Xbrane Biopharma
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Stockholm/Bad Vilbel/New York – In April 2024 Xbrane Biopharma AB (“Xbrane”) received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its Biologics License Application (BLA) for its ranibizumab biosimilar candidate (development name Xlucane™) for treatment of retinal disorders.
FDA requested additional information primarily related to the reference standard and follow-up actions from the pre-approval inspections of manufacturing partners’ sites.
Xbrane has since communicated with FDA, and is working together with its partners, including US license holder Valorum Biologics, on addressing the respective requests. Xbrane has the ambition to re-submit the BLA in the fourth quarter of 2024. Should this submission be successful, this would result in a BsUFA date during the second quarter of 2025 assuming a standard 6 month review process and ongoing alignment with the FDA, as well as successful execution of remediation plans of the manufacturing partners.
| Datum | 2024-07-08, kl 13:00 |
| Källa | MFN |