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[生物类似药:疗效、安全性及成本评估]

[Biosimilars: assessment of efficacy, safety and cost].

作者信息

Domínguez-Gil Hurlé A

机构信息

Servicio de Farmacia, Hospital Universitario de Salamanca, Salamanca, España.

出版信息

Farm Hosp. 2010 Mar;34 Suppl 1:25-8. doi: 10.1016/S1130-6343(10)70006-4.

Abstract

A biosimilar medicinal product is a successor to a biological medicinal product for which patent protection no longer applies. Manufactured by recombinant DNA technology (insertion of gene into the host cell to produce the protein). Comparable with the selected comparator, reference product, in terms of quality, safety and efficacy. The biosimilar product is usually approved for the same indications as the comparator reference product given that they share the same mode of actions.

摘要

生物类似药是一种生物制品的后续产品,该生物制品的专利保护已不再适用。它通过重组DNA技术(将基因插入宿主细胞以产生蛋白质)制造。在质量、安全性和有效性方面与选定的对照品、参比产品具有可比性。鉴于生物类似药与参比对照产品具有相同的作用方式,通常会被批准用于相同的适应症。

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