Alvotech to Launch Pharmacokinetics Study for Denosumab Biosimilar

Editor's Note: This article has been updated to reflect additional information on the development process for the denosumab biosimilar, which was not available at press time Wednesday.

Alvotech announced early Wednesday it will launch a pharmacokinetic (PK) study of AVT03, a proposed biosimilar for 2 different formulations of denosumab, which is used to treat serious bone conditions.

AVT03 is planned as a biosimilar for Prolia, used in the treatment of osteoporosis in postmenopausal women and to treat bone loss in adult men and women who are at increased risk of fracture. It is also planned as a biosimilar for Xgeva, which is indicated to prevent skeletal fractures in patients with cancer. In a statement, Alvotech said the combined revenues for these reference products was $5.3 billion worldwide in 2021.

According to the statement, the study will assess the pharmacokinetics, safety, and tolerability of AVT03 compared with Prolia in healthy adult male subjects. When asked why the PK study would only enroll men, Alvotech officials stated that that the requirements to demonstrate bioequivalence preclude enrollment of young adult women, for both comparative and safety reasons.

Later phases of the development process will study the biosimliar in postmenopausal women, and PK information on this target population will be obtained at that stage.

A 2015 paper discussing denosumab for osteoporosis found that 20% of men and 37% of women in the United States over age 50 are possible candidates for treatment to prevent fractures.

Fourth in pipeline to be studied. AVT03 is the fourth of Alvotech’s 8 products to reach the clinical study phase. The Reyjavik, Iceland-based company has launched AVT02, its adalimumab biosimilar reference to Humira, in Europe and Canada. The company has also announced positive results from 2 studies involving AVT04, which is a ustekinumab biosimilar that references Stelara.

This month, the company announced it had launched a confirmatory clinical study for AVT06, an aflibercept biosimilar referencing Eylea.

“Rapid progress in the development of our product portfolio exemplifies the capabilities of Alvotech’s biosimilars platform,” Joseph McClellan, chief scientific officer, said in a statement. “This milestone in the AVT03 program is a further step in our important mission to improve lives by expanding access to affordable biologic medicines.”