Xbrane Biopharma
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Xbrane Biopharma AB (publ) ("Xbrane" or "the Company") (Nasdaq Stockholm: XBRANE) has re-submitted the BLA (Biologics License Application) for its investigational biosimilar candidate to LUCENTIS® (ranibizumab) to FDA (US Food and Drug Administration).
Xbrane submitted the BLA for its investigational biosimilar candidate to LUCENTIS® (ranibizumab) to the FDA in April 2023 and subsequently received a Complete Response Letter (CRL) in April 2024. In the CRL FDA requested additional information related to the reference standard and follow-up actions from the pre-approval inspections of manufacturing partners’ sites. Xbrane has since, after alignment with FDA, qualified a new reference standard and worked together with its manufacturing partners to complete the requested follow-up actions. The review cycle of a re-submitted BLA is typically 6 months.
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 | 2024-12-31, kl 09:00 |
| Källa | MFN |