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…
