The US FDA issues a complete response letter for the biologics license application for insulin aspart

Biocon

7 January 2022 - The U.S. FDA has issued a complete response letter for the biologics license application for insulin aspart filed by Viatris (Mylan). 

The complete response letter did not identify any outstanding scientific issues with the product.

Read Biocon Statement

Michael Wonder

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Michael Wonder

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Outcome , Medicine , US , Biosimilar , Dossier