Biocon Biologics and its Partner Viatris Receive the Complete Response Letter from the US FDA for Bevacizumab Biosimilar
Shots:
- The US FDA has issued a CRL for biosimilar referencing Avastin (bevacizumab) previously submitted by Viatris & also requested additional data to be submitted
- The US FDA did not identify any issues with the preclinical and clinical trial results that were submitted in the dossier as part of the BLA for the bevacizumab product. Additionally, Biocon has submitted a comprehensive Corrective and Preventive Action (CAPA) plan to the US FDA
- Bevacizumab biosimilar is currently available in Canada where it is marketed under the name Abevmy. If it is approved in the US, it will be 5th bevacizumab biosimilar to receive the US FDA approval
Ref: Biocon Biologics | Image: Biocon Biologics
Related Post:- Biocon and Mylan Report the US FDA Acceptance of BLA for Proposed Biosimilar of Avastin (bevacizumab)
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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
