Sławomir Jeka, Eva Dokoupilová, Alan Kivitz, Paweł Żuchowski, Barbara Vogg, Natalia Krivtsova, Susmit Sekhar, Samik Banerjee, Arnd Schwebig, Johann Poetzl, Jean-Jacques Body, Richard Eastell
Denosumab is a monoclonal antibody used to reduce risk of fractures in osteoporosis. ROSALIA was a multicenter, double-blind, randomized, integrated phase I/phase III study comparing the efficacy, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and safety of proposed biosimilar denosumab GP2411 with reference denosumab (REF-DMAb) (Prolia®; Amgen). Postmenopausal women with osteoporosis were randomized 1:1 to two 60 mg doses of GP2411 or REF-DMAb, one at study start and one at Week 26...
January 29, 2024: Journal of Bone and Mineral Research