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^®.

For more information about these and other biosimilars and biosimilar patent disputes, please visit BiologicsHQ.

 

_____________________________________________________

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