Efficacy and safety of BCD-021, bevacizumab biosimilar candidate, compared to Avastin: Results of international multicenter randomized double blind phase III study in patients with advanced non-squamous NSCLC.

Filon, Olga V.; Orlov, Sergey; Burdaeva, Olga; Kopp, Mikhail V.; Котив, Б. Н.; Алексеев, Сергей; Pecheniy, Aleksandr P.; Stroyakovskiy, Daniil; Gladkov, Oleg; Khorinko, Andrey V.; Matrosova, Marina; Galiulin, Rinat; Скопин, П. И.; Mukhametsina, Guzel; Odarchenko, Sergey; Kulik, Sergey A.; Kulyaba, Jaroslav; Adamchuk, Grigory; Vinnyk, Y.; Tjulandin, Sergei

doi:10.1200/jco.2015.33.15_suppl.8057

Cited by 12 publications

(15 citation statements)

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“…Among the indications of BEV for the treatment of various types of cancers, the efficacy comparative studies between all proposed BEV biosimilars and RMP were performed in patients with advanced non-small-cell lung cancer in combination with paclitaxel and carboplatin (P + C) as standard chemotherapy [41][42][43][44][45][46][47][48].…”

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

confidence: 99%

“…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]. Celltrion Healthcare conducted an equivalence and in a noninferiority trial as part of the clinical program of its RTX candidate, CT-P10 [51,52].…”

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

confidence: 99%

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

confidence: 99%

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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show abstract

“…56 BCD-021, another biosimilar of bevacizumab, has demonstrated non-inferiority to reference brand Avastin among patients having NSCLC. 57 After a single dose administration through intravenous route, the safety and pharmacokinetic properties of biosimilar BCD-021 and reference Avastin was examined to be identical and this data permits to pursue the BCD-022 study which is basically aimed to evaluate effectiveness and safety parameters in the same population. 58 Bevacizumab is effective in treating several types of tumor.…”

Section: Bevacizumabmentioning

confidence: 99%

Progress in oncology biosimilars till 2020: Scrutinizing comparative studies of biosimilar monoclonal antibodies

Safdar

Butt

Ahmad

et al. 2021

J Oncol Pharm Pract

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Stupendous elevation in the healthcare costs has followed with the inception of the current unconventional options of treatment available for cancer patients. There is a dire need of innovative financing approaches to lessen the financial load on healthcare system. Biosimilars are biological drugs consisting of an active ingredient from a reference biological drug that has a great potential of relieving financial load. Strict requirements from regulatory point of view are required as biosimilars are exceedingly similar to but not identical to the reference product. This provides with a certainty that no consequential differences from clinical point of view as compared to the respective biologics exists with regards to efficacy, safety and purity. Safety and effectiveness of biosimilars have been disclosed since more than 10 years of affirmations. However, there is a need to educate the healthcare professionals to abolish potential misconceptions and coalesce biosimilars into regular clinical practice. The present review focuses on providing an overview of regulatory aspects and requirements for biosimilars, the main challenges in the selection and development of biosimilars and the economic impact and financial savings observed in recent studies carried out in different parts of the world. In addition, we have discussed the different successful comparative studies which have been done in different parts of the world to depict the biosimilarity for monoclonal antibodies such as bevacizumab, trastuzumab and rituximab.

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“…BCD-021 (Biocad) showed similar PK and safety to bevacizumab in patients with NSCLC [ 21 ]. BCD-021 also demonstrated similar efficacy, safety and immunogenicity to bevacizumab in patients with advanced non-squamous NSCLC [ 22 ]. A multicenter, randomized, double-blind clinical trial is ongoing to evaluate the efficacy and safety of BI 695502 (Boehringer Ingelheim) compared with bevacizumab (in combination with chemotherapy) in patients with advanced non-squamous NSCLC (ClinicalTrials.gov, NCT02272413).…”

Section: Reviewmentioning

confidence: 99%

Will bevacizumab biosimilars impact the value of systemic therapy in gynecologic cancers?

Monk

Huh

Rosenberg

et al. 2017

gynaecol oncol res pract

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ObjectiveBevacizumab is an important component in the treatment of various cancers, and despite guidelines recommending its use in both ovarian and cervical cancer, patient access to bevacizumab and other angiogenesis inhibitors is limited. Biosimilars are large, structurally complex molecules that are intended to be highly similar to, and treat the same condition(s) as, an existing licensed or approved (reference) biologic, with no clinically meaningful differences in purity, potency and safety. This article summarizes the role of bevacizumab in the treatment paradigm of ovarian and cervical cancer. We also discuss the potential role of biosimilars to bevacizumab, which may offer more affordable options in the future treatment of gynecologic cancers.MethodsLiterature searches of PubMed and ClinicalTrials.gov databases were conducted. Regulatory and individual pharmaceutical company web pages were also reviewed. Search terms included “biosimilar” and “bevacizumab,” and these were used to identify information regarding biosimilar development, reporting results of biosimilar studies or biosimilars in development.ResultsAt present, four bevacizumab biosimilar candidates are undergoing comparative clinical assessment, with the potential to increase access and offer efficiencies across healthcare systems.ConclusionsIt is anticipated that biologics such as bevacizumab will continue to play a key role in the treatment of an array of gynecologic cancers. Biosimilars to bevacizumab are currently in development and have the potential to increase access to medicines in a variety of settings, including gynecologic cancers.

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Efficacy and safety of BCD-021, bevacizumab biosimilar candidate, compared to Avastin: Results of international multicenter randomized double blind phase III study in patients with advanced non-squamous NSCLC.

Cited by 12 publications

References 0 publications

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

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

Progress in oncology biosimilars till 2020: Scrutinizing comparative studies of biosimilar monoclonal antibodies

Will bevacizumab biosimilars impact the value of systemic therapy in gynecologic cancers?

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