Company Statement on bBevacizumab

Fri, 09 Feb 2024
Posted by: Biocon Biologics
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NOTIFICATION TO STOCK EXCHANGE

COMPANY STATEMENT

Bengaluru, Karnataka, India, February 9, 2024

“The U.S. Food and Drug Administration (U.S. FDA) has issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) for bBevacizumab. The CRL did not identify any outstanding scientific issues on the dossier and informs the need for the completion of a pre-approval inspection of the bBevacizumab manufacturing facility.

“The Company continues to be engaged with the U.S. FDA and looks forward to bringing our high-quality, affordable biosimilar bevacizumab to market in the United States.”

 – Company Spokesperson

 

For more information: seema.ahuja@biocon.com

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Biocon Biologics

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