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Celltrion Completes Application for FDA Approval of CT-P41, Biosimilar of Prolia® / Xgeva®

by Monica Chou; Robert S. Schwartz
December 19, 2023

On November 30, 2023, Celltrion announced that it filed for an abbreviated Biologics License Application (aBLA) for FDA approval of CT-P41 (denosumab), a proposed biosimilar of Amgen’s Prolia® / Xgeva® (denosumab).  There is currently another pending aBLA for a proposed biosimilar of Prolia® / Xgeva® from Sandoz for GP2411, which was accepted by the FDA in February 2023.  A litigation involving GP2411 was filed in May 2023 and is currently pending.  Amgen, Inc. et al v. Sandoz, Inc. et al, No. 1:23-cv-02406 (D.N.J.).  No patent disputes related to Celltrion’s CT-P41 have been filed yet.

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

    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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