Biocon’s Biosimilar Difficulties: Successive FDA Rejections Don’t Inspire Hope
Last week, the Indian biopharmaceutical giant Biocon announced that the FDA had issued them a complete response letter for their bevacizumab biosimilar to Roche/Genentech’s Avastin, following routine pre-approval facility inspections. This rejection comes just a month after a similar rejection for their biosimilar version of insulin aspart.
In a brief letter to the stock exchange, Biocon revealed that they had received a complete response letter from the FDA, which “informs the need for a satisfactory resolution of observations made during the facility inspections conducted in August 2022.” These facility inspections were part of the pre-approval procedure for several biosimilars, including bevacizumab.
Biocon added that they had submitted a comprehensive Corrective and Preventative Action plan to the FDA. They are confident that they will be able to address the observations within the stipulated timeframe, as the complete response letter “did not identify any outstanding scientific issues with the dossier” for the bevacizumab biosimilar.
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The brevity of Biocon’s statement makes it appear as though they want to keep their cards close to their chest with this FDA slap-down. However, this is not the first time the biopharma has made headlines in recent months due to the FDA finding issues in their manufacturing process following facility inspections in both India and Malaysia. In January, Biocon received another complete response letter for their biosimilar version of insulin. The letter cited a need for “additional data and corrective measures” at the firm’s manufacturing facilities in Bengaluru, India.
In the August facility inspections, the FDA found that the procedures to prevent microbial contamination of products were not being followed and that the Bengaluru facility could not control the contamination of products or equipment by environmental conditions. Moreover, the complete response letter cited deviations from written procedures and “laboratory mechanisms”, but these deviations were not recorded anywhere. The FDA added that the oversight of GMP manufacturing and laboratory operations was “inadequate.”
Biocon was partnered on the development of the bevacizumab biosimilar with Viatris. Bevacizumab is used to treat several forms of cancer, and it is the active drug in Roche/Genentech’s Avastin cancer therapy. In February last year, Viatris sold their business to Biocon for $3.3 billion, so at this point, it is not entirely clear whether Viatris is still involved in the FDA application which has just received a rejection.
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