Xbrane Biopharma has withdrawn the BLA (Biologics License Application) for its investigational biosimilar candidate to Lucentis after receiving feedback from the FDA that complementary information is required for the FDA to take the decision to accept the BLA and initiate the review.
Xbrane will receive more information about the requested complementary information from the FDA in a few weeks, after which a firm timeline for re-submission of the BLA will be communicated. Provided that all requested information is satisfactory added, the BLA would be accepted for initiation of review latest 60 days post re-submission.
Xbrane remains committed to advance its investigational biosimilar candidate towards approval in the United States as quickly as possible to provide a much needed, cost-efficient treatment alternative for patients suffering from severe eye diseases, it states.
Lucentis is a registered trademark of Genentech Inc.
Photo of Martin Åmark, CEO, Xbrane