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News

FDA Approves First Interchangeable Biosimilar of Xolair®: Celltrion’s Omlyclo® (omalizumab-igec)

by Robert S. Schwartz, Ph.D.
March 13, 2025

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®.

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

 

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

 

    Methodology

    Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.

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