Denosumab Clinical Trial Updates

The Big Molecule Watch is monitoring Phase III clinical trials involving denosumab biosimilars.  Here we report on the results of two recently completed studies.

On June 30, 2022, a study was published showing that the efficacy of AryoGen Pharmed’s biosimilar denosumab candidate, ARYLIA, is noninferior to Amgen’s PROLIA for the treatment of osteoporosis in postmenopausal osteoporotic Iranian women.  Osteoporosis is a common bone metabolic disease leading to compromised bone strength and augmented risk of fractures affecting more than 200 million people worldwide.  The primary endpoint of the Phase III study was noninferiority with respect to the percentage change of bone mineral density after 18 months in the lumbar spine, total hip, and femoral neck.  The study also found the two products comparable in terms of safety.

On July 27, 2022, the results of another Phase III study conducted by Qilu Pharmaceuticals on its denosumab biosimilar, QL1206, for the treatment of osteoporosis in postmenopausal Chinese women was published.  The study found that after 12 months the patients receiving QL1206 exhibited significantly increased bone mineral density in the lumbar spine, total hip, femoral neck, and trochanter compared to patients receiving placebo.  The study further found that no new or unexpected adverse events were observed.