Sandoz Reports Patient Enrollment in P-I/III ROSALIA Study of Proposed Biosimilar Denosumab for Postmenopausal Osteoporosis

 Sandoz Reports Patient Enrollment in P-I/III ROSALIA Study of Proposed Biosimilar Denosumab for Postmenopausal Osteoporosis

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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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