Xbrane Reveals Ranibizumab Refiling Plans For US
FDA Said Additional Information Was Needed To Accept Lucentis Rival BLA For Review
Xbrane has set out its plans to resubmit its application for a biosimilar rival to Lucentis in the US, after receiving details from the FDA on additional information needed for the agency to accept the BLA for review.
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With Samsung Bioepis already holding US and EU approvals for biosimilar ranibizumab, Swedish sponsor Xbrane Biopharma says 12-month Phase III data supports ongoing registration of the Lucentis rival in both regions.