Shots:
- The EC has approved SB16: Obodence (60mg pre-filled syringe; Biosimilar: Prolia) & Xbryk (120mg vial; Biosimilar: 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 (n=168), 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 (n=457). The 1EPs of % change in lumbar spine BMD at mos.12 was met, with sustained comparability up to 18mos., incl. after switching from denosumab to SB16
Ref: Samsung Bioepis | Image: Samsung Bioepis
Related News:- Samsung Bioepis and Teva Partners to Commercialize Epysqli (Biosimilar, Soliris) in the US
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