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