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Amgen Files Three New Prolia® / Xgeva® BPCIA Litigations Against Hikma, Shanghai Henlius Biotech, and Biocon’s Proposed Biosimilars

by Robert S. Schwartz, Ph.D.
July 3, 2025

On June 25, 2025, Amgen filed its sixth and seventh BPCIA lawsuits against proposed biosimilars of Prolia® / Xgeva® (denosumab), Case No. 1:25-cv-12152 (D.N.J.) against Hikma and Gedeon Richter’s RGB-14 and Case No. 1:25-cv-12160 (D.N.J.) against Shanghai Henlius Biotech and Organon’s HLX14.  On June 30, 2025, Amgen filed an additional BPCIA lawsuit against Biocon Biologics’ Bmab 1000, Case No. 1:25-cv-11867 (D. Mass.).  The Complaint against Biocon was the first public announcement that Biocon has filed an aBLA for a Prolia® / Xgeva® biosimilar.

The case against Hikma alleges infringement of 32 patents, including 30 patents that claim methods of manufacturing, four patents claiming compositions of matter, two patents claiming compositions, and one patent claiming host cells.  The case against Henlius alleges infringement of many of the same patents and includes 24 patents that claim methods of manufacturing, two patents claiming compositions of matter, one patent claiming compositions, and one patent claiming host cells.  The case against Biocon alleges infringement of 34 patents, including 30 patents that claim methods of manufacturing, four patents claiming compositions of matter, three patents claiming host cells, and two patents claiming compositions.  A total of 51 patents have now been asserted against Prolia® / Xgeva® biosimilars.  The most recent cases added four previously unasserted patents: U.S. Patent Nos. 8,217,153; 9,371,554; 11,192,919; and 11,492,372, all of which claim manufacturing methods.

Three of the previously filed cases have settled (previously reported Amgen and Sandoz Settle Prolia® / Xgeva® Biosimilar Litigation; Celltrion and Amgen Reach Settlement in Prolia® / Xgeva® Biosimilar Litigation; Prolia® / Xgeva® (denosumab) Biosimilar Updates: Celltrion Biosimilar Approval, Amneal aBLA Filing, and Fresenius Kabi Litigation Settlement), and most recently, earlier in June 2025, Sandoz launched the first interchangeable biosimilars Jubbonti® / Wyost® (denosumab-bbdz) (previously reported Sandoz Launches Jubbonti® / Wyost® (denosumab-bbdz) as First Prolia® / Xgeva® Interchangeable Biosimilars).  The other cases against Samsung Bioepis’s Ospomyv™ / Xbryk™ (denosumab-dssb) (Case No. 1:24-cv-08417 (D.N.J.) / MDL 1:25-md-03138 (D.N.J.)) and Accord / Intas’s INTP23 (Case No. 1:25-cv-01305 (D.N.J.) / MDL 1:25-md-03138 (D.N.J.)) remain ongoing.

Amgen reported FY24 U.S. sales for Prolia® of $2.885 billion, and $1.507 billion for Xgeva®.

For an overview of Prolia® / Xgeva® patent proceedings and aBLAs, please visit Spotlight On: Prolia® / Xgeva® (denosumab) / Jubbonti® / Wyost® (denosumab-bbdz) / Ospomyv™ / Xbryk™ (denosumab-dssb) / Stoboclo® / Osenvelt® (denosumab-bmwo) / Conexxence™ / Bomyntra™ (denosumab-bnht).  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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