1. Generics Bulletin
  2. >>Products

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

Biocon Biologics has announced a further complete response letter from the US Food and Drug Administration relating to its biologics license application for a biosimilar version of NovoLog (insulin aspart).

The Indian firm – which recently took over the global biosimilars business of former partner Viatris – said the CRL “did not identify any outstanding scientific issues with the product” but “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

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Generics Bulletin for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Biosimilars

More from Products