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Celltrion Submits aBLA for CT-P39, Proposed Interchangeable Biosimilar of Xolair® (omalizumab)

by Monica Chou; Robert S. Schwartz, Ph.D.
March 31, 2024

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.

We continue to monitor this aBLA and will provide updates once available.  For more information on pending aBLAs, please visit BiologicsHQ.com.

 

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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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