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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.

DOI:10.2174/1872208311666171122152131
PMID:29173192
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。

相似文献

1
The Ecstacy of Gold: Patent Expirations for Trastuzumab, Bevacizumab, Rituximab, and Cetuximab.《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》
Recent Pat Biotechnol. 2018;12(2):101-112. doi: 10.2174/1872208311666171122152131.
2
An overview of patents on therapeutic monoclonal antibodies in Europe: are they a hurdle to biosimilar market entry?欧洲治疗性单克隆抗体专利概述:它们是否是生物类似药进入市场的障碍?
MAbs. 2020 Jan-Dec;12(1):1743517. doi: 10.1080/19420862.2020.1743517.
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Current state and comparison of the clinical development of bevacizumab, rituximab and trastuzumab biosimilars.贝伐珠单抗、利妥昔单抗和曲妥珠单抗生物类似药的临床研发现状及比较。
Future Oncol. 2021 Jul;17(19):2529-2544. doi: 10.2217/fon-2020-0923. Epub 2021 Apr 27.
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[The development of biosimilars in oncology].[肿瘤学中生物类似药的发展]
Zhonghua Zhong Liu Za Zhi. 2017 Oct 23;39(10):721-725. doi: 10.3760/cma.j.issn.0253-3766.2017.10.001.
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Clinical development of CT-P10 and other biosimilar cancer therapeutics.CT-P10及其他生物类似药癌症治疗药物的临床开发
Future Oncol. 2017 May;13(15s):31-44. doi: 10.2217/fon-2017-0155.
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New frontiers in oncology: biosimilar monoclonal antibodies for the treatment of breast cancer.肿瘤学新前沿:用于治疗乳腺癌的生物类似单克隆抗体。
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A descriptive analysis of real-world oncology biosimilar use in Japan.日本真实世界肿瘤生物类似药使用情况的描述性分析。
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Pharmacist perspectives and considerations for implementation of therapeutic oncology biosimilars in practice.药师在实践中实施治疗性肿瘤生物类似药的观点和考虑因素。
Am J Health Syst Pharm. 2019 Oct 15;76(21):1725-1738. doi: 10.1093/ajhp/zxz190.
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What Does the Pipeline Promise about Upcoming Biosimilar Antibodies in Oncology?生物药研发管线对即将上市的肿瘤学领域生物类似药抗体有何展望?
Breast Care (Basel). 2019 Mar;14(1):10-16. doi: 10.1159/000496834. Epub 2019 Feb 13.
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Efficacy and Safety of Anti-cancer Biosimilars Compared to Reference Biologics in Oncology: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.抗癌生物类似药与肿瘤学参照生物制剂相比的疗效和安全性:随机对照试验的系统评价和荟萃分析。
BioDrugs. 2019 Aug;33(4):357-371. doi: 10.1007/s40259-019-00358-1.

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Animals (Basel). 2023 Aug 3;13(15):2507. doi: 10.3390/ani13152507.
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Nanotherapeutics Plus Immunotherapy in Oncology: Who Brings What to the Table?肿瘤学中的纳米治疗与免疫疗法:各自发挥什么作用?
Pharmaceutics. 2022 Oct 28;14(11):2326. doi: 10.3390/pharmaceutics14112326.
3
Overcoming malignant cell-based mechanisms of resistance to immune checkpoint blockade antibodies.
克服免疫检查点阻断抗体耐药的恶性细胞机制。
Semin Cancer Biol. 2020 Oct;65:28-37. doi: 10.1016/j.semcancer.2019.12.005. Epub 2019 Dec 19.
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Inhibiting exosomal MIC-A and MIC-B shedding of cancer cells to overcome immune escape: new insight of approved drugs.抑制癌细胞外泌体 MIC-A 和 MIC-B 的脱落以克服免疫逃逸:已批准药物的新见解。
Daru. 2019 Dec;27(2):879-884. doi: 10.1007/s40199-019-00295-y. Epub 2019 Aug 21.
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Access to high-cost drugs for advanced breast cancer in Latin America, particularly trastuzumab.拉丁美洲晚期乳腺癌患者获取高成本药物的情况,尤其是曲妥珠单抗。
Ecancermedicalscience. 2019 Jan 22;13:898. doi: 10.3332/ecancer.2019.898. eCollection 2019.