第一个仿制药Teriparatide:与其参考药品的结构和生物相似性
Jimena Fernández-Carneado1, Mariona Vallès-Miret1, Sílvia Arrastia-Casado1
1BCN Peptides SA, 08777 Barcelona, Spain.
Pharmaceutics
|April 27, 2024
概括
合成特里巴化物BGW在结构和生物学上与参考药物相当. 这表明了基本的相似性,为第一种用于治疗骨质疏松症的仿制药铺平了道路.
科学领域:
- 制药科学 制药科学
- 生物化学 生物化学
背景情况:
- 骨质疏松症的治疗依赖于类固醇类药物,如teriparatide.
- 再组合特里巴化物于2002年获得批准,随后开发了生物类似物和混合物替代品.
- 通用药物开发需要证明与参考药物 (RMP) 的基本相似性.
研究的目的:
- 为了确定合成特里巴化物BGW和RMP之间的基本相似性.
- 支持开发第一个仿制性特里巴类药物.
- 为了确保骨质疏松症患者的可比疗效和安全性.
主要方法:
- 使用了全面的并排比较分析.
- 采用最先进的直角方法进行结构和生物评估.
- 包括核磁共振 (NMR),离子移动性质谱 (IM-MS),UV-Vis,循环二极化 (CD) 和里埃变换红外 (FTIR) 光谱.
- 进行了基于细胞的比较生物测试,以评估生物活性.
主要成果:
- 结构分析 (NMR,IM-MS,UV,CD,FTIR) 证实了teriparatide BGW和RMP之间的结构相同性.
- 基于细胞的生物测试表明合成和重组的生物行为相同.
- 在结构性或功能性特征方面没有观察到显著差异.
结论:
- 特里巴拉提德BGW与参考药物基本相似.
- 这一发现支持teriparatide BGW作为骨质疏松症治疗的可行通用替代品.
- 该仿制药与RMP具有相同的临床益处,增加了患者获得有效的骨质疏松症治疗的机会.
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