FDA Shoots Down Avastin Biosimilar Over Manufacturing Issues

The US Food and Drug Administration (FDA) has denied Biocon and Viatris’ application for their biosimilar to Avastin, a monoclonal antibody therapy for multiple cancer types. The agency cited issues  related to cleaning procedures and anti-contamination protocols it noted during facility inspections in Bengalaru, India, and Johor, Malaysia, last August. The company intends to address the issues and provide the agency with a Corrective and Preventative Action (CAPA) plan.

According to Katherine Lewin, “In Bengaluru, procedures to prevent microbial contamination of products were not being followed, and the facility couldn’t prevent contamination of products or equipment by environmental conditions. The FDA also noted that when there were deviations from written procedures and “laboratory mechanisms,” those deviations weren’t recorded. Also, the oversight of GMP manufacturing and laboratory operations was “inadequate.””

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(Source: Endpoints News, February 13^th, 2023)