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…
