Shots:
- GlycoNex, in partnership with Mitsubishi Gas Chemical Company, has concluded the P-I trial assessing SPD8, biosimilar version of Prolia (denosumab), for treating osteoporosis. Both the companies have completed the P-I study across Japan
- Based on these results, SPD8 will proceed to P-III trial aimed at assessing its efficacy, safety & immunogenicity among larger patient population with osteoporosis, for which the company is in discussion with regulatory authorities. Trial is planned in Q4’24
- The P-I trial in healthy postmenopausal women reached its 1EPs, depicting similar PK/PD & safety b/w SPD8 vs denosumab
Ref: Prnewswire| Image: GlycoNex| Press Release
Related News:- Lupin Reports the P-III Study Completion of LUBT010 (Biosimilar, Lucentis) for Neovascular Age-related Macular Degeneration
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