Viatris receives CRL from USFDA for Bevacizumab biologics license

13 Feb 2023 , 09:57 AM

Biotechnology company Biocon said on Sunday that its partner Viatris’ Bevacizumab biologics license application has received a Complete Response Letter (CRL) from the US health department.

To inform a company that its initial examination of an application is complete and that it cannot approve the application in its current form, the US Food and Drug Administration (USFDA) issues a CRL.

A firm representative stated in a regulatory filing that the USFDA had issued a CRL for the biologics licence application (BLA) for bevacizumab submitted by our partner Viatris (Mylan).

It was further said that the CRL indicates the requirement for a satisfactory resolution of the findings from the plant inspection carried out in August 2022.

We have provided the agency with a thorough Corrective and Preventive Action (CAPA) plan, and we are certain that we can handle the observations in the allotted period, according to Biocon.

A drug called bevacizumab is used to treat many tumours as well as a particular eye condition.

The USFDA has sent a comprehensive response letter for Biocon Biologics’ application for Insulin-R, a proposed biosimilar for the treatment of diabetes, according to a statement made by the firm earlier on January 7.

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