Biocon partner Viatris gets Complete Response Letter from USFDA for Bevacizumab license application

Bevacizumab is a medication used to treat a number of types of cancers and a specific eye disease.

Published On 2023-02-13 05:43 GMT   |   Update On 2023-02-13 05:48 GMT
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BangaloreBiotechnology firm Biocon has announced that 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.

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"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.

Read also: Inclusive and growth-oriented budget: Biocon Chief Kiran Mazumdar-Shaw

Biocon Limited is an innovation-led global biopharmaceuticals company headquartered in Bangalore. It has developed and commercialized novel biologics, biosimilars, and complex small molecule APIs in India and several key global markets, as well as generic formulations in the US and Europe.

Read also: Biocon CSR arm wins 'IHW Gold Award for Diseases Screening Initiative of the Year' for 2022

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