Biocon updates on CRL from USFDA for Biologics License Application

"The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) for Bevacizumab filed by our partner Viatris (Mylan). The CRL informs the need for a satisfactory resolution of the observations made during the facility inspection conducted in August, 2022. We have submitted a comprehensive Corrective and Preventive Action (CAPA) plan, to the agency and are confident of addressing the observations within the stipulated timeframe. The CRL did not identify any outstanding scientific issues with the dossier."- Company Spokesperson, Biocon Biologics.

Shares of Biocon Limited was last trading in BSE at Rs. 242.45 as compared to the previous close of Rs. 243.15. The total number of shares traded during the day was 1317948 in over 3521 trades.

The stock hit an intraday high of Rs. 244.50 and intraday low of 239.70. The net turnover during the day was Rs. 318106790.00.

Source : Equity Bulls

Keywords

BioconBiologics INE376G01013 CRL USFDA BiologicsLicenseApplication Bevacizumab Viatris