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REGULATORY UPDATE
First Insulin Glargine biosimilar product prequalified
Published: 10/6/2026Detected: 10/6/2026

Summary preview

Adds a first insulin glargine biosimilar (BT-DM007) to WHO prequalification, establishing that approval under the EMA abridged pathway can support WHO prequalification for this product.

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pediatrics
immunology
neurology
#WHO prequalification
#biosimilar
#insulin glargine
#abridged prequalification pathway
#EMA marketing authorization

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