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 partner Viatris (Mylan).
"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," - Biocon Biologics spokesperson said.Biocon is an innovation-led, global biopharmaceutical company committed to enhancing affordable access to complex therapies for chronic conditions like diabetes, cancer and autoimmune diseases.
The company had reported a net profit (before exceptional items) of Rs 168 crore in Q2 FY23, down by 10% from Rs 188 crore in Q2 FY22. Revenue from operations increased by 26% YoY to Rs 2,320 crore during the quarter.
The Biocon scrip fell 0.29% to settle trade at Rs 242.45 on Friday, 10 February 2023.
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