Posted by Michael Wonder on 11 Mar 2024
Celltrion USA completes submission of biologics license application to US FDA for CT-P39, an interchangeable biosimilar candidate of Xolair (omalizumab)
10 March 2024 - 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.
Celltrion USA today announced that the company has submitted a biologics license application for CT-P39, an interchangeable biosimilar candidate to Xolair (omalizumab) to the US FDA.
