Pharmacokinetics and safety of BCD-021, bevacizumab biosimilar candidate, compared to Avastin in patients.

Orlov, Sergey; Burdaeva, Olga; Nechaeva, Marina; Kopp, Mikhail V.; Котив, Б. Н.; Sheveleva, Ludmila P.; Gladkov, Oleg; Khorinko, Andrey V.; Prokopenko, Tatiana I.; Shapovalova, Julia; Jelvakova, Irina A.; Коваленко, Н. В.; Stroyakovsky, Daniil L.; Pecheniy, Aleksandr P.; Ivanov, Roman; Filon, Olga V.; Tjulandin, Sergei

doi:10.1200/jco.2014.32.15_suppl.e13500

Cited by 11 publications

(10 citation statements)

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“…BCD-021 (Biocad) The PK and safety of BCD-021 were assessed in a comparative trial involving 28 patients with non-squamous NSCLC (stage IIIb/IV) [45]. PK analysis revealed that 90% CIs for the ratio of geometric means of AUC from 0 to 504 h (AUC 0–504h ) of bevacizumab after single BCD-021 and bevacizumab administrations were 80.01–118.28%.…”

Section: Resultsmentioning

confidence: 99%

“…For this reason, the Downs and Black instrument was adapted to assess the quality of the 11 identified abstracts for original studies (Supplementary Fig. S5) [16, 45–47, 50–54, 62, 63]. The average score for abstract publications was 8.5 out of a possible 12 points.…”

Section: Resultsmentioning

confidence: 99%

“…The average score for abstract publications was 8.5 out of a possible 12 points. The total score was fair quality (3–4) for one study [62], good quality (5–8) for two studies [50, 63], and excellent quality (9–12) for eight studies [16, 45–47, 51–54]. The majority of studies published as conference abstracts were of good or excellent quality (90.9%).…”

Section: Resultsmentioning

confidence: 99%

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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%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

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

Jacobs

Ewesuedo

Lula³

et al. 2017

BioDrugs

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“… 48 Examples of emerging potential biosimilars, which are being actively developed according to guidelines and with substantial investments for patients with cancer, include trastuzumab (eg, PF-05280014 [Pfizer Inc, New York, NY, USA], CT-P6 [Celltrion, Incheon City, South Korea], ABP 980 [Amgen Inc, Thousand Oaks, CA, USA], and BCD-022 [BIOCAD, Moscow, Russia] in breast cancer); rituximab (eg, PF-05280586 [Pfizer Inc], GP2013 [Novartis International AG, Basel, Switzerland], BCD-020 [BIOCAD], and RTXM83 [mAbxience SA, Lugano, Switzerland] in non-Hodgkin’s lymphoma); and bevacizumab (eg, PF-06439535 [Pfizer Inc] and BCD-021 [BIOCAD]). 49 – 59 …”

Section: Biosimilars In Developmentmentioning

confidence: 99%

“…Currently, a few manufacturers are accelerating development of potential biosimilar mAbs to full commercial scale production, in compliance with the FDA/EMA standards for biosimilarity, GMP guidelines, and other regulatory requirements. 50 – 59 As recommended, the complexity of biologics and the need to produce them in host-cell systems require careful validation of the multi-step manufacturing process and accurate analytical and biological testing beyond their initial characterization, to ensure consistent safety and efficacy for biosimilars. In addition, monitoring of the final product quality is of particular importance when changes are made in the manufacturing process, the site of production, packaging, or the delivery device.…”

Section: Risk Of Future Biologics Shortagesmentioning

confidence: 99%

Development of biosimilars in an era of oncologic drug shortages

Li¹,

Subramanian²,

Anderson³

et al. 2015

DDDT

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Acute and chronic shortages of various pharmaceuticals and particularly of sterile injectable products are being reported on a global scale, prompting evaluation of more effective strategies to manage current shortages and development of new, high-quality pharmaceutical products to mitigate the risk of potential future shortages. Oncology drugs such as liposomal doxorubicin and 5-fluorouracil represent examples of first-choice drugs critically affected by shortages. Survey results indicate that the majority of hospitals and practicing oncologists have experienced drug shortages, which may have compromised patient safety and clinical outcomes, and increased health care costs, due to delays or changes in treatment regimens. Clinical trials evaluating novel agents in combination with standard-of-care drugs are also being affected by drug shortages. Clinical and ethical considerations on treatment objectives, drug indication, and availability of alternative options may help in prioritizing cancer patients involved in active drug shortages. The United States Food and Drug Administration and the European Medicines Agency have identified manufacturing problems, delays in supply, and lack of available active ingredients as the most frequent causes of recent or ongoing drug shortages, and have released specific guidance to monitor, manage, and reduce the risk of shortages. The upcoming loss of exclusivity for a number of anticancer biologics, together with the introduction of an abbreviated approval pathway for biosimilars, raises the question of whether these products will be vulnerable to shortages. Future supply by reliable manufacturers of well characterized biosimilar monoclonal antibodies, developed in compliance with regulatory and manufacturing guidelines and with substantial investments, may contribute to prevent future biologics shortages and ensure access to effective and safe treatment options for patients with cancer. Preclinical and clinical characterization is ongoing for potential biosimilars of trastuzumab, rituximab, and bevacizumab, with promising results.

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Bevacizumab in Colorectal Cancer: Current Role in Treatment and the Potential of Biosimilars

Rosen¹,

2017

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Colorectal cancer (CRC) is a leading cause of tumor-related morbidity and mortality worldwide, with mortality most often attributable to metastatic disease. Bevacizumab, a humanized monoclonal antibody targeting vascular endothelial growth factor, has a significant role in the treatment of metastatic CRC (mCRC). However, patient access to bevacizumab may be limited in some regions or circumstances, owing to factors related to insurance coverage, reimbursement, patient out-of-pocket costs, or availability. As a result, outcomes for patients with mCRC may be worsened. Additionally, counterfeit bevacizumab has infiltrated legitimate supply chains, exposing patients to risk. Oncologists may also be affected detrimentally, since resolving access issues can be time-consuming and demoralizing. The imminent expiry of patents protecting bevacizumab provides other manufacturers with the opportunity to produce highly similar versions known as biosimilars. High-quality, safe, and effective biosimilars have the potential to expand access to bevacizumab. Most of the bevacizumab biosimilars currently in development are in clinical trials in patients with non-small-cell lung cancer, and future authorization for mCRC indications will, therefore, be based on extrapolation. This article reviews the current role of bevacizumab in the management of mCRC, the possible barriers associated with diminished access to bevacizumab, and the potential bevacizumab biosimilars in development. How biosimilars may impact the treatment of mCRC is also discussed.

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Pharmacokinetics and safety of BCD-021, bevacizumab biosimilar candidate, compared to Avastin in patients.

Cited by 11 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

Development of biosimilars in an era of oncologic drug shortages

Bevacizumab in Colorectal Cancer: Current Role in Treatment and the Potential of Biosimilars

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