After seeing its ranibizumab biologics license application knocked back by the US Food and Drug Administration earlier this year, Xbrane Biopharma has set out plans to resubmit the filing for a biosimilar rival to Lucentis by the end of 2022, with additional data and information that will allow US agency to accept the BLA for review.
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.
