On 10 June 2026, GlycoNex announced that its denosumab biosimilar, SPD8, met the primary endpoint in a Phase 3 osteoporosis study conducted in Japan, demonstrating therapeutic equivalence to Amgen’s Prolia® (denosumab). SPD8 was co-developed by GlycoNex with Mitsubishi Gas Chemical.
GlycoNex and Mitsubishi Gas Chemical plan to complete the clinical study report by the end of September 2026 and file marketing approval applications in Japan in Q3 2026, referencing both Amgen’s Prolia® and Xgeva®. A regulatory filing in Taiwan is planned for 2027, with a target launch date by end-2027.
There is one approved denosumab biosimilar in Japan, Alvotech’s AVT03 (DENOSUMAB BS 120 mg/1.4 mL in a vial for subcutaneous injection; September 2025), biosimilar to Daiichi Sankyo’s Ranmark® (marketed in other countries as Amgen’s Xgeva®).
Denosumab biosimilars have been approved and launched around the world by a variety of sponsors. In the US, this includes Sandoz’s Jubbonti® and Wyost® (approved March 2024, launched June 2025), Samsung Bioepis’ Ospomyv™ and Xbryk™ (approved February 2025, Ospomyv™ included on US formularies from 1 April 2026), Celltrion’s Stoboclo® and Osenvelt® (approved March 2025, launched July 2025), Fresenius Kabi’s Conexxence® and Bomyntra® (approved March 2025, launched July 2025), Shanghai Henlius/Organon’s Bildyos® and Bilprevda® (approved September 2025, launched October 2025), Richter/Hikma’s Enoby™ and Xtrenbo™ (approved September 2025; launched January 2026), Accord’s Osvyrti® and Jubereq® (approved November 2025) and Amneal/mAbxience’s Boncresa™ and Oziltus™ (MB09) (approved December 2025).