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《黄金的狂喜:曲妥珠单抗、贝伐单抗、利妥昔单抗和西妥昔单抗的专利到期》

The Ecstacy of Gold: Patent Expirations for Trastuzumab, Bevacizumab, Rituximab, and Cetuximab.

作者信息

Serna-Gallegos Tasha R, La-Fargue Christopher J, Tewari Krishnansu S

机构信息

Department of Obstetrics and Gynecology, University of California, Irvine-Medical Center, Orange, CA, United States.

Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of California, Irvine-Medical Center, Orange, CA, United States.

出版信息

Recent Pat Biotechnol. 2018;12(2):101-112. doi: 10.2174/1872208311666171122152131.

Abstract

OBJECTIVE

Fully humanized monoclonal antibodies have revolutionized the treatment of many solid tumors, including ovarian, lung, colorectal, and breast cancer. Among the most widely used monoclonal antibodies in clinical oncology are cetuximab, trastuzumab, rituximab, and bevacizumab.

METHODS

This is a review article focusing on the drug patents for cetuximab, trastuzumab, rituximab, and bevacizumab.

RESULTS

These four monoclonal antibodies are used in both first and second line treatment regimens for multiple common malignancies. With recent patent expirations, pharmaceutical companies involved in biosimilar manufacture are looking to establish ownership over these financial monopolies.

CONCLUSION

This article will review these four notable monoclonal antibodies, their role in clinical oncology, and the drug patents that are nearing expiration. There are currently only two biosimilars approved in the United States: the trastuzumab biosimilar trastuzumab-dkst (Ogivri) and the bevacizumab biosimilar bevacizumab-awwb (Mvasi). In Europe, SB3, a trastuzumab biosimilar, is approved for use as well as two rituzimab biosimilars, truxima and rixathon.

摘要

目的

全人源单克隆抗体彻底改变了许多实体瘤的治疗方式,包括卵巢癌、肺癌、结直肠癌和乳腺癌。临床肿瘤学中使用最广泛的单克隆抗体包括西妥昔单抗、曲妥珠单抗、利妥昔单抗和贝伐单抗。

方法

这是一篇综述文章,重点关注西妥昔单抗、曲妥珠单抗、利妥昔单抗和贝伐单抗的药物专利。

结果

这四种单克隆抗体用于多种常见恶性肿瘤的一线和二线治疗方案。随着近期专利到期,参与生物类似药生产的制药公司希望确立对这些经济垄断的所有权。

结论

本文将综述这四种著名的单克隆抗体、它们在临床肿瘤学中的作用以及即将到期的药物专利。目前美国仅批准了两种生物类似药:曲妥珠单抗生物类似药曲妥珠单抗-dkst(Ogivri)和贝伐单抗生物类似药贝伐单抗-awwb(Mvasi)。在欧洲,曲妥珠单抗生物类似药SB3以及两种利妥昔单抗生物类似药truxima和rixathon已获批使用。

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