Blog Big Molecule Watch July 07, 2022

Update on Xbrane’s Ranibizumab Application

In May 2022, Xbrane announced that it had withdrawn its biologics license application (BLA) for its ranibizumab biosimilar of LUCENTIS®.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.

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