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阿根廷、澳大利亚、巴西和意大利的生物类似药定价的跨国比较。

A Cross-National Comparison of Biosimilars Pricing in Argentina, Australia, Brazil, and Italy.

机构信息

Instituto de Ciências Farmacêuticas, Universidade Federal Do Rio de Janeiro, Macaé, Rio de Janeiro, Brazil.

Sorocaba University, Sorocaba, São Paulo, Brazil.

出版信息

Ther Innov Regul Sci. 2024 May;58(3):549-556. doi: 10.1007/s43441-024-00623-8. Epub 2024 Mar 4.

Abstract

BACKGROUND

Biosimilar medicines are defined as biological products highly similar to an already licensed biological product (RP). The market entry of biosimilars is expected to reduce the costs of biological treatments.

OBJECTIVE

This study aims to evaluate the range of differences between the prices of biosimilars and the corresponding RP for biologicals approved in four countries.

METHOD

This is a cross-national comparison of pricing of biosimilars in Argentina, Australia, Brazil, and Italy. The study examined online price databases provided by the national authorities of the investigated countries. Biosimilar price difference was calculated by subtracting the unit price of the biosimilar by the unit price of the RP, and then dividing it by the unit price of the RP. The results were presented as percentage.

RESULTS

Brazil had the highest median price reduction (- 36.3%) in biosimilars price, followed by Italy (- 20.0%) and Argentina (- 18.6%). All the biosimilars in Italy were priced below the RP presenting a minimum reduction of 6.3%, while in Australia, most of the prices of biosimilars were equal to the RP. In Argentina, one infliximab-biosimilar displayed price above the RP (40.7%) while the lower priced brand had a reduction of 14.4%. Brazil had four biosimilars with prices above the respective RP, including isophane insulin (1), insulin glargine (1) and somatropin (2).

CONCLUSION

The study revealed a marked dispersion in the price's differences between biosimilars and RP across the studied countries. Governments should evaluate whether their policies have been successful in improving affordability of biological therapies.

摘要

背景

生物类似药被定义为与已获批的生物制品(参照药)高度相似的生物制品。预计生物类似药的上市将降低生物治疗的成本。

目的

本研究旨在评估四个国家批准的生物类似药与相应参照药之间价格差异的范围。

方法

这是对阿根廷、澳大利亚、巴西和意大利四国生物类似药定价的跨国比较。研究考察了所调查国家的国家当局提供的在线价格数据库。通过用生物类似药的单价减去参照药的单价,然后除以参照药的单价来计算生物类似药价格差异。结果以百分比表示。

结果

巴西的生物类似药价格降幅最高(-36.3%),其次是意大利(-20.0%)和阿根廷(-18.6%)。意大利所有的生物类似药价格均低于参照药,降幅最小为 6.3%,而在澳大利亚,大多数生物类似药的价格与参照药持平。在阿根廷,有一种英夫利昔单抗生物类似药的价格高于参照药(40.7%),而价格较低的品牌降价幅度为 14.4%。巴西有四种生物类似药的价格高于相应的参照药,包括单组分胰岛素(1 种)、甘精胰岛素(1 种)和生长激素(2 种)。

结论

研究表明,在所研究的国家中,生物类似药与参照药之间的价格差异存在显著差异。政府应评估其政策是否成功地提高了生物治疗的可负担性。

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