Comparison of pharmacokinetics and pharmacodynamics of BCD-020 with innovator rituximab in patients with indolent non-Hodgkin lymphoma.

Poddubnaya, I V; Babicheva, L G; Kaplanov, Kamil; Zaritskey, Andrey; Volodicheva, Elena; Alexeev, Sergey; Loginov, Alexander; Орлова, Р. В.; Дворниченко, В. В.; Gladkov, Oleg; Kosinova, Marina; Serduk, Olga; Milovanov, Vladimir; Myasnikov, Alexander; Suresh, A.; Jain, Minish; Patil, Shekhar; Rajappa, Senthil; Ivanov, Roman; Chernyaeva, E.

doi:10.1200/jco.2014.32.15_suppl.e19545

Cited by 5 publications

(3 citation statements)

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“…The study was considered to be of excellent quality [47–49]. ORR on day 50 ± 5 (primary endpoint) in both arms was reported as equivalent ( p = 0.8250).…”

Section: Resultsmentioning

confidence: 99%

Biosimilars for the Treatment of Cancer: A Systematic Review of Published Evidence

Jacobs

Ewesuedo

Lula³

et al. 2017

BioDrugs

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BackgroundBiologic treatments for cancer continue to place a significant economic burden on healthcare stakeholders. Biosimilar therapies may help reduce this burden through cost savings, thereby increasing patient access.ObjectivesThe purpose of this study was to collate all published data to assess the weight of available evidence (quantity and quality) for proposed monoclonal antibody biosimilars and intended copies, for the treatment of cancer.MethodsMEDLINE®, Embase®, and ISI Web of Science® databases were searched to September 2015. Conference proceedings (17) were searched (2012 to July 2015). Searches of the United States National Library of Medicine ClinicalTrials.gov registry were also conducted. Risk of bias assessments were undertaken to assess data strength and validity.ResultsProposed biosimilars were identified in 23 studies (36 publications) in oncology and ten studies in 14 publications in oncology and chronic inflammatory diseases for bevacizumab, rituximab, and trastuzumab originators. Based on our review of the included published studies, and as inferred from the conclusions of study authors, the identified proposed biosimilars exhibit close similarity to their originators. Published data were also retrieved on intended copies of rituximab. It remains unclear what role these agents may have, as publications on rigorous clinical studies are lacking for these molecules.ConclusionWhile biosimilar products have the potential to improve patient access to important biologic therapies, robust evidence of outcomes for monoclonal antibody biosimilars in treating cancer patients, including data from comparative efficacy and safety trials, is not yet available in the published literature. Significant data gaps exist, particularly for intended copies, which reinforces the need to maintain a clear differentiation between these molecules and true biosimilars. As more biosimilars become available for use, it will be important for stakeholders to understand fully the robustness of overall evidence used to demonstrate biosimilarity and gain regulatory approval.Electronic supplementary materialThe online version of this article (doi:10.1007/s40259-016-0207-0) contains supplementary material, which is available to authorized users.

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“…The study was considered to be of excellent quality [47–49]. ORR on day 50 ± 5 (primary endpoint) in both arms was reported as equivalent ( p = 0.8250).…”

Section: Resultsmentioning

confidence: 99%

Biosimilars for the Treatment of Cancer: A Systematic Review of Published Evidence

Jacobs

Ewesuedo

Lula³

et al. 2017

BioDrugs

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“…Phase III: BCD-020 showed equivalent PK and similar PD and safety to rituximab in patients with indolent NHL [41] Phase III: BCD-020 showed similar efficacy (ORR) and safety to rituximab in patients with indolent B-cell non-Hodgkin's lymphoma [42] PF-05280586…”

Section: Indolent Nhlmentioning

confidence: 99%

A clinician’s guide to biosimilars in oncology

Rugo

Linton

Cervi

et al. 2016

Cancer Treatment Reviews

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Biological agents or "biologics" are widely used in oncology practice for cancer treatment and for the supportive management of treatment-related side effects. Unlike small-molecule generic drugs, exact copies of biologics are impossible to produce because these are large and highly complex molecules produced in living cells. The term "biosimilar" refers to a biological product that is highly similar to a licensed biological product (reference or originator product) with no clinically meaningful differences in terms of safety, purity, or potency. Biosimilars have the potential to provide savings to healthcare systems and to make important biological therapies widely accessible to a global population. As biosimilars for rituximab, trastuzumab, and bevacizumab are expected to reach the market in the near future, clinicians will soon be faced with decisions to consider biosimilars as alternatives to existing reference products. The aim of this article is to inform oncology practitioners about the biosimilar development and evaluation process, and to offer guidance on how to evaluate biosimilar data in order to make informed decisions when integrating these drugs into oncology practice. We will also review several biosimilars that are currently in development for cancer treatment.

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“…В этом контролируемом международном многоцентровом исследовании проводилось сравнение фармакокинетики, фармакодинамики, эффективности и безопасности в параллельных группах пациентов с CD20-позитивными иНХЛ, получающих лечение биоаналогом ритуксимаба или препаратом Мабтера ® в виде монотерапии. Полученные в ходе этого исследования результаты продемонстрировали сравнимую клиническую эффективность в двух параллельных группах, что было подтверждено как прямым сравнением, реализованным в рамках исследования, так и ретроспективным анализом предшествующих клинических исследований оригинального препарата ритуксимаба [3].…”

Section: Introductionunclassified

First-line therapy of indolent non-Hodgkin’s lymphoma in routine clinical practice

et al. 2020

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The aim is to evaluate the efficacy of the first-line rituximab-containing therapy of B-cell lymphoproliferative diseases in Russian clinical practice between 2014 and 2017. Materials and methods. In the post-authorisation multicenter study EQUILIBRIUM were included 1 thousand patients aged from 21 to 91 with B-cell non-Hodgkins lymphoma or chronic lymphatic leukemia who had received at least 4 cycles of rituximab-containing therapy using the drug Acellbia. This article was devoted to the group of indolent non-Hodgkins lymphomas and included 253 patients: follicular lymphoma 51% of cases, marginal zone lymphoma 44% of patients, extremely rare were registered lymphoplasmacytic lymphoma and Waldenstrom macroglobulinemia in 3% and in 2% of cases, respectively. The median age in patients with indolent non-Hodgkins lymphomas was 62 years (2191 years). The vast majority of patients were diagnosed with stage IIIIV 190 (75%) of patients. More than 1/2 (53.4%) of patients in routine practice received R-CHOP therapy as a first-line. BR regimen was applied in 15.4% of cases, 14.2% of patients were treated with R-CVP/R-COP. We indicated rare use of rituximab as monotherapy in induction mode only 4.4% of patients. And 2.4% of patients were treated with fludarabine-containing therapy. Results. The final assessment of the effect was carried out after 68 cycles of treatment and as a result the overall effect was more than 90%: the frequency of complete remission was 61%, partial responses 32.9%. The progression admitted only in 17 (6.7%) patients among 253 observed. With a median of 15 months, the median of overall survival and event-free survival was not achieved. Conclusion. The use of the available and appropriate treatment according to the domestic clinical guidelines with the inclusion of the Russian biosimilar anti-CD20 monoclonal antibody Acellbia, demonstrates high direct efficacy and satisfactory long-term treatment results comparable to the retrospective analysis of the previous clinical studies of the original drug rituximab.

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Comparison of pharmacokinetics and pharmacodynamics of BCD-020 with innovator rituximab in patients with indolent non-Hodgkin lymphoma.

Cited by 5 publications

References 0 publications

Biosimilars for the Treatment of Cancer: A Systematic Review of Published Evidence

Biosimilars for the Treatment of Cancer: A Systematic Review of Published Evidence

A clinician’s guide to biosimilars in oncology

First-line therapy of indolent non-Hodgkin’s lymphoma in routine clinical practice

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