Shots:
- The EC has approved SB16: Ospomyv (denosumab-dssb; 60mg pre-filled syringe) & Xbryk (denosumab-dssb; 120mg vial), a biosimilar version of Prolia & Xgeva for osteoporosis & prevention of skeletal related events, respectively
- Approval was based on the P-I trial which confirmed PK equivalence between SB16, EU-DEN & US-DEN among healthy males, in terms of AUC from time zero to infinity & maximum serum concentration (1EPs)
- Additionally, P-III trial depicted SB16’s similar efficacy, safety, immunogenicity & PK/PD vs reference in postmenopausal osteoporosis (PMO) pts. The 1EPs of % change in lumbar spine BMD was met at 12mos., with sustained comparability up to 18mos., incl. after switching from denosumab to SB16
Ref: Samsung Bioepis | Image: Samsung Bioepis
Related News:- Samsung Bioepis Reports the EC’s approval of Obodence & Xbryk (Biosimilar, Denosumab)
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