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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 nearly US$5.3 billion in 2021 AVT03 (denosumab) is the
About this update from Alvotech
[{"type":"text","content":"Prolia® and Xgeva® (denosumab) are indicated for the treatment of bone disease, with combined sales of nearly US$5.3 billion in 2021 AVT03 (denosumab) is the 4th product in Alvotech’s portfolio to enter clinical studies REYKJAVIK, ICELAND (July 20, 2022) – 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 billion1. “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,” said Joseph McClellan, Chief Scientific Officer. Alvotech’s current portfolio of eight products and product candidates target treating autoimmune disease, eye disorders, osteoporosis, respiratory disease, and cancer. Of these, four products have either been launched or entered clinical studies. Alvotech has launched its first marketed product AVT02 (adalimumab), a biosimilar to Humira®, in Europe and Canada. In May, Alvotech announced positive topline results from both a confirmatory clinical, safety and efficacy study and from a pharmacokinetic (PK) study for AVT04 (ustekinumab), a proposed biosimilar to Stelara®. In July, Alvotech announced the initiation of a confirmatory clinical study for AVT06 (aflibercept), a proposed biosimilar to Eylea®. 1Based on manufacturer’s reported sales About Alvotech Alvotech specializes in making biosimilars, to improve lives by e...