Shares of Biocon declined nearly 2% after its lower opening at ₹261.20 against its previous close at ₹264.55 after the USFDA issues complete response letter for proposed biosimilar Insulin Aspart.
Biocon, a leading player in the field of biotechnology, announced on Saturday that the US health regulatory authority has issued a comprehensive response letter regarding Biocon Biologics’ application for Insulin Aspart, a proposed biosimilar for diabetes management. This letter from the US Food and Drug Administration (USFDA) signifies that their initial evaluation of the application has concluded, and they are unable to grant approval in its current state.
Complete Response Letter (CRL) from the USFDA can potentially lead to a decline in the company’s share price. This response indicates that the initial application did not meet the regulatory standards for approval.
At 9:30 AM the shares of Biocon were trading 1.23% down or ₹3.10 or at ₹261.45.
