XBRANE PROVIDES AN UPDATE ON RANIBIZUMAB BIOSIMILAR CANDIDATE FDA FILING
Other Corporate Information
Xbrane Biopharma AB (publ) ("Xbrane" or "the Company") (Nasdaq Stockholm: XBRANE) updates the timing for re-submission of the BLA (Biologics License Application) for its investigational biosimilar candidate to LUCENTIS® to first quarter of 2023.
Xbrane withdrew the BLA (Biologics License Application) at the end of May for its investigational biosimilar candidate to LUCENTIS® after receiving feedback from the FDA (U.S. Food and Drug Administration), following a preliminary review, that additional information was required for the FDA to take the decision to accept the BLA and initiate a full review. Xbrane received comments and recommendations from the FDA in June and has since worked intensively together with suppliers, contract manufacturers and partners to address. The delivery of a critical report required for the re-submission has been delayed and therefore the re-submission of the BLA has been postponed to first quarter of 2023.
Xbrane will next update on the BLA upon successful validation by the FDA, which is expected 60 days post re-submission.
Xbrane is fully 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.
LUCENTIS® is a registered trademark of Genentech Inc.