The Korea Herald reported that Celltrion has confirmed in its phase III clinical trial that its omalizumab biosimilar CT-P39 is bioequivalent to Genentech/Novartis’ Xolair®. The company presented the final results of its 40 week clinical trial during the American College of Allergy, Asthma and Immunology (ACAAI) 2023 conference in California.
Celltrion is also reported to have submitted its application for approval of CT-P39 in Korea in June 2023 (as well as in Europe in April 2023).
Celltrion reported its 24 week results from the study in April 2023, the same month it reported that it submitted its application to the EMA.