Xbrane Biopharma AB (publ) ("Xbrane" or "the Company") (Nasdaq Stockholm: XBRANE) updates on US FDA BLA (Biologics License Application) for its investigational biosimilar candidate to LUCENTIS® (ranibizumab)

MAR

Xbrane re-submitted the BLA (Biologics License Application) for its investigational biosimilar candidate to LUCENTIS® (ranibizumab) to the FDA (US Food and Drug Administration) in December 2024. After submission of additional documentation from the manufacturing sites, the official review cycle was initiated. FDA has now communicated October 21st 2025 as the BsUFA date (decision date). An approval would be subject to successful re-inspections of manufacturing sites. Both Manufacturing sites have addressed observations from FDA inspections during 2024 and submitted the relevant documentation to FDA.

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.

Datum 2025-05-23, kl 15:05
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