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贝伐单抗生物类似药会影响妇科癌症全身治疗的价值吗?

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

作者信息

Monk Bradley J, Huh Warner K, Rosenberg Julie Ann, Jacobs Ira

机构信息

Arizona Oncology (US Oncology Network), University of Arizona College of Medicine, Creighton University School of Medicine at St. Joseph's Hospital, Phoenix, AZ USA.

University of Alabama at Birmingham, Birmingham, AL USA.

出版信息

Gynecol Oncol Res Pract. 2017 Mar 21;4:7. doi: 10.1186/s40661-017-0045-x. eCollection 2017.

DOI:10.1186/s40661-017-0045-x
PMID:28344818
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5361700/
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.

摘要

目的

贝伐单抗是多种癌症治疗中的重要组成部分,尽管指南推荐其用于卵巢癌和宫颈癌的治疗,但患者获得贝伐单抗和其他血管生成抑制剂的机会有限。生物类似药是大型、结构复杂的分子,旨在与现有的已获许可或批准的(参照)生物制品高度相似,并治疗相同病症,在纯度、效力和安全性方面无临床意义上的差异。本文总结了贝伐单抗在卵巢癌和宫颈癌治疗模式中的作用。我们还讨论了贝伐单抗生物类似药的潜在作用,其可能在未来妇科癌症治疗中提供更经济实惠的选择。

方法

对PubMed和ClinicalTrials.gov数据库进行了文献检索。还查阅了监管机构和各制药公司的网页。检索词包括“生物类似药”和“贝伐单抗”,用于识别有关生物类似药研发、报告生物类似药研究结果或处于研发阶段的生物类似药的信息。

结果

目前,有四种贝伐单抗生物类似药候选药物正在进行比较临床评估,有可能增加可及性并提高整个医疗系统的效率。

结论

预计贝伐单抗等生物制品将继续在一系列妇科癌症的治疗中发挥关键作用。贝伐单抗生物类似药目前正在研发中,有可能在包括妇科癌症在内的多种情况下增加药物可及性。

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