Alvotech initiates a pharmacokinetic study for AVT03

A proposed biosimilar for Prolia® and Xgeva®

Prolia® and Xgeva® (denosumab) are indicated for the treatment of bone disease, with combined sales of nearlyUS$5.3 billionin 2021

Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today the initiation of a pharmacokinetic study for AVT03 (denosumab), a biosimilar candidate to Prolia® and Xgeva®. The clinical study will assess the pharmacokinetics, safety and tolerability of AVT03 compared to Prolia® in healthy adult male subjects.

Prolia® (denosumab) is indicated for the treatment of osteoporosis in postmenopausal women and for bone loss in adult men and women at increased risk of fracture. Xgeva® (denosumab), which is the same biologic in a different presentation, is indicated for prevention of skeletal-related events such as pathological fractures in adults with advanced malignancies involving bone. It is also indicated for the treatment of giant cell tumor in bone. In 2021, combined net revenues worldwide from sales of Prolia® and Xgeva® were nearly US$5.3 billion.

Rapid progress in the development of our product portfolio exemplifies the capabilities of Alvotech’s biosimilars platform. This milestone in the AVT03 program is a further step in our important mission to improve lives by expanding access to affordable biologic medicines.

Joseph McClellan, Chief Scientific Officer

For more information visit Alvotech's website.