Celltrion seeks approval for Xolair biosimilar from Health Canada

[Photo by Yonhap]

South Korea’s Celltrion on Wednesday announced its submission for approval of CT-P39, a biosimilar version of Xolair (omalizumab) used for conditions like asthma and hives, to Canada’s Health Canada.

Xolair, a monoclonal antibody biopharmaceutical developed by Genentech and Novartis, is used in allergic asthma, chronic rhinosinusitis with nasal polyps, and chronic idiopathic urticaria.

Celltrion said that it completed the application for approval encompassing all indications for which Xolair is used based on the results from a multinational Phase 3 clinical trial conducted across six European countries. Earlier this year, the company concluded applications for CT-P39 in Europe and South Korea, with plans underway for sequential submissions in countries like the United States.

“The U.S. and Europe are expanding their favorable policies towards biosimilars. We aim to expand our product portfolio to cover various conditions, providing high-quality biosimilar medicines and enhancing patients’ access to treatment,” said a Celltrion spokesperson.