Prolia is currently prescribed for osteoporosis in postmenopausal women and bone loss in adults at increased risk of fractures. Credit: Dragana Gordic / Shutterstock.

Alvotech has reported positive topline data from a confirmatory patient study, AVT03-GL-C01, assessing AVT03 as a proposed biosimilar to denosumab drugs Prolia and Xgeva.

The randomised, multi-centre, double-blind, parallel-design study assessed the efficacy, immunogenicity, safety, and pharmacokinetic profiles of AVT03 versus Prolia in postmenopausal women with osteoporosis.

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It enrolled nearly 532 participants aged 50 years or above. They were randomly assigned to receive three doses of either AVT03 or Prolia at six-month intervals, with a re-randomisation for the third dose in the Prolia arm.

The primary outcome measures included changes from baseline in bone mass density (BMD) and a biomarker for bone resorption.

The study’s objective was to demonstrate the clinical similarity of AVT03 to Prolia in terms of efficacy, safety, immunogenicity, and pharmacokinetics.

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According to the latest findings, the study met its primary endpoints.

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In addition to the AVT03-GL-C01 study, Alvotech conducted two other studies, AVT03-GL-P01 and AVT03-GL-P03, which compared the pharmacokinetics, safety, and tolerability of AVT03 to Prolia and Xgeva, respectively.

Both studies, involving over 200 healthy adult participants each, also met their primary endpoints.

The successful results from these studies are intended to support the use of AVT03 for additional indications as a proposed biosimilar to Xgeva.

Prolia is currently prescribed for osteoporosis in postmenopausal women and bone loss in adults at increased risk of fractures.

Xgeva is used to prevent skeletal-related events in adults with advanced malignancies involving bone and to treat giant cell tumours of the bone.

Alvotech chief scientific officer Joseph McClellan said: “We are pleased with these results, demonstrating clinical similarity between AVT03 and the reference biologic. In addition, we have now obtained positive topline results from two PK studies that show equivalent PK, safety, and tolerability of AVT03 compared to Prolia and Xgeva, respectively.

“These clinical milestones underline the capabilities of our dedicated biosimilar platform and continued diversification of our portfolio. We expect to file marketing applications for AVT03 for major global markets later this year.”