Posted by Michael Wonder on 25 May 2025
Xbrane Biopharma updates on US FDA biologics license application for its investigational biosimilar candidate to Lucentis (ranibizumab)
23 May 2025 - Xbrane re-submitted the biologics license application) for its investigational biosimilar candidate to Lucentis (ranibizumab) to the US FDA in December 2024.
After submission of additional documentation from the manufacturing sites, the official review cycle was initiated. FDA has now communicated 21 October 2025 as the BsUFA date (decision date).
