Posted by Michael Wonder on 20 Oct 2025
Xbrane provides regulatory update on FDA review of its ranibizumab biosimilar candidate
19 October 2025 - 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 for treatment of retinal disorders.
The complete response letter refers to observations following a re-inspection of one of Xbrane’s contract manufacturers.
