In May 2022, Xbrane announced that it had withdrawn its biologics license application (BLA) for its ranibizumab biosimilar of LUCENTIS®. On July 4, 2022, Xbrane announced that based on comments and recommendations in a General Advice letter received from FDA, “Xbrane plans to resubmit the [ranibizumab] BLA during 2022,” and that “[p]rovided that all comments and recommendations from the preliminary review are satisfactorily addressed in the application, the BLA will be filed and a full review initiated latest 60 days post re-submission.”
Stay tuned to Big Molecule Watch for further updates on Xbrane’s ranibizumab application.