On September 26, 2025, Amneal / Kashiv announced the submission to the FDA of an aBLA for ADL-018, a proposed biosimilar of Genentech’s Xolair® (omalizumab). This is the only currently pending publicly announced aBLA for a Xolair® biosimilar, and follows Celltrion’s Omlyclo® (omalizumab-igec), which is the first interchangeable biosimilar of Xolair®, approved by the FDA as interchangeable in March 2025 (previously reported FDA Approves First Interchangeable Biosimilar of Xolair®: Celltrion’s Omlyclo® (omalizumab-igec)).
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 U.S. sales of $1.643B for Xolair®.
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The authors would like to thank April Breyer Menon for her contributions to this article.
