Pharmacokinetics and safety of BCD-022, trastuzumab biosimilar candidate, compared to Herceptin in patients.

Стенина, М. Б.; Ignatova, Ekaterina; Фролова, М. А.; Burdaeva, Olga; Nechaeva, Marina; Kopp, Mikhail V.; Udovitsa, Dmitry; Котив, Б. Н.; Алексеев, Сергей; Stroyakovsky, Daniil L.; Sheveleva, Ludmila P.; Khorinko, Andrey V.; Prokopenko, Tatiana I.; Shapovalova, Julia; Jelvakova, Irina A.; Ivanov, Roman; Filon, Olga V.; Tjulandin, Sergei

doi:10.1200/jco.2014.32.15_suppl.e11576

Cited by 9 publications

(9 citation statements)

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“…BCD-022 (Biocad) BCD-022 was evaluated and compared with trastuzumab in a comparative PK substudy in 46 patients with HER2+ metastatic BC [52]. The study was considered to be of excellent quality using the modified Downs and Black instrument.…”

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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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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“…and CT-P6 (Celltrion, Incheon, South Korea), each given in combination with paclitaxel, to originator trastuzumab, also in combination with paclitaxel, in patients with HER2 þ MBC. 75,76 Clinical trials comparing safety and efficacy of these proposed or approved trastuzumab biosimilars in patients with EBC or MBC are ongoing (Table 3). Primary end points include measures of tumor response, such as pCR in the neoadjuvant setting and ORR in the metastatic setting.…”

Section: Kimberly Blackwell Et Almentioning

confidence: 99%

The Global Need for a Trastuzumab Biosimilar for Patients With HER2-Positive Breast Cancer

Blackwell

Gligorov

Jacobs

et al. 2018

Clinical Breast Cancer

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Trastuzumab improves survival outcomes for patients with HER2-positive (HER2) breast cancer, yet not all such women receive this important therapy. Trastuzumab was approved by the US Food and Drug Administration in 1998 and the European Medicines Agency in 2000 as treatment for HER2 metastatic breast cancer (MBC). Observational studies between 2000 and 2015 in patients with HER2 MBC suggest that nearly 12% in the United States, 27% to 54% in Europe, and 27.1% to 49.2% in China did not receive trastuzumab or any other HER2-targeted agent as first- and/or later-line for treatment of metastatic disease. In 2006, both agencies approved trastuzumab as adjuvant therapy for patients with HER2 early breast cancer (EBC). Observational studies on real-world treatment patterns for HER2 EBC between 2005 and 2015 suggest that 19.1% to 59.5% of patients across regions of North America, Europe, Australia, New Zealand, and China did not receive (neo)adjuvant trastuzumab. Data suggest that some patient subgroups, including older patients, those with HER2/hormone receptor-positive disease, and women with small and/or node-negative HER2 tumors, were less likely to receive anti-HER2 therapy. Barriers to accessing trastuzumab are multifactorial and include issues related to drug funding and high treatment costs for patients that have been reported worldwide. Herein, we review available literature on the use of, and barriers to, treatment with trastuzumab in patients with HER2 breast cancer. We also discuss how the availability of safe and effective biosimilars might increase access to trastuzumab and allow greater use of anti-HER2 therapy, potentially improving patient outcomes.

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“…One grade 3 SAE in EU-RP group.NRNo ADA were detectedAbstract 40,41 (FTMB)*No differences in AEs between groups (double-blinded, dose-escalation part). In the open-label part, flu-like symptoms and fatigue more frequently reported for the biosimilar.No signs of cardiotoxicityNo ADA were detectedFull text 47 BCD-022 + (Biocad)No significant differences between groups.NRNRAbstract 38 CT-P6 (Celltrion)SAEs in 15.8% and 20.9% in CT-P6 and RP group, respectively. TEAEs in 40,8% for CT-P6 and 46.3%, for RP group.2.6% cardiotoxicity in CT-P6 group, 7.5% in RP groupNRAbstract 39 DMB-3111 (Meiji Seika)No significant differences between groups.NRNo subjects developed ADAFull text 42 MYL-1401O (Mylan/Biocon)31, 28, 24 subjects experienced in total 227 (91, 80, 56) TEAEs, (mild to moderate in severity) in the biosimilar, EU-RP and US-RP group, respectively.…”

Section: Clinical Data From Phase 1 Trastuzumab Biosimilar Trialsmentioning

confidence: 99%

“…Although EMA guidelines recommend PK testing for mAbs in healthy volunteers, Celltrion and Biocad performed PK testing in HER2+ patients with metastatic breast cancer. 38,39 Other developers, however, followed the EMA guidelines and conducted PK testing for their candidate in healthy volunteers. 40–45 Table 2 provides an overview of the trial parameters and phase 1 PK outcomes for the different biosimilar candidates.…”

Section: Clinical Data From Phase 1 Trastuzumab Biosimilar Trialsmentioning

confidence: 99%

The arrival of biosimilar monoclonal antibodies in oncology: clinical studies for trastuzumab biosimilars

et al. 2019

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The monoclonal antibody trastuzumab (Herceptin®), which targets the human epidermal growth factor receptor 2 (HER2), is approved for the treatment of early breast and advanced breast and gastric cancer in which HER2 is overexpressed. Several biosimilar versions of trastuzumab are expected to enter the European market over the course of 2018 and 2019. The biosimilar development pathway consists of a comprehensive comparability exercise between the biosimilar candidate and the reference product, primarily focussing on data from analytical studies. Clinical studies for biosimilar candidates follow a different design to those for a new biological, as the aim is not to independently establish clinical benefit, but to confirm biosimilarity between the two agents. The different trastuzumab biosimilar candidates have followed diverse pathways in their clinical development, with differences in clinical trial design (equivalence or non-inferiority design), patient population (those with metastatic or early breast cancer) and endpoint (overall response rate or pathological complete response). These differences in approach in phase 3 testing must be viewed in the totality of evidence demonstrating biosimilarity. Adequate information on the biosimilar approval pathway, the nature of the biosimilarity exercise and how the clinical development of a biosimilar is tailored to meet the licensing requirements can help informed decision making in clinical practice.

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Pharmacokinetics and safety of BCD-022, trastuzumab biosimilar candidate, compared to Herceptin in patients.

Cited by 9 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

The Global Need for a Trastuzumab Biosimilar for Patients With HER2-Positive Breast Cancer

The arrival of biosimilar monoclonal antibodies in oncology: clinical studies for trastuzumab biosimilars

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