On 24 December 2024, GlycoNex announced that it has entered into a licensing agreement with an undisclosed partner for SPD8 (denosumab), biosimilar to Amgen’s Prolia® and Xgeva®. Under the agreement, the licensee will be responsible for developing SPD8, securing regulatory approval, and commercialising the biosimilar in an undisclosed market.
SPD8 entered Phase 3 clinical trials in December 2024.
Sandoz’s Wyost® and Jubbonti® were the first denosumab biosimilars approved in the US in March 2024. No other denosumab biosimilars have been approved in the US to date, although Gedeon Richter/Hikma (December 2024), Organon/Shanghai Henlius (October 2024), Teva (October 2024), and Fresenius Kabi (May 2024) have each had Biologics Licence Applications accepted for review by the FDA. Celltrion filed an aBLA for its biosimilar denosumab in December 2023.
Sandoz’s Wyost® and Jubbonti® are also the only denosumab biosimilars currently approved in Europe (May 2024). However, the European Medicines Agency has accepted MAAs for a number of denosumab biosimilars including for STADA/Alvotech (AVT03, October 2024), Teva (TVB-009P, October 2024), Gedeon Richter (July 2024), Fresenius Kabi (FKS518, July 2024), and Shanghai Henlius/Organon (HLX14, May 2024). The CHMP has adopted positive opinions for Samsung Bioepis’ Obodence™ and Xbryk™ (SB16) (November 2024) and Celltrion’s Osenvelt®/CT-P41 and Stoboclo®/CT-P41 (December 2024).