Celltrion Confirms Bioequivalence for CT-P39 Against Xolair in Interim Results of Phase 3 Study

On April 10, 2023, Celltrion confirmed the bioequivalence of CT-P39 to treat allergic asthma and chronic urticaria, through its interim results from its global phase 3 clinical trials at 24 weeks.  CT-P39 is a biosimilar referencing Xolair (ingredient: omalizumab), which is an antibody biopharmaceutical that treats allergic asthma, chronic urticaria, and chronic rhinosinusitis.  Xolair’s substance patent has already expired and the formulation patent is set to expire in March 2024 in Europe and November 2025 in the U.S.  Celltrion said that it “plans to complete the remaining phase 3 studies of CT-P39 and file for product license in Korea and key other countries later this year.”