On March 7, 2025, the FDA approved Celltrion’s Omlyclo® (omalizumab-igec), the first interchangeable biosimilar of Genentech’s Xolair® (omalizumab). Omlyclo® was approved for all of Xolair®’s approved indications, including for certain patients with asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), IgE-mediated food allergy, and chronic idiopathic urticaria (CSU).
To date, there are no publicly announced aBLAs for Xolair® biosimilars, but several companies are reportedly developing them, including Teva (TEV-45779 completed Phase 3 trial), Amneal / Kashiv (ADL018 in Phase 3 trial) and Aurobindo / CureTeQ (BP11 successfully completed Phase 1 trial).
There are eight patents related to Xolair® listed in the FDA’s Purple Book, but no current patent disputes related to Xolair® biosimilars.
Novartis reported 2024 sales of $1.643B for Xolair®.
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The author would like to thank April Breyer Menon for her contributions to this article.
