Efficacy and Safety of the Biosimilar Denosumab Candidate (Arylia) Compared to the Reference Product (Prolia®) in Postmenopausal Osteoporosis

A Phase III, Randomized, Two-Armed, Double-Blind, Parallel, Active-Controlled, and Noninferiority Clinical Trial

Ahmadreza Jamshidi; Mahdi Vojdanian; Mohsen Soroush; Mahmoud Akbarian; Mehrdad Aghaei; Asghar Hajiabbasi; Zahra Mirfeizi; Alireza Khabbazi; Gholamhosein Alishiri; Anousheh Haghighi; Ahmad Salimzadeh; Hadi Karimzadeh; Fatemeh Shirani; Mohammad Reza Hatef Fard; MohammadAli Nazarinia; Soosan Soroosh; Nassim Anjidani; Farhad Gharibdoost


Arthritis Res Ther. 2022;24(161) 

In This Article


This study demonstrated the noninferiority of the biosimilar denosumab (Arylia) to the reference product in osteoporotic postmenopausal women. In general, there was no difference in the lumbar spine, total hip, or femoral neck BMD percentage change, the trend of bone metabolism biomarkers, or the occurrence of new vertebral fractures between the biosimilar denosumab and the reference product.