特立帕肽生物类似药的研发考虑  

Considerations on research and development of teriparatide biosimilars

作　　者：阚红金 韦薇 程速远 KAN Hong-jin;WEI Wei;CHENG Su-yuan(Center for Drug Evaluation,National Medical Products Administration,Beijing 100076,China)

机构地区：[1]国家药品监督管理局药品审评中心,北京100076

出　　处：《中国新药杂志》2025年第6期643-649,共7页Chinese Journal of New Drugs

摘　　要：特立帕肽是开发较早的多肽类药物,随着原研药专利到期,正逐渐成为研发热点,国内医药企业按照生物类似药开发的特立帕肽生物类似药逐年增多。本文梳理了特立帕肽原研药及生物类似药国内外注册研发现状、监管现状、用药情况,分析了特立帕肽生物类似药研发技术要求及挑战,并对此类产品药学开发中的常见技术问题进行探讨,以期为此类生物类似药的药学开发和评价提供参考。Teriparatide is a peptide drug developed earlier.With the patent expiration of the original drug,its biosimilar is gradually becoming a hot spot for research and development(R&D),and the number of teriparatide biosimilars developed by domestic pharmaceutical companies is gradually increasing.In this paper,we have sorted out the domestic and international registration and R&D status,regulatory status,and use of teriparatide originator and biosimilars,analyzed the technical requirements and challenges of teriparatide biosimilar R&D,and explored the common technical problems in the pharmaceutical development of this kind of products,with a view to providing references to the pharmaceutical development and evaluation of this kind of biosimilars.

关 键 词：重组来源 多肽 特立帕肽 生物类似药 

分 类 号：R979.9[医药卫生—药品]