Carl Lokko
Alvotech (NASDAQ:ALVO) said a confirmatory study for its biosimilar candidate AVT03 met its primary endpoint of demonstrating clinical similarity to Amgen’s (AMGN) osteoporosis drug Prolia.
The Icelandic company said the study demonstrated similarity of AVT03 to Prolia, also known as denosumab, in terms of efficacy, safety, immunogenicity and pharmacokinetics in post-menopausal women with osteoporosis.
Alvotech plans to use the results to support indications for AVT03 as a biosimlar for another Amgen denosumab drug, Xgeva, which is used to prevent fractures in patients with cancers involving bone.
The company said that two additional studies comparing AVT03 to Prolia and Xgeva also met their primary endpoints.
Alvotech intends to file for approval of AVT03 in major markets later this year, the company added.