On 29 October 2025, GlycoNex announced that the last patient has received the final dose in its phase 3 clinical study of SPD8 , biosimilar to Amgen’s Prolia®/Xgeva® (denosumab). The trial, which was commenced in late 2024, is assessing the efficacy, safety and immunogenicity of SPD8 in patients with osteoporosis. GlycoNex plans to report top-line results from the study in the second quarter of 2026.
SPD8 was developed by GlycoNex in collaboration with Mitsubishi Gas Chemical. In December 2024, GlycoNex entered into a licensing agreement with an undisclosed partner for SPD8, under which the licensee will be responsible for developing SPD8, securing regulatory approval, and commercialising the biosimilar in an undisclosed market.
Denosumab biosimilars have been approved around the world, including seven pairs of denosumab biosimilars approved in the US: Sandoz’s Jubbonti® and Wyost® (approved March 2024, launched June 2025), Samsung Bioepis’ Obodence™ and Xbryk™ (approved February 2025, not yet launched), 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, not yet launched), Biocon’s Bosaya™ and Aukelso™ (approved September 2025, launched October 2025) and Richter/Hikma’s Enoby™ and Xtrenbo™ (approved September 2025, not yet launched).