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Celltrion and Amgen Reach Settlement in Prolia® / Xgeva® Biosimilar Litigation

by Robert S. Schwartz, Ph.D.
January 28, 2025

On January 24, 2025, Amgen announced it had reached a settlement with Celltrion in Case No. 1:24-cv-06497 (D.N.J.) related to Celltrion’s proposed biosimilar of Prolia® / Xgeva® (denosumab), CT-P41.  The lawsuit involved allegations of infringement of 29 of Amgen’s patents (previously reported Amgen Files BPCIA Lawsuit Against Celltrion’s Proposed Prolia® / Xgeva® (Denosumab) Biosimilar CT-P41).  According to the press release, the Court issued an order holding the claims of Amgen’s U.S. patents asserted against Celltrion valid, enforceable, and infringed by CT-P41.  Additionally, the parties reached a confidential settlement that allows Celltrion to launch its biosimilar products in the U.S. as early as June 1, 2025, if approved by the FDA.  Celltrion submitted its aBLA for CT-P41 to the FDA, with a request for interchangeability, in November 2023.

This is the second settlement related to Prolia® / Xgeva® biosimilars.  In April 2024, Amgen and Sandoz settled their dispute (Case No. 1:23-cv-02406 (D.N.J.)) related to Sandoz’s interchangeable biosimilars Jubbonti® / Wyost® (denosumab-bddz), agreeing to a U.S. market entry date of May 31, 2025, or earlier under certain undisclosed circumstances (previously reported Amgen and Sandoz Settle Prolia® / Xgeva® Biosimilar Litigation).

Numerous lawsuits for Prolia® / Xgeva® biosimilars remain pending, including for Samsung Bioepis’s SB16 (Case No. 1:24-cv-08417 (D.N.J.)), Fresenius Kabi’s FKS518 (Case No. 1:24-cv-09555 (N.D. Ill.)), and Accord / Intas’s INTP23 (Case No. 5:24-cv-00642 (E.D.N.C.)).  A pending request for transfer to a Multidistrict Litigation (MDL #3138 in D.N.J.) was filed in November 2024, with a panel hearing set for January 30, 2025.

Amgen reported 2023 U.S. sales for Prolia® of $2.73 billion, and $1.52 billion for Xgeva®.

For more information about these and other biosimilar patent disputes, 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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