Shots:
- GlycoNex has reported the P-III trial results assessing SPD8 (SC, Q6M), a biosimilar version of denosumab co-developed with Mitsubishi Gas Chemical, vs Prolia in 266 Japanese subjects with osteoporosis
- Trial met its 1EP, with SPD8 demonstrating therapeutic equivalence to Prolia. The between-group difference in the 1EP & its 95% confidence interval fell within the pre-specified equivalence margins established before unblinding
- The company has completed the comparative quality & development package for both osteoporosis and bone metastasis & plans to submit MAAs to Japan’s PMDA in Q3’26 following completion of the clinical study report in Sep 2026. A Taiwan MA filing is planned for 2027, with a targeted launch by year-end 2027
Ref: PRnewswire | Image: GlycoNex | Press Release
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