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FDA Approves Prolia® / Xgeva® (denosumab) Biosimilars: Henlius’s Bildyos® / Bilprevda®, Biocon’s Bosaya™ / Aukelso™, and Gedeon Richter’s Enoby™ / Xtrenbo™

by Leah Watson; Robert S. Schwartz, Ph.D.
October 1, 2025

On October 1, 2025, the FDA approved Gedeon Richter / Hikma’s Enoby™ / Xtrenbo™ (denosumab-qbde), biosimilars of Amgen’s Prolia® / Xgeva® (denosumab).

This is the seventh Prolia® / Xgeva® biosimilar approval, and follows Biocon’s Bosaya™ / Aukelso™ (denosumab-kyqq), approved on September 16, 2025 and Organon / Shanghai Henlius Biotech’s (“Henlius”) Bildyos® / Bilprevda® (denosumab-nxxp), approved on August 29, 2025.  Various other aBLAs for denosumab biosimilars remain pending at the FDA, including Teva’s TVB-009P (accepted in October 2024), Accord / Intas’s INTP23 (undisclosed filing date prior to November 2024, Amneal’s Denosumab Amneal (accepted in March 2025), and Alvotech / Dr. Reddy’s AVT03 (accepted in March 2025).

Biocon is involved in a BPCIA litigation related to Bosaya™ / Aukelso™, Case No. 1:25-cv-13358 (D.N.J.) / MDL 1:25-md-03138 (D.N.J.), and Henlius / Organon are litigating Bildyos® / Bilprevda® in BPCIA Case No. 1:25-cv-12160 (D.N.J.).

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

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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