US FDA again delays Biocon bevacizumab approval on back of 483s

The Complete Response Letter (CRL) outlines the need for Biocon Biologics to resolve observations made during facility inspections in August 2022.

Biocon confirmed the US Food and Drug Administration (FDA) has issued a CRL for the Biologics License Application (BLA) for a biosimilar version of Roche’s Avastin (bevacizumab) filed by Viatris (formerly known as Mylan). Biocon   acquired the biosimilars division from its partner Viatris in February 2022 in a deal worth $3.3 billion.

“The US FDA has issued a CRL for the 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,” Biocon said in a statement.

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According to Biocon, the majority of the observations were related to improving strategies for microbial control, improving quality oversight, enhancing the use of various software applications, as well as computerized tools to support risk assessment, investigations, and various facility upgrades.

In response to the CRL, Biocon said it has submitted a comprehensive Corrective and Preventive Action (CAPA) to the FDA and it is “confident of addressing the observations within the stipulated timeframe. The CRL did not identify any outstanding scientific issues with the dossier.”

Viatris’ bevacizumab is approved in numerous regions, including Europe and Canada, under the name Abevmy to treat certain types of cancer. However, in December 2020, COVID-19 travel restrictions stopped the US FDA inspecting Biocon’s plants and thus this CRL is the latest roadblock to the firm’s bisoimilar reaching the US market.