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.
