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

Gynecologic oncology research and practice Pub Date : 2017-03-21 eCollection Date: 2017-01-01 DOI:10.1186/s40661-017-0045-x
Bradley J Monk, Warner K Huh, Julie Ann Rosenberg, Ira Jacobs
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引用次数: 5

Abstract

Objective: Bevacizumab 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.

Methods: Literature 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.

Results: At present, four bevacizumab biosimilar candidates are undergoing comparative clinical assessment, with the potential to increase access and offer efficiencies across healthcare systems.

Conclusions: It 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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贝伐单抗生物仿制药会影响妇科癌症全身治疗的价值吗?
目的:贝伐珠单抗是多种癌症治疗的重要组成部分,尽管指南建议将其用于卵巢癌和宫颈癌,但患者获得贝伐珠单抗和其他血管生成抑制剂的途径有限。生物仿制药是结构复杂的大分子,旨在与现有许可或批准的(参考)生物制剂高度相似,治疗相同的病症,在纯度、效力和安全性方面没有临床意义上的差异。本文总结了贝伐单抗在卵巢癌和宫颈癌治疗范例中的作用。我们还讨论了贝伐单抗生物仿制药的潜在作用,这可能为未来妇科癌症的治疗提供更实惠的选择。方法:检索PubMed和ClinicalTrials.gov数据库的文献。监管机构和个别制药公司的网页也进行了审查。搜索词包括“生物类似药”和“贝伐单抗”,这些用于识别有关生物类似药开发的信息,报告生物类似药研究结果或正在开发的生物类似药。结果:目前,四种贝伐单抗候选生物类似药正在进行比较临床评估,具有增加医疗保健系统可及性和提高效率的潜力。结论:预计贝伐单抗等生物制剂将继续在一系列妇科癌症的治疗中发挥关键作用。贝伐单抗的生物仿制药目前正在开发中,有可能增加各种情况下药物的可及性,包括妇科癌症。
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