Xbrane Resubmits Ranibizumab Biosimilar Application to U.S. FDA
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Last updated: April 30, 2026
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Xbrane Biopharma has resubmitted its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA). This submission is for their novel biosimilar, XBR-052. The resubmission follows earlier feedback from the FDA.
XBR-052 is intended as a biosimilar to the blockbuster drug Stelara, which is used to treat a range of inflammatory conditions such as psoriasis, Crohn's disease, and ulcerative colitis.
The potential market for Stelara and its biosimilars is substantial. Successful approval and market entry of XBR-052 could represent a significant commercial opportunity for Xbrane Biopharma.
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