST-FL, a confirmatory phase III study (ESMO 2017) - P3; "The study demonstrated equivalence in ORR between the biosimilar GP2013 and reference rituximab in patients with previously untreated, advanced FL. Similarity in ORR was observed across subgroups and safety profiles were also comparable. Based on the totality of evidence, GP2013 was approved by the EMA and represents an important option for patients that need rituximab and to help sustain the cost of cancer care."

Adverse events • Clinical • P3 data • Indolent Lymphoma

Interpreting progression-free survival and overall survival data in biosimilar clinical studies: considerations based on a recent rituximab biosimilar study (ESMO 2017) - P3; "A confirmatory phase III study compared the efficacy of the EMA approved biosimilar rituximab, GP2013 (n = 314) with reference rituximab (R) (n = 315) in patients with previously untreated, advanced follicular lymphoma. Small sample size, low event rate, data immaturity and/or other aspects of study design can subject survival analyses to chance findings and decrease sensitivity for biosimilarity assessments. In this study, HRs for PFS and OS had opposite directions and CR rates between treatments were similar across time, emphasizing these challenges. The PFS and OS results should be interpreted with caution as they may not reflect a difference, or lack thereof, between treatments."

Clinical • Indolent Lymphoma

Retrospective, Observational Qualitative MR Outcomes in Riximyo-Treated Multiple Sclerosis Patients (ACTRIMS Forum 2023) - "Background: Rituximab was evaluated in relapsing MS in a randomized clinical trial and extensively in observational studies. If confirmed in larger studies, Riximyo (a SEB ritixumab) could be a reasonable alternative agent to use in RRMS, in resource-limited settings."

Retrospective data • CNS Disorders • Infectious Disease • Multiple Sclerosis • Oncology • CD20

The effects of switching anti-CD20 antibodies on treatment response and outcome for patients with B-Non-Hodgkin lymphomas: A single-center retrospective data analysis (DKK 2022) - "Anti-CD20 treatment consisted of 48.2% Mabthera, 34.8% Rixathon, 9.2% Mabthera s.c. 7.8% Obinutuzumab. A switch of Mabthera to the biosimilar Rixathon leads to comparable outcomes and can be done safely in clinical routine."

Retrospective data • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Effectiveness and Safety of Sandoz Biosimilar Rituximab (Rixathon [c]) in Patients with DLBCL: 24-Month Evidence from the REFLECT Study (DKK 2022) - "This study reconfirms that 1st line treatment of CD20+ DLBCL with R-CHOP using SDZ-RTX (Rixathon [c]) is effective over a 24-months observation period with no unexpected safety signals."

Clinical • Anemia • Diffuse Large B Cell Lymphoma • Fatigue • Hematological Disorders • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Pain • CD20

Safety and tolerability of a 90-minute rapid infusion of Sandoz biosimilar rituximab in B-cell lymphoproliferative disorders in a real-world setting. (PubMed, Clin Transl Sci) - "Most rapid infusions of SDZ-RTX were in combination with CHOP/CHOP-like therapy (48.4%), followed by SDZ-RTX alone (15.1%), in combination with bendamustine (14.5%), or with other regimens (22%). The incidence of any grade IRR during the first rapid infusion was 1% (five grade 1 IRRs and one grade 2 IRR). In conclusion, rapid 90-minute IV administration of SDZ-RTX for the second and subsequent infusions during the course of therapy is well tolerated in patients with CD20+ lymphoma or CLL."

Journal • Real-world evidence • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Oncology • CD20

The Efficacy and Safety of gp2013-rituximab: A Rituximab Biosimilar in a Tertiary Care Hospital in Lebanon (ASHP 2022) - No abstract available

Clinical

The prevalence of cancer in patients with multiple sclerosis (MS) who received rituximab: a systematic review and meta-analysis. (PubMed, Neurologia (Engl Ed)) - "The results of this systematic review and meta-analysis show that the pooled prevalence of cancer in MS patients who received rituximab is 1 in 100,000 cases."

Journal • Retrospective data • Review • CNS Disorders • Multiple Sclerosis • Oncology