XBRANE submits BLA for ranibizumab biosimilar candidate to FDA
Other Corporate Information
Xbrane Biopharma AB (publ) ("Xbrane" or "the Company") (Nasdaq Stockholm: XBRANE) has submitted the BLA (Biologics License Application) for its investigational biosimilar candidate to LUCENTIS® (ranibizumab) to FDA (US Food and Drug Administration)
Xbrane has submitted the BLA for its investigational biosimilar candidate to LUCENTIS® (ranibizumab) to the FDA. Within 60 days, FDA is expected to validate and decide to initiate the review of the BLA. Thereafter, Xbrane expects a 10 month review process and hence an approval could take place during the first half of 2024.
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 Age-related Macular Degeneration (AMD), retinal vein occlusion (RVO) or myopic choroidal neovascularization (mCNV).
LUCENTIS® is a registered trademark of Genentech Inc.