Biocon and Viatris Draw Complete Response Letter for Bevacizumab BLA

The FDA has issued a complete response letter (CRL) to Biocon and Viatris over their biologics license application (BLA) for bevacizumab, a proposed biosimilar of Roche’s blockbuster cancer drug Avastin.

In the CRL, the FDA expressed concerns over observations by the agency during a 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,” Biocon said. The Indian drugmaker added that the “CRL did not identify any outstanding scientific issues with the dossier.”

Viatris could not be reached for additional comment on the CRL.