Alvotech Announces Topline Results From Confirmatory Patient Study For AVT03, A Proposed Biosimilar For Prolia and Xgeva

Author: Benzinga Newsdesk | July 02, 2024 09:13am

Positive topline results demonstrate clinical similarity between AVT03 and the reference biologic, Prolia® (denosumab)
Two additional studies comparing the pharmacokinetics, safety, and tolerability of AVT03 to Prolia and Xgeva, respectively, have also met their primary endpoint
Alvotech expects to file marketing applications for AVT03 later this year for major global markets

REYKJAVIK, Iceland, July 02, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ:ALVO), a global biotech company specialized in the development and manufacture of biosimilar medicines for patients worldwide, announced today positive topline results from a confirmatory patient study for AVT03, a proposed biosimilar to Prolia® (denosumab) and Xgeva® (denosumab). The study met its primary endpoints. The objective of the study is to demonstrate clinical similarity of AVT03 to Prolia in terms of efficacy, safety, immunogenicity, and pharmacokinetics (PK) in postmenopausal women with osteoporosis. The results will be used to support additional indications for AVT03 as a proposed biosimilar to Xgeva, based on extrapolation.

Posted In: ALVO