On 19 August 2024, Taiwanese-based GlycoNex announced that SPD8, biosimilar to Amgen’s Prolia® (denosumab), is expected to enter a Phase 3 clinical trial in Q4 2024. The trial will assess the efficacy, safety and immunogenicity of SPD8 in patients with osteoporosis.
This follows the simultaneous announcement of successful completion of GlycoNex’s Phase 1 trial for SPD8 in Japan. SPD8 met the primary endpoint of clinical pharmacokinetic equivalence to Prolia® in healthy postmenopausal women.
SPD8 was developed by GlycoNex with Mitsubishi Gas Chemical Company, Inc. Approval for the phase 1 trial of SPD8 from the Japanese Pharmaceuticals and Medical Devices Agency was announced in May 2023.
Denosumab biosimilars have been approved in the US (Sandoz’s Jubbonti® and Wyost®, March 2024), Canada (Sandoz’s Jubbonti®, February 2024 and Wyost®, March 2024), Europe (Sandoz’s Jubbonti® and Wyost®, May 2024), China (Boan Biotech’s Byoubei® (November 2022) and Boluojia® (May 2024) and Mabwell’s Mailishu® (March 2023) and MaiweijianTM (April 2024)).