Organon announced FDA acceptance of its aBLA for HLX14, a biosimilar of Amgen’s Prolia®/Xgeva® (denosumab), licensed from Shanghai Henlius Biotech. Teva also announced FDA and EMA acceptance of its Prolia® biosimilar TVB-009P. These join Celltrion, Fresenius Kabi, and Samsung Bioepis’s denosumab biosimilar applications awaiting FDA approval. Litigations between Amgen and Celltrion, Samsung Bioepis, and Fresenius Kabi are ongoing. Sandoz’s Jubbonti®/Wyost® (denosumab-bddz) was FDA-approved as interchangeable with Prolia®/Xgeva®, with a U.S. market entry date by May 31, 2025, or earlier under certain circumstances.