Xbrane Biopharma will be hoping that the third time is the charm for its proposed US biosimilar to Genentech’s Lucentis (ranibizumab). Having already filed a biologics license application for the candidate twice with the US Food and Drug Administration and been knocked back both times, the Swedish biosimilars developer is now making a third attempt to gain approval for the ophthalmic treatment.
An initial US filing for Xbrane’s ranibizumab candidate had been withdrawn back in May 2022 after the firm received “feedback from the FDA that complementary information is required for...