On March 10, 2024, Celltrion announced in a press release that it submitted an abbreviated Biologics License Application (aBLA) for FDA approval of CT-P39 (omalizumab), a proposed interchangeable biosimilar of Genentech’s / Novartis’ Xolair® (omalizumab). This is the first publicly announced aBLA for a proposed biosimilar of Xolair®. No patent proceedings related to any proposed Xolair® biosimilar have been filed to date.
Xolair® generated worldwide sales of $3.85B in 2023.
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The authors would like to thank April Breyer Menon for her contributions to this article.
