The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) for Insulin Aspart filed by our partner Viatris (Mylan).

The CRL did not identify any outstanding scientific issues with the product. The CRL references the Form 483 observations noted during the pre-approval inspection of Biocon Biologics' integrated insulins manufacturing facility at Malaysia in August 2022, which we disclosed on Aug 31, 2022.

"We have submitted a CAPA (Corrective and Preventive Action) plan to the U.S. FDA for review and remain confident in our ability to resolve these observations expeditiously.

"Biocon Biologics remains committed to the global standards of Quality and Compliance," said a company spokesperson.