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Amgen and Accord Settle Prolia® / Xgeva® BPCIA Litigation over INTP23

by Robert S. Schwartz, Ph.D.
July 29, 2025

On July 16, 2025, Amgen and Accord settled Case No. 1:25-cv-01305 (D.N.J.) / MDL 1:25-md-03138 (D.N.J.) alleging infringement of 34 of Amgen’s patents by Accord’s proposed Prolia® / Xgeva® (denosumab) biosimilar INTP23 (previously reported BPCIA Lawsuit Against Accord’s Proposed Prolia® / Xgeva® Biosimilar Filed by Amgen).  In the consent judgment, Accord agreed that all the asserted patents are valid, enforceable, and infringed by INTP23.  The parties agreed to enter an injunction against the commercial launch of INTP23 until October 1, 2025, if FDA-approved.  The settlement allows market entry prior to the latest expiring asserted patent.

This is the fourth denosumab BPCIA litigation that has been settled (previously reported Amgen and Sandoz Settle Prolia® / Xgeva® Biosimilar Litigation; Celltrion and Amgen Reach Settlement in Prolia® / Xgeva® Biosimilar Litigation; Biosimilar Cases to Watch: Prolia/Xgeva and Denosumab Competitors with The Center for Biosimilars; Prolia® / Xgeva® (denosumab) Biosimilar Updates: Celltrion Biosimilar Approval, Amneal aBLA Filing, and Fresenius Kabi Litigation Settlement).  Four other litigations remain ongoing related to Samsung Bioepis’s Ospomyv™ / Xbryk™ (denosumab-dssb) (Case No. 1:24-cv-08417 (D.N.J.) / MDL 1:25-md-03138 (D.N.J.)), Hikma’s RGB-14 (Case No. 1:25-cv-12152 (D.N.J.)), Shanghai Henlius Biotech’s HLX14 (Case No. 1:25-cv-12160 (D.N.J.)), and Biocon’s Bmab 1000 (Case No. 1:25-cv-13358 (D.N.J.) / MDL 1:25-md-03138 (D.N.J.)).

Since June 2025, three denosumab biosimilars have launched in the U.S., including Sandoz’s interchangeable biosimilars Jubbonti® / Wyost® (denosumab-bbdz) (previously reported Sandoz Launches Jubbonti® / Wyost® (denosumab-bbdz) as First Prolia® / Xgeva® Interchangeable Biosimilars), Fresenius Kabi’s Conexxence™ / Bomyntra™ (denosumab-bnht), and Celltrion’s Stoboclo® / Osenvelt® (denosumab-bmwo) (previously reported Fresenius Kabi and Celltrion Launch Prolia® / Xgeva® (denosumab) Biosimilars Conexxence™ / Bomyntra™ and Stoboclo® / Osenvelt®).

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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