Blog Big Molecule Watch August 26, 2022

Alvotech Initiates Confirmatory Patient Study for AVT03, a Proposed Denosumab Biosimilar

Alvotech announced this week the initiation of a confirmatory patient study for AVT03 (denosumab), a biosimilar candidate to PROLIA® and XGEVA®, to demonstrate clinical similarity to PROLIA® in terms of efficacy, safety, immunogenicity, and pharmacokinetics in postmenopausal women with osteoporosis.  According to Alvotech, the results from this trial will be used to support additional indications for AVT03 to XGEVA® based on extrapolation.  PROLIA® (denosumab) is indicated for the treatment of osteoporosis in postmenopausal women and for bone loss in adults at increased risk of fracture.  XGEVA® (denosumab) is indicated for prevention of skeletal-related events.

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