Positive top line results frpm PK study of AVT 03 a denosumab biosimilar
Alvotech announced positive top-line results from a pharmacokinetic (PK) study for AVT 03, a biosimilar candidate to Prolia and Xgeva, which both contain denosumab.
The PK study (AVT03-GL-P01), which assessed the pharmacokinetics, safety, and tolerability of AVT 03 compared to Prolia in healthy adult subjects, met its primary endpoints. A confirmatory efficacy study for AVT 03 in patients is currently underway, as well as a PK study comparing AVT03 to Xgeva in healthy adult subjects.
Prolia (denosumab) is indicated for the treatment of osteoporosis in postmenopausal women and for bone loss in adult men and women at increased risk of fracture. Xgeva, which is also denosumab but in a different presentation, is indicated for prevention of skeletal-related events such as pathological fractures in adults with advanced malignancies involving bone. It is also indicated for the treatment of giant cell tumor in bone. In the last twelve months before September 30, 2023, reported combined net revenues worldwide from sales of Prolia and Xgeva were over US$6 billion, based on the manufacturer’s reported quarterly sales.
The patents on Prolia/Xgeva will expire in the US on 19 February 2025 and expired in Europe on 25 June 2022, except for France, Italy, Spain and the UK, where they will expire in 2025
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