- 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
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