Xbrance provides update on ranibizumab biosimilar candidate FDA filing

Xbrane Biopharma

30 May 2022 - Xbrane Biopharma has withdrawn its biologics license application for its investigational biosimilar candidate to Lucentis after receiving feedback from the U.S. FDA that complementary information is required for the FDA to take the decision to accept the biologics license application and initiate the review.

Xbrane will receive more information about the requested complementary information from the FDA in a few weeks, after which a firm timeline for resubmission of the biologics license application will be communicated.

Read Xbrance Biopharma press release

Michael Wonder

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Michael Wonder

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Medicine , US , Biosimilar , Dossier