On March 30, 2026, Teva announced that the FDA and the European Medicines Agency (EMA) accepted regulatory submissions for its proposed biosimilar to Xolair^® (omalizumab), TEV-45779.

The submissions include a Biologics License Application (BLA) to the FDA and a Marketing Authorization Application (MAA) to the EMA. The applications seek approval for all indications of the reference product, including moderate-to-severe persistent allergic asthma in patients aged six years and older, chronic rhinosinusitis with nasal polyps in adults, IgE-mediated food allergy in adult and pediatric patients aged 1 year and older, and chronic idiopathic urticaria in adults and adolescents 12 years of age and older.

To date, one omalizumab biosimilar has been approved by the FDA, Celltrion’s Omlyclo^® (omalizumab-igec), which received approval in March 2025 and was designated as interchangeable (previously reported FDA Approves First Interchangeable Biosimilar of Xolair^®: Celltrion’s Omlyclo^® (omalizumab-igec)). One additional aBLA for an omalizumab biosimilar, Amneal / Kashiv’s ADL-018, remains pending following FDA acceptance in September 2025 (previously reported Amneal / Kashiv Submit an aBLA for Xolair^® (omalizumab) Proposed Biosimilar ADL-018).

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 2025 global sales of $1.723B for Xolair^®.

For more information about these and other biosimilars, please visit BiologicsHQ.

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The authors would like to thank April Breyer Menon for her contributions to this article.