On October 16, 2026, Genentech filed BPCIA Litigation No. 1:26-cv-01343 (D. Del.) against Kashiv and Amneal alleging infringement of nine patents by their proposed Xolair^® (omalizumab) biosimilar ADL-018.  This is the first litigation filed against a Xolair^® biosimilar.  Seven of the asserted patents claim manufacturing methods and processes and two patents claim methods of treatment.  Six of the patents have not been previously asserted in a biosimilar litigation.  One patent, U.S. Patent No. 12,030,959, has been challenged by Kashiv and Amneal in IPR2026-00260, which is awaiting an institution decision (previously reported Amneal and Kashiv File First Xolair^® (omalizumab) IPR).

According to the Complaint, the parties agreed to litigate the asserted patents, but it did not disclose any further details about the patent dance exchanges.

Amneal and Kashiv submitted their aBLA for ADL-018 in September 2025 (previously reported Amneal / Kashiv Submit an aBLA for Xolair^® (omalizumab) Proposed Biosimilar ADL-018).  There is one other publicly disclosed aBLA for a Xolair^® biosimilar, Teva’s TEV-45779, accepted by the FDA in March 2026 (previously reported FDA and EMA Accept Teva’s Omalizumab Biosimilar Applications).  Celltrion launched its interchangeable biosimilar Omlyclo^® (omalizumab-igec) earlier in October at a 15% discount (previously reported Biosimilar U.S. Launches: Omlyclo^® the First Interchangeable Biosimilar of Xolair^® and Filkri™ a Neupogen® Biosimilar).

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