WHO 药品预认证与检查动态·· 4 天前AI 评分42
WHO 预认证首个甘精胰岛素生物类似药 BT-DM007
First Insulin Glargine biosimilar product prequalified
AI 导读
WHO 预认证单位将甘 & 李制药（PRC）的 BT-DM007 甘精胰岛素注射液 100 U/mL 列入预认证清单，这是首个通过简化预认证路径获批的甘精胰岛素生物类似药，依据为欧洲药品管理局（EMA）授予的上市许可。
正文
News
6 October, 2026 - 00:12 (CEST)
WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
- BT-DM007 Insulin Glargine Solution for injection 100 U/mL – Gan & Lee Pharmaceuticals, PRC.
This is the first biosimilar version of Insulin Glargine prequalified via the abridged prequalification pathway on the basis of the marketing authorization granted by the European Medicines Agency (EMA).
来源：WHO 药品预认证与检查动态 · extranet.who.int