10:36 AM EDT, 07/02/2024 (MT Newswires) -- Alvotech ( ALVO ) said Tuesday a confirmatory study for AVT03, a proposed biosimilar to Amgen's ( AMGN ) denosumab sold as Prolia and Xgeva, met its primary endpoints.

The study aims to show clinical similarity of AVT03 to Prolia in terms of efficacy, safety, immunogenicity, and pharmacokinetics in postmenopausal women with osteoporosis.

The company said it will use the results to support additional indications for AVT03 as a proposed biosimilar to Xgeva, based on extrapolation.

Alvotech ( ALVO ) expects to file marketing applications for AVT03 for major global markets later in 2024, Chief Scientific Officer Joseph McClellan said.

Prolia is indicated to treat osteoporosis in postmenopausal women and for bone loss in adult men and women at increased risk of fracture, while Xgeva is indicated for prevention of skeletal-related events such as pathological fractures in adults with advanced malignancies involving bone, according to Alvotech ( ALVO ).

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