生物相似性藥品到底有多相像呢？

生物製藥業近20年快速發展，使其成為傳統製藥外另一個舉足輕重產業。生物相似性藥品（biosimilars）是近年來藥界崛起新星及新治療領域，隨著許多原開發生物製劑的專利陸續到期，他廠開始後繼研發上市所謂的「生物相似性藥品」，因藥價相對便宜之優勢，確實為藥物經濟提供新選項，其中尤以抗癌用藥為重點，此現象提供癌症病人更多用藥選擇。由於生物製劑通常是大分子的蛋白質製劑，具有高度複雜性及特異性，其臨床應用角色定位及面臨的挑戰，如適應症外推、互換性、命名方式以及藥物監測等，各國審查及管理法規不盡相同，仍待更多實務驗證及討論。建議臨床評估新進及選擇使用生物相似性藥品時，除考量藥物經濟效益外，亦須審慎評估品質穩定度、臨床療效及安全性之監測等，確保病人用藥療效及安全。

關鍵字

生物相似性藥品；法規；挑戰

並列摘要

The rapid development of the biopharmaceutical industry in the past two decades has made it an important industry besides traditional pharmaceuticals. Biosimilars are a rising star in the pharmaceutical industry and new therapeutic areas in recent years. As many patents for originally developed biological agents expired one after another, other factories can begin to develop and market so-called ＂biosimilar drugs＂. The relatively cheaper price advantage does provide new options for the drug economy. The focus is on anti-cancer drugs to provide cancer patients with more choices. Owing to biological agents are usually large molecular protein preparations with a high degree of complexity and specificity, they face role positioning in clinical applications and challenges, such as extrapolation of indications, interchangeability, naming methods, and drug monitoring. The censorship and management regulations are not the same in each country, it needs more practical verification and discussion to reach consensus. It is recommended that when evaluating new and selecting biosimilars, clinicians should not only consider the economic benefits of the drugs, but also carefully evaluate the stability of the drug quality, confirm the clinical efficacy, and implement the monitoring of drug safety to ensure the efficacy and safety of the drugs used by patients.

並列關鍵字

biosimilars ； regulations ； challenges

參考文獻

Urquhart L. Top drugs and companies by sales in 2018. Nat Rev Drug Discov 2019 Mar 12. doi: 10.1038/d41573-019-00049-0. Online ahead of print. doi: 10.1038/d41573-019-00049-0

Agbogbo FK, Ecker DM, Farrand A, et al. Current perspectives on biosimilars. J Ind Microbiol Biotechnol 2019;46:1297-311. doi: 10.1007/s10295-019-02216-z

Kesik-Brodacka M. Progress in biopharmaceutical development. Biotechnol Appl Biochem 2018;65:306-22. doi: 10.1002/bab.1617

Lyman GH, Balaban E, Diaz M, et al. American Society of Clinical Oncology Statement: Biosimilars in oncology. J Clin Oncol 2018;36: 1260-5. doi: 10.1200/JCO.2017.77.4893

Thill M, Thatcher N, Hanes, V, et al. Biosimilars: what the oncologist should know. Future Oncol 2019;15:1147-65. doi: 10.2217/fon-2018-0728

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生物相似性藥品到底有多相像呢？

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