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Amgen Files Three New Prolia® / Xgeva® BPCIA Litigations Against Proposed Biosimilars AVT03, MB09, and ENZ215

by Leah Watson; Robert S. Schwartz, Ph.D.
November 19, 2025

On November 6, 2025, Amgen filed its eighth and ninth BPCIA lawsuits against proposed biosimilars of Prolia® / Xgeva® (denosumab), Case No. 1:25-cv-17277 (D.N.J.) against Alvotech and Dr. Reddy’s AVT03 and Case No. 1:25-cv-17278 (D.N.J.) against Amneal, Genhelix, Universal Farma, and mAbxience’s MB09.

On November 14, 2025, Amgen filed its tenth BPCIA lawsuit, Case No. 1-25-cv-17596 (D.N.J.) against Alkem Laboratories, Ascend Laboratories, and Enzene Biosciences’s proposed biosimilar ENZ215.  The aBLA for ENZ215 was accepted by the FDA on an undisclosed date.

Both the case against Dr. Reddy’s / Alvotech and the case against Amneal / mAbxience assert infringement of 31 U.S. patents. The number of each patent claim type asserted is the same in both cases: 29 manufacturing, four composition of matter, two composition, and one host cell. The case against Alkem asserts 35 patents: 31 manufacturing, four composition of matter, three host cell, and two composition.  One patent has not been previously asserted; U.S. Patent No. 9,320,816, asserted against Amneal. The remaining patents have been asserted in prior litigations.

Five 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; Amgen and Samsung Bioepis Reach Settlement in Prolia® / Xgeva® Biosimilar Litigation; Amgen and Biocon Reach Settlement in Prolia® / Xgeva® Biosimilar Litigation).

Most recently, in October 2025, the FDA approved Gedeon Richter / Hikma’s Enoby™ / Xtrenbo™ (denosumab-qbde) as the seventh Prolia® / Xgeva® biosimilars (previously reported FDA Approves Prolia® / Xgeva® (denosumab) Biosimilars: Henlius’s Bildyos® / Bilprevda®, Biocon’s Bosaya™ / Aukelso™, and Gedeon Richter’s Enoby™ / Xtrenbo™).

The other cases against Gedeon Richter / Hikma (Case No. 1:25-cv-12152 (D.N.J.)), Henlius / Organon (Case No. 1:25-cv-12160 (D.N.J.)) and Accord / Intas (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 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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