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[肿瘤学中生物类似药的发展]

[The development of biosimilars in oncology].

作者信息

Jiang S Y, Shi Y K

机构信息

Department of Medical Oncology, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China.

出版信息

Zhonghua Zhong Liu Za Zhi. 2017 Oct 23;39(10):721-725. doi: 10.3760/cma.j.issn.0253-3766.2017.10.001.

DOI:10.3760/cma.j.issn.0253-3766.2017.10.001
PMID:29061013
Abstract

With the extensive application in clinical practice, biological medicine plays a significant role in both treatment and supportive care in oncology. With the expiration of original drug patents, biosimilars emerge. The biosimilars are defined as biological drugs that are be highly similar but not identical to the biological reference. Their development and evaluation procedure are different from those of small molecular chemical generics. Biosimilars are expected to reduce the health care costs worldwide. The booming developments of biosimilars, such as rituximab, trastuzumab and bevacizumab in medical oncology can optimize the clinical strategies, offer patients more treatment options and reduce the medical expenditure. In this article, we review the advances in the field of biosimilars, especially focus on the challenges and opportunities of biosimilars in clinical oncology.

摘要

随着生物医药在临床实践中的广泛应用,其在肿瘤学的治疗和支持性护理中都发挥着重要作用。随着原研药物专利的到期,生物类似药应运而生。生物类似药被定义为与生物参照药高度相似但并非完全相同的生物药物。它们的研发和评估程序与小分子化学仿制药不同。生物类似药有望降低全球医疗保健成本。利妥昔单抗、曲妥珠单抗和贝伐单抗等生物类似药在肿瘤医学中的蓬勃发展可以优化临床策略,为患者提供更多治疗选择并降低医疗支出。在本文中,我们综述了生物类似药领域的进展,尤其关注生物类似药在临床肿瘤学中的挑战与机遇。

相似文献

1
[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.
2
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 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.
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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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The Economic Impact of Biosimilars in Oncology and Hematology: The Case of Trastuzumab and Rituximab.生物类似药在肿瘤学和血液学领域的经济影响:以曲妥珠单抗和利妥昔单抗为例。
Anticancer Res. 2019 Jul;39(7):3971-3973. doi: 10.21873/anticanres.13552.
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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。
Future Oncol. 2024;20(25):1837-1850. doi: 10.1080/14796694.2024.2352405. Epub 2024 Jun 12.
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Introduction and commentary: Paving the way for biosimilars in oncology.引言与评论:为肿瘤学中的生物类似药铺平道路
Semin Oncol. 2013 Dec;40 Suppl 1:S1-4. doi: 10.1053/j.seminoncol.2013.09.014. Epub 2013 Oct 4.
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Current situation and challenges regarding biosimilars in Japan: an example of trastuzumab biosimilars for breast cancer.在日本,生物类似药的现状和挑战:以曲妥珠单抗生物类似药治疗乳腺癌为例。
Future Oncol. 2019 Apr;15(12):1353-1361. doi: 10.2217/fon-2018-0957. Epub 2019 Feb 15.
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Improving oncology biosimilar launches in the EU, the USA, and Japan: an updated Policy Review from the Southern Network on Adverse Reactions.改善欧盟、美国和日本的肿瘤生物类似药上市情况:不良反应南方网络的最新政策回顾。
Lancet Oncol. 2020 Dec;21(12):e575-e588. doi: 10.1016/S1470-2045(20)30485-X.
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[Biosimilar drugs in oncology].[肿瘤学中的生物类似药]
Bull Cancer. 2016 Mar;103(3):294-8. doi: 10.1016/j.bulcan.2015.12.004. Epub 2016 Jan 29.

引用本文的文献

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Bevacizumab biosimilar LY01008 compared with bevacizumab (Avastin) as first-line treatment for Chinese patients with unresectable, metastatic, or recurrent non-squamous non-small-cell lung cancer: A multicenter, randomized, double-blinded, phase III trial.贝伐珠单抗生物类似药 LY01008 对比贝伐珠单抗(安维汀)一线治疗中国不可切除、转移性或复发性非鳞状非小细胞肺癌患者的多中心、随机、双盲、III 期临床试验。
Cancer Commun (Lond). 2021 Sep;41(9):889-903. doi: 10.1002/cac2.12179. Epub 2021 Jun 29.