"We have submitted a comprehensive Corrective and Preventive Action (CAPA) plan to the agency and are confident of addressing the observations within the stipulated time frame," Biocon said
Biotechnology firm Biocon on Sunday said the US health regulator has issued a Complete Response Letter (CRL) for the biologics licence application filed for Bevacizumab by its partner Viatris. The US Food and Drug Administration (USFDA) issues a CRL to convey to a company that its initial review of an application is complete and it cannot approve the application in its present form.
"The USFDA has issued a CRL for the Biologics License Application (BLA) for Bevacizumab filed by our partner Viatris (Mylan)," a company spokesperson said in a regulatory filing. The CRL informs the need for a satisfactory resolution of the observations made during the facility inspection conducted in August, 2022, it added.
"We have submitted a comprehensive Corrective and Preventive Action (CAPA) plan to the agency and are confident of addressing the observations within the stipulated time frame," Biocon said. Bevacizumab is a medication used to treat a number of types of cancers and a specific eye disease. Earlier on January 7, the company had stated that the USFDA has issued a complete response letter for Biocon Biologics' application for Insulin-R, a proposed biosimilar for diabetes treatment.