FDA Issues CRL for Biocon/Viatris Bevacizumab Biosimilar

On Feb 12, 2023, Biocon Biologics announced that the FDA issued a Complete Response Letter (CRL) for its Biologics License Application (BLA) for its biosimilar referencing AVASTIN (bevacizumab), previously submitted by Viatris.  Biocon Biologics completed the multi-billion dollar acquisition of Viatris’s global biosimilar business in December 2022.  The CRL relates to observations made during a facility inspection conducted in August 2022.  According to Biocon, the company has “submitted a comprehensive Corrective and Preventive Action (CAPA) plan,” and “are confident of addressing the observations within the stipulated timeframe.”  Biocon also states that the “CRL did not identify any outstanding scientific issues with the dossier.”