United States:
Celltrion Confirms Bioequivalence For CT-P39 Against Xolair In Interim Results Of Phase 3 Study
19 April 2023
Goodwin Procter LLP
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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."
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