On 21 April 2024, Swedish biosimilar developer Xbrane announced that the FDA issued a Complete Response Letter (CRL) regarding its BLA for ranibizumab biosimilar XlucaneTM. The issues identified primarily concern (a) the analytical methods for the reference standard; and (b) pre-approval inspections of manufacturing partner’s sites. The FDA has not requested additional clinical studies to demonstrate biosimilarity and has not requested reinspection of any site.
Xbrane will subsequently announce a resubmission date for the ranibizumab BLA.