生物相似性藥品之臨床使用考量

Introduction and Clinical Considerations for Biosimilars

陳立奇(Lih-Chi Chen)

《北市醫學雜誌》 17卷2期 (2020/06) Pp. 174-180

https://doi.org/10.6200/TCMJ.202006_17(2).0004

摘要

近年來，隨著許多原開發生物製劑的專利陸續到期，他廠可以開始後繼研發上市所謂的「生物相似性藥品」，挾其藥價相對便宜之價格優勢，確實為藥物經濟提供了不錯的新選項。但由於生物製劑通常是大分子的蛋白質製劑，結構複雜且多樣，具有高度的複雜性及特異性，其臨床應用的角色定位及面臨的挑戰，如適應症之外推、互換性、命名方式以及藥物監視等，在各國的審查及管理法規仍不盡相同的情況下，仍待更多實務驗證及討論共識。建議臨床在評估新進及選擇使用生物相似藥品時，除考量藥物經濟之效益外，亦須審慎評估藥物品質的穩定度、臨床療效的確認及落實藥品使用安全性之監視等，確保病人治療用藥之療效及安全。

關鍵字

生物相似性藥品 ； 臨床使用 ； 考量

並列摘要

Over the last few years, as many patents for original biological agents have subsequently expired, the so-called ＂biosimilars＂ generic drugs have been developed and put on market. With their relatively cheaper prices, they have provided good alternatives in clinical practice considering cost-effectiveness. Since biological agents are usually prepared by using a large amount of proteins and the structure is complicated and diverse, their clinical roles and challenges such as extrapolation of indications, interchangeability, nomenclature, and drug monitoring, are still to be validated and consensus to be reached under dissimilar review and regulations in different countries. Apart from the cost-effectiveness in pharmacoeconomics, it is recommended to assess the quality stability, confirm the clinical efficacy, and implement the monitoring of drug safety during the evaluation of new coming or selection of ＂biosimilars＂ to ensure drug efficacy and safety.

並列關鍵字

biosimilars ； clinical use ； consideration