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News

Amneal / Kashiv Submit an aBLA for Xolair® (omalizumab) Proposed Biosimilar ADL-018

by Leah Watson; Robert S. Schwartz, Ph.D.
September 28, 2025

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®.

We continue to monitor this aBLA.  For more information on pending aBLAs and biosimilar patent disputes, please visit BiologicsHQ.

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The authors 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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