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Biosimilar U.S. Launches: Omlyclo® the First Interchangeable Biosimilar of Xolair® and Filkri™ a Neupogen® Biosimilar

by Robert S. Schwartz, Ph.D.
October 14, 2026

On October 5, 2026, Celltrion announced the U.S. launch of Omlyclo® (omalizumab-agec) as the first interchangeable biosimilar of Genentech’s Xolair® (omalizumab), at a 15% discount.  There are no pending patent disputes between Celltrion and Genentech related to Xolair®.  Amneal / Kashiv have a pending aBLA for ADL-018 (accepted in September 2025) and filed IPR2026-00260 challenging U.S. Patent No. 12,030,959, that is awaiting an institution decision (previously reported Amneal / Kashiv Submit an aBLA for Xolair® (omalizumab) Proposed Biosimilar ADL-018; Amneal and Kashiv File First Xolair® (omalizumab) IPR).  Teva also has a pending aBLA for TEV-45770, that was accepted in March 2026 (previously reported FDA and EMA Accept Teva’s Omalizumab Biosimilar Applications).

Novartis reported 2025 global sales of $1.723B for Xolair®.

On October 12, 2026, Accord announced the U.S. launch of Filkri™ (filgrastim-laha), a biosimilar of Amgen’s Neupogen® (filgrastim) that was approved in February 2026 (previously reported FDA Approves Accord’s Neupogen® Biosimilar Filkri™ (filgrastim-laha)).  Filkri™ is the fifth Neupogen® biosimilar to launch in the U.S.  There are no pending patent disputes related to Neupogen® biosimilars.

Sales information for Neupogen® is not separately reported by Amgen.

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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