Shots:
- The CHMP has granted a positive opinion to Obodence (60mg pre-filled syringe) & Xbryk (120mg vial), biosimilar versions of Prolia & Xgeva (denosumab), respectively
- Opinion 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
- P-III study depicting SB16’s similar efficacy, safety, immunogenicity & PK/PD vs reference in postmenopausal osteoporosis (PMO) patients (n=457). The 1EPs of % change in lumbar spine BMD at mos.12 was met, with sustained comparability up to mos.18, incl. after switching from denosumab to SB16
Ref: Samsung Bioepis| Image: Samsung Bioepis| Press Release
Related News:- Alvotech and Advanz Pharma Reports the EMA’s MAA Acceptance of AVT05 (Biosimilar, Simponi)
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