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丹麦与其他欧洲国家生物类似药曲妥珠单抗的应用情况比较:一项比较研究及对影响生物类似药应用和采用的因素的讨论

Uptake of biosimilar trastuzumab in Denmark compared with other European countries: a comparative study and discussion of factors influencing implementation and uptake of biosimilars.

机构信息

Department of Clinical Pharmacology, Aalborg University Hospital, Mølleparkvej 4 8a, 9000, Aalborg, Denmark.

Global Supplier & Association Relations, IQVIA, London, UK.

出版信息

Eur J Clin Pharmacol. 2021 Oct;77(10):1495-1501. doi: 10.1007/s00228-021-03155-4. Epub 2021 May 18.

DOI:10.1007/s00228-021-03155-4
PMID:34008071
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8440249/
Abstract

PURPOSE

The aim of this study was to describe the implementation and uptake of biosimilar trastuzumab in Denmark compared with other European countries.

METHODS

European data for usage of trastuzumab was supplied by IQVIA™, using the MIDAS® dataset. A comparison was performed based on market share estimated in sales volume. A separate comparison was undertaken between countries with a full two-fold switch between different biosimilars. Data was collected spanning the time from first registered sales of biosimilar trastuzumab until the 1st quarter of 2020.

RESULTS

Denmark had the fastest and most thorough uptake of biosimilar trastuzumab compared with other EU countries. After 3 months, the market share of biosimilar trastuzumab had increased to 90% while the second fastest country had a 50% market share after 3 months. Only two other countries had undergone a full second switch between biosimilars, Hungary and Norway. All of the three countries made near complete switches between biosimilars while only Denmark had reduced the use of biooriginator below 10%.

CONCLUSION

The implementation of biosimilar trastuzumab in Denmark was rapid and achieved high overall uptake compared with other EU countries. The switch from one biosimilar to another was also achieved quickly and thoroughly. We believe that the rapid dissemination of information and involvement of all stakeholders - administrators, pharmacies, prescribers, nurses, and patients - constitute the backbone of the Danish success. A similar strategy is recommend for biosimilar implementation in other countries.

摘要

目的

本研究旨在描述丹麦与其他欧洲国家相比在曲妥珠单抗生物类似药的实施和采用情况。

方法

IQVIA™ 使用 MIDAS® 数据集提供了曲妥珠单抗使用的欧洲数据。根据销售量估计的市场份额进行了比较。在不同生物类似药之间完全进行两倍转换的国家之间进行了单独比较。数据收集时间跨度从生物类似药曲妥珠单抗首次注册销售到 2020 年第一季度。

结果

与其他欧盟国家相比,丹麦在曲妥珠单抗生物类似药的采用方面速度最快、最彻底。3 个月后,生物类似药曲妥珠单抗的市场份额增加到 90%,而第二快的国家在 3 个月后市场份额达到 50%。只有另外两个国家在生物类似药之间进行了完全的第二次转换,即匈牙利和挪威。这三个国家都几乎完全完成了生物类似药之间的转换,而只有丹麦将生物原研药的使用量降低到 10%以下。

结论

丹麦实施曲妥珠单抗生物类似药的速度很快,与其他欧盟国家相比,总体采用率很高。从一种生物类似药到另一种生物类似药的转换也很快且彻底。我们认为,信息的快速传播和所有利益相关者(行政人员、药剂师、处方者、护士和患者)的参与是丹麦成功的基础。建议在其他国家实施生物类似药时采用类似策略。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/421f/8440249/e9ee27305beb/228_2021_3155_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/421f/8440249/79782d38aaf7/228_2021_3155_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/421f/8440249/3584fce53451/228_2021_3155_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/421f/8440249/e9ee27305beb/228_2021_3155_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/421f/8440249/79782d38aaf7/228_2021_3155_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/421f/8440249/3584fce53451/228_2021_3155_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/421f/8440249/e9ee27305beb/228_2021_3155_Fig3_HTML.jpg

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