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xbrane

Xbrane Biopharma Reports Resubmission of BLA to the US FDA for Ranibizumab Biosimilar Candidate 

Shots:  Xbrane Biopharma has resubmitted the BLA for its biosimilar product, referencing Genentech’s Lucentis (ranibizumab), to the US FDA post issuance of CRL in Apr 2024  The CRL stated requirement for additional information on the reference standard and follow-up actions from manufacturing site inspections. Xbrane has addressed the issues, qualifying new reference standard & completing…

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