Rituximab biosimilar RTXM83 versus reference rituximab in combination with CHOP as first-line treatment for diffuse large B-cell lymphoma: a randomized, double-blind study

Candelaria, Myrna; Gonzalez, Derlis; Delamain, Márcia Torresan; Bär, Daniel; Beniwal, Surender; Dasappa, Lokanatha; Flores, David; Querol, J. Marruecos; Guan, Toh See; Lipatov, Oleg; Volodicheva, Elena; Patel, Moosa; Nodehi, Sayyed Reza Safaee; Fogliatto, Laura; Paravisini, Alexandra; Diaz, Luis Perez; study, Rtxm

doi:10.1080/10428194.2019.1633632

Cited by 25 publications

(36 citation statements)

References 24 publications

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“…RTXM83 is approved in Argentina as a rituximab biosimilar. Published data are available for analytical and preclinical testing, as well as from a Phase III clinical trial in DLBCL [79][80][81]. Preclinical comparisons for RTXM83 and reference rituximab confirmed matching primary and higher-order structures, and post-translational modifications.…”

Section: Rituximab Biosimilars In Developmentmentioning

confidence: 91%

“…Overall, preclinical data showed that RTXM83 and reference rituximab are highly similar in terms of structure and function. In a Phase III confirmatory trial in DLBCL, the primary endpoint of noninferiority in ORR between RTXM83 and reference rituximab was met [81]. PK/PD profiles were also shown to be similar between the two treatment arms.…”

Section: Rituximab Biosimilars In Developmentmentioning

confidence: 99%

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Rituximab biosimilars for lymphoma in Europe

Jurczak

Długosz-Danecka

Buske

2019

Expert Opinion on Biological Therapy

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Introduction: The approval of rituximab, a monoclonal antibody targeting CD20, revolutionized the treatment of B-cell non-Hodgkin lymphomas and became an undisputed standard of care. However, as with all biologic medicines, the complex development and manufacturing process for rituximab have meant that the medicine attracts high treatment costs. Approved rituximab biosimilars have been comprehensively demonstrated to match the reference medicine. With the potential to increase access to biologic therapy, they have a key role in helping to improve patient outcomes in lymphoma care. Areas covered: In this review, we discuss the role of rituximab in the treatment of lymphoma. We explore development and regulatory requirements for biosimilar development and the potential impact of these medicines on access and sustainability. Focusing on biosimilars of rituximab, we examine in detail the evidence for biosimilarity for the two rituximab biosimilars that are approved in Europe and provide an overview of rituximab biosimilars currently in development. Expert opinion: We foresee a wider uptake of biosimilar medicines for lymphoma treatment over the next 5 years. The associated cost savings should be invested in broadening patient access to biological therapies, enabling wider use of more expensive treatment strategies and driving innovation in cancer care.

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Section: Rituximab Biosimilars In Developmentmentioning

confidence: 91%

Section: Rituximab Biosimilars In Developmentmentioning

confidence: 99%

Rituximab biosimilars for lymphoma in Europe

Jurczak

Długosz-Danecka

Buske

2019

Expert Opinion on Biological Therapy

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“…mAbxience (RTXM83) chose patients with this indication (DLBCL) as the most sensitive population, that exhibits good clinical responses to RTX in combination with cyclophosphamide, doxorubicin, vincristine and prednisone. Despite the challenging of recruiting, it was the first completed biosimilar comparability study in this patient setting despite the challenging of recruiting [56]. Later, HLX01, the candidate of Henlius was evaluated in the same population [54].…”

Section: Pharmacological Assessment Of Biosimilarity: Pk and Pd Comparative Studiesmentioning

confidence: 99%

“…Most developers such as Amgen, Boehringer Ingelheim, Mylan and Sandoz, performed two-sided equivalence trials to demonstrate similar clinical efficacy and safety to the RMP. In contrast, the RTX candidates RTXM83 (mAbxience) and Zytux TM (AryoGen Pharmed) were evaluated in a noninferiority trial [56,57]. The BEV candidate of Biocad (BCD-021) was also tested in a noninferiority trial [42].…”

Section: Pharmacological Assessment Of Biosimilarity: Pk and Pd Comparative Studiesmentioning

confidence: 99%

Current State and Comparison of the Clinical Development of Bevacizumab, Rituximab and Trastuzumab Biosimilars

Millán¹,

Chaban²,

Campo³

et al. 2021

Future Oncol.

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Monoclonal antibodies are highly complex, large and biologic products with a substantial impact on the clinical management of a variety of diseases including cancer. The expiry of patents for essential monoclonal antibodies in cancer care such as bevacizumab, rituximab and trastuzumab, has prompted the global development of biosimilars to balance the biologics market. However, an understanding of the different approach of biosimilar development compared with its reference medicinal product, especially in the context of clinical trial design and end point selection may help oncologists integrating biosimilars into clinical practice. Herein, we reviewed the clinical development of biosimilars in oncology comparing the available clinical data of proposed biosimilars of bevacizumab, rituximab and trastuzumab.

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“…Other rituximab biosimilars have been developed (eg, MK-8808, BI 695500), but the manufacturers have since terminated development and are no longer listing the rituximab biosimilars as part of their product pipeline. 56-59…”

Section: Rituximab Biosimilar Use In Non-hodgkin Lymphomamentioning

confidence: 99%

A Clinical Review of Biosimilars Approved in Oncology

Ngo

Chen

2020

Ann Pharmacother

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Objective: To summarize and review the clinical data of Food and Drug Administration (FDA)-approved biosimilars for use in treatment of cancer and the current challenges health care institutions face when implementing a newly approved biosimilar. Data Sources: A literature search of the following databases was performed between January 1, 2012, and December 31, 2019: PubMed, Google, and ClinicalTrials.gov. Search terms included the words biosimilar, bevacizumab, rituximab, and/or trastuzumab. Study Selection and Data Extraction: Only primary literature on biosimilars with an ongoing or completed phase 3 trial and/or FDA approval were included in the final analysis. Primary literature consisted of peer-reviewed publications, published abstracts, and any results posted on the ClinicalTrials.gov database. Data Synthesis: Clinical trials of FDA-approved biosimilars for bevacizumab, rituximab, and trastuzumab showed no significant differences with respect to efficacy, safety, and pharmacokinetics when compared with their reference products. Relevance to Patient Care and Clinical Practice: The anticipated growth of biologics in oncology and the recent introduction of biosimilars over the past few years have placed a lot of emphasis on biosimilars as a significant source of cost savings for the health care system. Our article compiles and analyzes existing data on biosimilar efficacy, safety, and financial impact. Conclusions: The major concerns of biosimilars revolve around their long-term efficacy and safety. Even with many questions to be answered, biosimilars have the potential for significant cost savings in the US health care system.

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Rituximab biosimilar RTXM83 versus reference rituximab in combination with CHOP as first-line treatment for diffuse large B-cell lymphoma: a randomized, double-blind study

Abstract: & on behalf of the RTXM83 study (2019) Rituximab biosimilar RTXM83 versus reference rituximab in combination with CHOP as first-line treatment for diffuse large B-cell lymphoma: a randomized, double-blind study,

Cited by 25 publications

References 24 publications

Rituximab biosimilars for lymphoma in Europe

Rituximab biosimilars for lymphoma in Europe

Current State and Comparison of the Clinical Development of Bevacizumab, Rituximab and Trastuzumab Biosimilars

A Clinical Review of Biosimilars Approved in Oncology

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