After seeing its ranibizumab biologics license application knocked back by the US Food and Drug Administration earlier this year, Xbrane Biopharma has set out plans to resubmit the filing for a biosimilar rival to Lucentis by the end of 2022, with additional data and information that will allow US agency to accept the BLA for review.
The Swedish biosimilars developer revealed in May that it had “withdrawn the BLA for its investigational biosimilar candidate to Lucentis after receiving feedback from the FDA that complementary information is required