Celltrion Submits BLA for Omalizumab Biosimilar

Last week, Celltrion USA announced it had submitted a BLA for CT-P39, a biosimilar to XOLAIR (omalizumab).  Phase 3 studies demonstrated that in patients with chronic spontaneous urticaria, CT-P39 and reference product XOLAIR (omalizumab) had comparable efficacy and safety.  XOLAIR (omalizumab) is an injectable biologic that is approved in the United States for the treatment of asthma, chronic rhinosinusitis with nasal polyps, IgE-mediated food allergy, and chronic spontaneous urticaria.  According to IQVIA, XOLAIR had global market sales of $3.89 billion in 2022.

Celltrion’s BLA seeks approval to market CT-P39 for all indications for which XOLAIR is approved.   There is currently no FDA-approved biosimilar to XOLAIR (omalizumab), and Celltrion is the first company to seek marketing approval of an omalizumab biosimilar in the United States.