Shots:

• The P-I study assesses the PK/PD- safety- tolerability of SB16 (denosumab) vs Prolia in 168 healthy male volunteers for osteoporosis. The study will be 3 arms study that involves dosing with SB16 either the EU or US-sourced Prolia
• The proposed biosimilar references Amgen’s Prolia which was approved in 2010 for osteoporosis with a high risk of fracture
• With the initiation- Samsung Bioepis continues to advance its biosimilar portfolio covering immunology- oncology- ophthalmology- and hematology

 ­ Ref: Business Wire | Image: Samsung Bioepis