Posted by Michael Wonder on 23 Apr 2024
Xbrane provides regulatory update on FDA review of its ranibizumab biosimilar candidate
21 April 2024 - Xbrane Biopharma announce that the US FDA has issued a complete response letter to the Company’s biologics license application for its ranibizumab biosimilar candidate (development name Xlucane) for treatment of retinal disorders.
Xbrane will work closely with the agency to submit as quickly as possible responses to the issues raised, which relate primarily to the reference standard and pre-approval inspections of manufacturing partners’ sites.
