臺灣生物相似性藥品之法規與臨床考量

Regulatory and Practical Considerations of Biosimilar Products in Taiwan

林婉婷(Wan-Ting Lin) ； 林慧玲(Fe-Lin Lin Wu) ； 沈麗娟(Li-Jiuan Shen) ； 蘇錦玲(Chin-Ling Su)

《臺灣臨床藥學雜誌》 27卷2期 (2019/04) Pp. 83-90

https://doi.org/10.6168/FJCP.201904_27(2).0001

摘要

生物製劑（biologics）有別於一般由化學合成或由天然物純化而得的小分子藥品（small molecule drugs），為大分子藥品，其製程主要來源為微生物或細胞，每個步驟差異皆可能影響藥品品質。當原開發廠生產的生物製劑（originator products）專利期結束，市面上開始出現類似學名藥概念的生物相似性藥品（biosimilar products）。因各家藥廠生產的生物製劑來源與製程不盡相同，生物相似性藥品與原廠藥品必然存在些微差異，惟此差異預期不會明顯影響臨床效果。在審查方面，生物相似性藥品藉由與原開發廠生物藥品的各種比較證實此兩種產品為高度相似，間接證實其療效及安全性。生物相似性藥品於安全性部分另有特別要求（上市後的藥物安全監視計畫、風險管理計畫等）。隨著生物相似性藥品使用範圍的增加，醫院藥局對於藥品選擇進用及調劑之考量，益顯重要。基於藥品管理與病人用藥安全，本文介紹目前生物相似性藥品相關法規內容，如：藥品命名、仿單、藥品包裝與適應症等，討論醫療院所端在藥品進用與替換時的考量與疑慮，提高藥師對生物相似性藥品的認知，與時俱進提供必要藥品資訊以確保生物相似性藥品使用的適切性，進而在選擇進用藥品時能有更好的判斷，提供病人更好的醫療選擇和品質。

關鍵字

生物相似性藥品 ； 法規 ； 藥師 ； 臨床考量

並列摘要

Different from small molecule drugs which are synthesized chemically or purified from natural medicines, biologics are large molecule drugs manufactured mainly in a microorganism or cells and the quality is influenced by the manufacturing process. When the patent of originator products expires, many similar products called ＂biosimilar products＂ will be available. Because of the differences in the biological source and the manufacturing process, minor differences exist between the originator product and the biosimilar one. However, these differences may not be clinically significant. The high bio-similarity demonstrated by comprehensive comparative studies with the originator product could be used to approve the effectiveness and safety of the biosimilars. Further safety assessments, such as the post-market pharmacovigilance or risk management plan, are required for biosimilars. With the increasing availability of biosimilars, assessment during drug selection, procurement, and dispensing are critical for hospital pharmacy. For medication safety and management of biosimilar products, this article reviewed the regulations on biosimilars, such as drug nomenclature, labeling, package, and indications; as well as hospitals' concerns over selection and substitution of biosimilars. We hope that this article can enhance pharmacists' knowledge in biosimilars, so they can provide necessary information to ensure the appropriate use of biosimilars and a better judgement in product selection, thereby facilitate better services to patients.

並列關鍵字

Biosimilar Products ； Regulatory ； Pharmacist ； Clinical Practice