Biocon Receives Another FDA Setback On Insulin Aspart

Further Complete Response Letter Issued After Inspection Not Scheduled Ahead Of Goal Date

 
• By Dave Wallace

Biocon has announced receipt of another CRL from the FDA relating to its insulin aspart biosimilar application, after the agency failed to schedule a reinspection of the firm’s Malaysia facility ahead of the latest goal date.

Sign outside of FDA's headquarters in White Oak, MD
The FDA did not schedule a reinspection ahead of Biocon’s goal date • Source: Alamy

More from Biosimilars

More from Products