Xbrane Biopharma has assembled a task force of “very experienced team members,” both from the firm and also with “external expertise,” after the Swedish pure play developer received a US Food and Drug Administration complete response letter denying approval for its proposed Xlucane (ranibizumab) biosimilar to Lucentis.
The setback comes nine months after Xbrane refiled its Xlucane biologics license application to the agency – that following a May 2022 withdrawal of the application after the FDA told the firm that