Biocon Receives Complete Response Letter from US FDA for Biosimilar Bevacizumab

Biocon Limited has received a Complete Response Letter (CRL) from the US Food and Drug Administration (US FDA) for its Biologics License Application (BLA) for bBevacizumab, a biosimilar to Avastin. The CRL did not identify any outstanding scientific issues on the dossier, but the FDA has requested a pre-approval inspection of the bBevacizumab manufacturing facility. The company remains engaged with the FDA and is committed to bringing its high-quality, affordable biosimilar bevacizumab to market in the United States.,