Biocon, India's biggest biopharma, revealed that the U.S. FDA has rejected its BLA for bevacizumab, a proposed biosimilar to Roche's Avastin.
In a brief company statement in the form of a letter to the Bombay Stock Exchange, the company acknowledged that it had received a Complete Response Letter (CRL) for the application filed by partner Viatris. According to Biocon, the FDA requires a resolution of the observations made during the facility inspection conducted in August 2022.
The FDA had previously issued three Form 483s following inspections of the manufacturing facilities of Biocon's Biologics arm. The agency conducted three on-site inspections of the company's facilities, spanning two sites in Bengaluru, India and one in Johor, Malaysia. According to the drugmaker, the observations primarily related to the need for improving strategies for microbial control, enhancing quality oversight, augmenting the use of software applications and computerized tools to aid risk assessment and investigations and other procedural and facility upgrades.
Biocon's proposed biosimilar to Novo Nordisk’s NovoLog was the first casualty of the inspections. The FDA rejected the drug last month, citing the need for additional data in the BLA submission and implementation of a CAPA plan pertaining to the August inspection of the Bangalore facilities.
Now, bevacizumab seems to have suffered a similar fate. Biocon says it submitted a comprehensive CAPA plan to the agency and are "confident of addressing the observations within the stipulated timeframe. The CRL did not identify any outstanding scientific issues with the dossier.”