On February 28, 2025, the FDA approved Celltrion’s Stoboclo® / Osenvelt® (denosumab-bmwo) as the third company to receive FDA approval of biosimilars of Amgen’s Prolia® / Xgeva® (denosumab). The other two companies are Sandoz’s Jubbonti® / Wyost® (denosumab-bbdz), approved as interchangeable biosimilars in March 2024, and Samsung Bioepis’s Ospomyv™ / Xbryk™ (denosumab-dssb), approved as interchangeable biosimilars on February 13, 2025.
On March 3, 2025, Amneal and mAbxience announced the FDA accepted for review its aBLA for two denosumab biosimilars of Prolia® / Xgeva®. Other pending denosumab aBLAs include Fresenius Kabi (FKS518), Teva (TVB-009P), Organon / Shanghai Henlius Biotech (HLX14), Accord / Intas (INTP23), and Gedeon Richter / Hikma (RGB-14).
On March 7, 2025, Amgen and Fresenius Kabi dismissed their BPCIA litigation, Case No. 1:25-cv-01080 (D.N.J.) / MDL 1:25-md-03138 (D.N.J.), which was recently transferred from the Northern District of Illinois and consolidated into a Multidistrict Litigation (see Biosimilar Cases to Watch: Prolia/Xgeva and Denosumab Competitors). The settlement came only five months after the case was filed and followed a recent settlement with Celltrion (previously reported Celltrion and Amgen Reach Settlement in Prolia® / Xgeva® Biosimilar Litigation). The details of the settlement have not yet been disclosed.
For an overview of the FDA and patent dispute activity for denosumab biosimilars, a new Spotlight On dashboard is now available at Spotlight On: Prolia® / Xgeva® (denosumab) / Jubbonti® / Wyost® (denosumab-bbdz) / Ospomyv™ / Xbryk™ (denosumab-dssb) / Stoboclo® / Osenvelt® (denosumab-bmwo).
Amgen reported FY24 U.S. sales for Prolia® of $2.885 billion, and $1.507 billion for Xgeva®.
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The author would like to thank April Breyer Menon for her contributions to this article.
