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®.
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The authors would like to thank April Breyer Menon for her contributions to this article.
