Posted by Michael Wonder on 08 Oct 2023
Biocon biologics receives complete response letter from US FDA for biosimilar insulin aspart
7 October 2023 - The US FDA has issued a complete response letter for the biologics license application for insulin aspart.
The complete response letter did not identify any outstanding scientific issues with the product. The complete response letter references the requirement for a satisfactory resolution of deficiencies from the pre-approval inspection of our Malaysia facility for insulin aspart, held in August 2022.
