Celltrion USA completes submission of Biologics License Application (BLA) to U.S. FDA for CT-P39, an interchangeable biosimilar candidate of XOLAIR® (omalizumab)

The BLA for CT-P39 was based on totality of evidence including results from Phase III data demonstrating comparable efficacy and safety profile with the reference product XOLAIR® (omalizumab) in patients with chronic spontaneous urticaria JERSEY CITY, N.J., March 10, 2024 /PRNewswire/ –…