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Prolia® / Xgeva® Biosimilar Updates: FDA Approves Accord’s Osvyrti® / Jubereq®, Amgen and Hikma Settle BPCIA Litigation

by Leah Watson; Robert S. Schwartz, Ph.D.
November 26, 2025

On November 20, 2025, the FDA approved Accord’s Osvyrti® and Jubereq® (denosumab-desu), biosimilars of Amgen’s Prolia® / Xgeva® (denosumab).

This is the eighth Prolia® / Xgeva® biosimilar approval, and follows Gedeon Richter / Hikma’s Enoby™ / Xtrenbo™ (denosumab-qbde), approved on September 26, 2025 (previously reported FDA Approves Prolia® / Xgeva® (denosumab) Biosimilars: Henlius’s Bildyos® / Bilprevda®, Biocon’s Bosaya™ / Aukelso™, and Gedeon Richter’s Enoby™ / Xtrenbo™).  Various other aBLAs for denosumab biosimilars remain pending at the FDA, including Teva’s TVB-009P (accepted in October 2024), Amneal’s MB09 (accepted in March 2025), and Alvotech / Dr. Reddy’s AVT03 (accepted in March 2025).

On November 24th, Hikma and Gedeon Richter reached a confidential settlement agreement with Amgen in Case No. 1:25-cv-12152 (D.N.J.).  The parties agreed to an injunction preventing the commercial launch of Gedeon Richter / Hikma’s Enoby™ / Xtrenbo™ until January 1, 2026.

BPCIA litigations remain ongoing for numerous Prolia® / Xgeva® biosimilars, including for Shanghai Henlius Biotech’s Bildyos™ / Bilprevda™ (denosumab-nxxp) (Case No. 1:25-cv-12160 (D.N.J.)) (previously reported Amgen Files Three New Prolia® / Xgeva® BPCIA Litigations Against Hikma, Shanghai Henlius Biotech, and Biocon’s Proposed Biosimilars), Alvotech / Dr. Reddy’s AVT03 (Case No. 1:25-cv-17277 (D.N.J.)),  Amneal / mAbxience’s MB09 (Case No. 1:25-cv-17278 (D.N.J.)), and  Alkem’s ENZ215 (Case No. 1:25-cv-17596 (D.N.J.)) (previously reported Amgen Files Three New Prolia® / Xgeva® BPCIA Litigations Against Proposed Biosimilars AVT03, MB09, and ENZ215).

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

For more information on this and other biologic patent disputes, please visit BiologicsHQ.com.

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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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