Samsung Bioepis Initiates P-I Study of SB16 Proposed Biosimilar to Prolia (denosumab)

November 11, 2020 Auto Bot Biosimilars, Clinical Trials, Initiates, Proposed Biosimilar, Samsung Bioepis 0

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

Click here ­to­ read full press release/ article | Ref: Samsung Bioepis | Image: Business Wire

The post Samsung Bioepis Initiates P-I Study of SB16 Proposed Biosimilar to Prolia (denosumab) first appeared on PharmaShots.