Alvotech begins confirmatory trial of Amgen Prolia/Xgeva biosimilar
gorodenkoff

Alvotech (NASDAQ:ALVO) said it began a confirmatory patient study for AVT03, a biosimilar of Amgen's (NASDAQ:AMGN) bone disorder drugs Prolia and Xgeva.
The Iceland-based company said the aim of the trial is to show similarity of AVT03 to Prolia in terms of efficacy, safety, immunogenicity, and pharmacokinetics in postmenopausal women with osteoporosis.
The results from this study will be used to support additional indications for AVT03 (denosumab) to XGeva based on extrapolation, the company said in an Aug. 25 press release.
In AVT03-GL-C01 study, ~476 people, postmenopausal women 50 years or older diagnosed with osteoporosis, will receive either three doses of AVT03 or Prolia at six-month intervals.
Prolia (denosumab) â which generated sales of ~$3.25B in 2021 â is approved to treat osteoporosis in women after menopause and for certain men and women; for bone loss in adult men and women at increased risk of fracture. Meanwhile, Xgeva (denosumab) â which brought in sales of ~$2.02B in 2021 â is used to prevent fracture, spinal cord compression or the need for radiation or surgery to bone in patients with multiple myeloma and in patients with bone metastases from solid tumors.
Alvotech (ALVO) noted that it has now entered four biosimilar candidates into confirmatory patient studies.