On November 10, 2026, the PTAB Director instituted Amneal and Kashiv’s IPR2026-00260 against Genentech’s U.S. Patent No. 12,030,959 (“the ’959 patent”) in a bulk order without an opinion.  The Petition challenged method of treatment claims related to Genentech’s Xolair^® (omalizumab) as anticipated and obvious (previously reported Amneal and Kashiv File First Xolair^® (omalizumab) IPR). Amneal and Kashiv’s aBLA for proposed biosimilar ADL-018 (omalizumab) was submitted to the FDA in September 2025 (previously reported Amneal / Kashiv Submit an aBLA for Xolair^® (omalizumab) Proposed Biosimilar ADL-018).

The ’959 patent was asserted by Genentech against ADL-018 in ongoing BPCIA Litigation No. 1:26-cv-01343 (D. Del.) filed in October 2026 (previously reported Genentech Files First BPCIA Litigation Against Proposed Xolair^® Biosimilar ADL-018).

In October 2026, Celltrion launched the first Xolair^® interchangeable biosimilar, Omlyclo^® (omalizumab-igec) at a 15% discount (previously reported Biosimilar U.S. Launches: Omlyclo^® the First Interchangeable Biosimilar of Xolair^® and Filkri™ a Neupogen^® Biosimilar).  Teva has a pending aBLA for TEV-45779 (omalizumab) that was accepted by the FDA in March 2026 (previously reported FDA and EMA Accept Teva’s Omalizumab Biosimilar Applications).

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.