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First Insulin Glargine biosimilar product prequalified

News
6 October, 2026 - 00:12 (CEST)
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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).