The product would target the lucrative, billion-dollar worldwide market for Xolair.
Celltrion Healthcare will initiate a phase 3 trial of its omalizumab biosimilar (CT-P39) candidate for the treatment of chronic idiopathic urticaria, a form of hives, based on a regulatory green light from the Republic of Korea’s Ministry of Food and Drug Safety.
CT-P39 references the Genentech and Novartis product Xolair, an injectable prescription drug that targets and blocks immunoglobulin E. It is approved in the United States, the European Union, and Japan for the treatment of adults and children with moderate-to-severe asthma and chronic hives. The drug had worldwide sales of $1.17 billion in 2019, a 13% increase from the year before.
According to Republic of Korea press reports, the CT-P39 trial would be conducted at 65 sites in 7 countries, with a target enrollment of 600 patients with chronic idiopathic urticaria. The end points are efficacy and safety demonstrated via comparison of CT-P39 and Xolair. Trial completion is anticipated by the 2023 half-year point.
A phase 1 pharmacokinetic trial was initiated for CT-P39 in 2019.