Shots:

• The P-I/III ROSALIA study involves assessing of biosimilar denosumab vs reference product in 520 postmenopausal patients with osteoporosis for 52 wks. following re-randomization of patients receiving the reference therapy to either continue with a third dose or transition to biosimilar denosumab until @78wks.
• The aim of the study is to match bio similarity data with the reference product with 1EPs as a percentage change in lumbar spine bone mineral density and the results are expected to support regulatory submissions
• Denosumab is a mAb targeting RANKL protein which decreases the production and activity of osteoclasts- resulting in a reduction of bone loss- fracture and other bone complications

Click here to read full press release/ article | Ref: Sandoz | Image: Aladeen-Ads