Alvotech Reports the Initiation of Confirmatory (AVT03-GL-C01) Study for AVT03, a Proposed Biosimilar to Prolia and Xgeva to Treat Osteoporosis


The company initiated a confirmatory (AVT03-GL-C01) study to evaluate AVT03 vs Prolia and Xgeva in ~476 volunteers, postmenopausal women aged ≥50yrs. with osteoporosis. After 18mos. from the initial dose, all patients will have a follow-up visit to conclude the study
The study’s objective is to evaluate the clinical similarity of AVT03 to Prolia in terms of efficacy, safety, immunogenicity, PK & change from baseline in markers for BMD. The results will be used to support additional indications for AVT03 to Xgeva based on extrapolation
Alvotech’s current biosimilars portfolio focuses on autoimmune disease, eye disorders, bone disease, respiratory disease, and cancer

Ref: GlobeNewswire | Image: Alvotech