Samsung Bioepis Reports the US FDA’s approval of Ospomyv & Xbryk (Biosimilar, Prolia & Xgeva)
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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A passionate content writer with expertise in delivering high-quality and engaging content, Dipanshu is a keen reader and a versatile writer. Dipanshu dedicatedly covers news ranging from biopharma, life sciences, biotech, and MedTech to diagnostics and animal health companies, FDA, EMA, and biosimilar approvals. He can be contacted at connect@pharmashots.com
