Ituxredi (rituximab biosimilar) / Dr. Reddy’s, Abbott, EMD Serono, CinnaGen, Fresenius Kabi, R-Pharm - LARVOL DELTA

Comparing immunogenicity and safety following transition from reference rituximab to biosimilar rituximab (DRL_RI) in patients with rheumatoid arthritis: a randomized, double-blind, phase 3 study. (PubMed, Arthritis Res Ther) - P3 | "Immunogenicity was low and comparable in RA patients transitioning to DRL_RI or continuing on RP/RMP. The overall safety profile in patients transitioning to DRL_RI did not appear to differ in frequency, severity, or quality from patients continuing on RP/RMP and was in line with the known safety profile of rituximab."

Clinical • Journal • P3 data • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Efficacy and Safety of Rituximab Biosimilar (DRL_RI) Versus Mabthera in Low Tumor Burden Follicular Lymphoma: The Flinter Study (ASH 2024) - P3 | "Treatment-emergent adverse events were reported in 68.6% of patients; safety, immunogenicity, and mean serum drug concentrations were similar between groups. Peripheral B-cell counts declined below quantifiable limits in most patients, with a median time to B-cell depletion of 6.9 days vs. 7.0 days for DRL_RI vs. MabThera®.Conclusion : The study demonstrated efficacy equivalence of DRL_RI to MabThera®; with comparable safety, immunogenicity, serum drug concentrations, and PD between groups.Clinical Trial Registry Information : This trial was registered at ClinicalTrials.gov identifier : NCT03976102 and EudraCT (2018-004223-36)."

Clinical • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Oncology • CD20

Comparing Immunogenicity and Safety Following Transition from Reference Rituximab to Biosimilar Rituximab (DRL_RI) in Patients with Rheumatoid Arthritis: A Randomized, Double-blind, Phase 3 Study (ACR Convergence 2024) - "Immunogenicity was low and comparable in RA patients transitioning to DRL_RI or continuing RP/RMP. The overall safety profile in patients transitioning to DRL_RI did not differ in frequency, severity from patients continuing RP/RMP and was consistent with the known safety profile of rituximab."

Clinical • P3 data • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Dr. Reddy’s biosimilar gets recommendation from European Medicines Agency (Financialexpress) - "Dr. Reddy’s Laboratories Ltd. on Monday announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the launch of its proposed biosimilar Rituximab candidate DRL_RI (ITUXREDI) in European markets"

CHMP • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

B cells: an update on metabolism, signalling and translational perspectives for rheumatology (BSR 2024) - "Therefore, the audience attending this session will benefit from an update on three key areas of significant interest and new developments in the field of B cell biology and targeted therapies in autoimmunity. Aim: To provide an update on novel insights into B cell metabolism, signalling and translational perspectives of direct relevance to rheumatology Objective1: Understanding of how cell metabolism regulates B cell development and differentiation in autoimmune disease Objective2: Appreciate how B cell receptors and co-receptors fine tune response to activation cues in autoimmune disease and ageing Objective3: Understand how genetic and functional analyses of Fc gamma receptors influence response to rituximab therapy for autoimmunity"

Immunology • Inflammatory Arthritis • Lupus • Rheumatoid Arthritis • Rheumatology • Systemic Lupus Erythematosus • TFAM

FLINTER: Compare Efficacy, Safety, and Immunogenicity of Proposed Rituximab Biosimilar (DRL_RI) With MabThera® in LTB Follicular Lymphoma (clinicaltrials.gov) - P3 | N=317 | Completed | Sponsor: Dr. Reddy's Laboratories Limited | Active, not recruiting ➔ Completed

Trial completion • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Oncology • CD20

RI-01-007: A Phase III Transition Study of DRL Rituximab to Reference Medicinal Products (clinicaltrials.gov) - P3 | N=140 | Completed | Sponsor: Dr. Reddy's Laboratories Limited | Active, not recruiting ➔ Completed

Trial completion • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Real-world outcomes of diffuse large B-cell lymphoma in the biosimilar era. (PubMed, Front Oncol) - "Redituxâ„¢ and Ristova were comparable in real-world setting. ISRCTN registry, identifier (ISRCTN13301166)."

Journal • Real-world • Real-world evidence • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • BCL2

Dr. Reddy’s Proposed Rituximab Biosimilar Application Accepted for Review by USFDA, EMA and MHRA (Businesswire) - "Dr. Reddy’s Laboratories Ltd...announced that its Biologics License Application (BLA) for its proposed biosimilar rituximab candidate DRL_RI has been accepted for a substantive review by the U.S. Food and Drug Administration (USFDA). This closely follows acceptance of its rituximab biosimilar dossier for review by two other regulatory agencies – the European Medicines Agency (EMA) and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA)."

European regulatory • sBLA • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Immunology • Leukemia • Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Rheumatoid Arthritis

Dr. Reddy’s successfully completes full set of clinical studies of its rituximab biosimilar for filing in the U.S., Europe (Businesswire) - "Dr. Reddy’s Laboratories Ltd....announced that it has successfully completed the full set of clinical studies of its proposed rituximab biosimilar candidate, DRL_RI, for filing in highly regulated markets such as the United States, Europe and other regions. DRL_RI is being developed as a biosimilar of rituximab, a cluster of differentiation 20 (CD20) directed cytolytic antibody for approval in the United States, European Union and other regions for various indications including treatment of adult patients with rheumatoid arthritis, non-Hodgkin's lymphoma, chronic lymphocytic leukaemia, pemphigus vulgaris, granulomatosis with polyangiitis and microscopic polyangiitis....With the successful completion of these clinical studies, Dr. Reddy’s is now preparing to file Biologics License Application (BLA) / Marketing Authorisation Application (MAA) dossiers with various regulatory authorities globally."

BLA • European regulatory • Non-US regulatory • Trial completion • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Rituximab Plus CHOP Chemotherapy for Diffuse Large B-cell Lymphoma (clinicaltrials.gov) - P2 | N=39 | Completed | Sponsor: UNC Lineberger Comprehensive Cancer Center | Active, not recruiting ➔ Completed | Trial completion date: Jul 2024 ➔ Jul 2022

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

Rituximab PK and PKPD evaluation based on a study in diffuse large B-cell lymphoma: influence of tumor size on PK and assessment of PK similarity. (PubMed, CPT Pharmacometrics Syst Pharmacol) - "DRL-rituximab (DRL_RI, Dr. The different rituximab exposure initially detected between drug products (6.75%) was shown using PK/PKPD analysis to be due to a tumor size imbalance between treatment groups. PK/PKPD analyses may contribute to PK similarity assessments."

Journal • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Biosimilar Rituximab (Redditux) Added to CHOP Chemotherapy for De-novo Diffuse Large B-cell Lymphoma Patients: Real-life Single Center Experience. (PubMed, Turk J Haematol) - "Additionally, CNS relapse ratio was a major concern for our RED cohort. Large prospective controlled studies and real-life data with longer follow-up are needed to document the non-inferiority of RED compared to MAB."

Journal • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

FLINTER: Compare Efficacy, Safety, and Immunogenicity of Proposed Rituximab Biosimilar (DRL_RI) With MabThera® in LTB Follicular Lymphoma (clinicaltrials.gov) - P3 | N=317 | Active, not recruiting | Sponsor: Dr. Reddy's Laboratories Limited | Recruiting ➔ Active, not recruiting | Trial completion date: Sep 2020 ➔ Mar 2023 | Trial primary completion date: Sep 2020 ➔ Sep 2022

Enrollment closed • Trial completion date • Trial primary completion date • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Oncology • CD20

RI-01-007: A Phase III Transition Study of DRL Rituximab to Reference Medicinal Products (clinicaltrials.gov) - P3 | N=140 | Active, not recruiting | Sponsor: Dr. Reddy's Laboratories Limited | Recruiting ➔ Active, not recruiting | Trial completion date: May 2021 ➔ Apr 2022 | Trial primary completion date: May 2021 ➔ Jan 2022

Enrollment closed • Trial completion date • Trial primary completion date • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

R-CHOP Chemotherapy Including Biosimilar Rituximab (Redditux ®) for De-Novo Diffuse Large B-Cell Lymphoma Patients: Real-Life Single Center Experience (ASH 2021) - "The CNS relapse rate was relatively high (9.8%) in our cohort. Prospective randomized clinical trials are needed to determine the efficacy and safety profile of Redditux."

Clinical • Anemia • Diffuse Large B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Herpes Zoster • Infectious Disease • Leukopenia • Lymphoma • Multiple Myeloma • Nephrology • Neutropenia • Non-Hodgkin’s Lymphoma • Novel Coronavirus Disease • Oncology • Pneumonia • Respiratory Diseases • Thrombocytopenia • Varicella Zoster • CSF3

Rituximab Plus CHOP Chemotherapy for Diffuse Large B-cell Lymphoma (clinicaltrials.gov) - P2; N=39; Active, not recruiting; Sponsor: UNC Lineberger Comprehensive Cancer Center; Trial completion date: Dec 2022 ➔ Jul 2024; Trial primary completion date: Mar 2021 ➔ Jul 2021

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

Safety and Efficacy of Intrathecal Rituximab in Patients With Multiple Sclerosis (clinicaltrials.gov) - P1; N=40; Recruiting; Sponsor: St. Petersburg State Pavlov Medical University

Clinical • New P1 trial • CNS Disorders • Gene Therapies • Hematological Disorders • Immunology • Multiple Sclerosis • CD27 • CD5 • CD8 • MRI • PTPRC

Simultaneous Monitoring of Monoclonal Antibody Variants by Strong Cation-Exchange Chromatography Hyphenated to Mass Spectrometry to Assess Quality Attributes of Rituximab-Based Biotherapeutics. (PubMed, Int J Mol Sci) - "Moreover, the two drug products showed differences in terms of basic variants such as C-terminal lysine and N-terminal truncation, present in Reditux™ but not in MabThera. This study demonstrates the capability of this fast SCX-HPLC-MS approach to compare different drug products and simultaneously assess some of their quality attributes."

Journal

Rituximab Plus CHOP Chemotherapy for Diffuse Large B-cell Lymphoma (clinicaltrials.gov) - P2; N=39; Active, not recruiting; Sponsor: UNC Lineberger Comprehensive Cancer Center; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Human Immunodeficiency Virus • Infectious Disease • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20

Sedimentation Velocity Analytical Ultracentrifugation Analysis of Marketed Rituximab Drug Product Size Distribution. (PubMed, Pharm Res) - "SV-AUC provides an orthogonal characterization tool for protein size distribution, composition and assay, which could be informative for biosimilar drug developers who mostly only have access to formulated mAb. However, AUC needs thorough validation on its accuracy, precision and sensitivity."

Journal

Randomized, Double-Blind, Pharmacokinetic Equivalence Trial Comparing DRL-Rituximab With MabThera in Patients With Diffuse Large B-Cell Lymphoma. (PubMed, J Glob Oncol) - "DRL_RI and RMP had equivalent PKs, with comparable efficacy, PDs, safety, and immunogenicity."

Clinical • Journal • PK/PD data • Diffuse Large B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

[VIRTUAL] R-CHOP CHEMOTHERAPY INCLUDING BIOSIMILAR RITUXIMAB (REDDITUX ®) FOR DE-NOVO DIFFUSE LARGE B-CELL LYMPHOMA PATIENTS: REAL LIFE SINGLE CENTER EXPERIENCE (EHA 2020) - "Infusion reactions were observed in 20% of patients. Prospective randomized clinical trials are needed to determine the efficacy and safety profile of Redditux®."

Clinical • CNS Disorders • Diffuse Large B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukopenia • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Pneumonia • Respiratory Diseases • Thrombocytopenia • CSF3

Rituximab biosimilar to launch in Turkish Market (Center for Biosimilars) - "The company has now announced that the biosimilar, indicated for the treatment of non-Hodgkin lymphoma and chronic lymphocytic lymphoma, will be launched shortly."

Launch non-US • Biosimilar • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology

Reditux: Anticipated launch in Europe between FY2018 - 2021 (Dr. Reddy’s) - Investor Presentation

Anticipated biosimilar launch • Biosimilar