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Alvotech Reports Positive Top-line Results from Study on AVT03, Biosimilar to Amgen Inc’s Prolia® and Xgeva® (denosumab)

Jan 29, 2024

Alvotech announced positive top-line results for AVT03, its biosimilar to Amgen Inc’s Prolia® and Xgeva® (denosumab).  The study (AVT03-GL-P01) was a randomised, double-blind, parallel-group study evaluating the pharmacokinetics, safety, and tolerability of AVT03 compared to Prolia® in healthy adult male subjects 28to 55 years old.  The results of the study have not yet been published.

On 7 September 2022, Lupin and partner DKSH announced an exclusive licensing and supply agreement to market Alvotech’s AVT03 and four other Alvotech biosimilar products (golimumab, aflibercept and two undisclosed biosimilars for immunology and oncology) in the Philippines.