AryoGen Pharmed Reports P-III Trial Results of Denosumab Biosimilar Demonstrates Noninferiority to Prolia for Postmenopausal Osteoporosis
Shots:
- The P-III trial evaluates Arylia vs Prolia in 190 postmenopausal women aged 45 & 75yrs. with osteoporosis across 12 centers in Iran. At 0, 6 & 12mos., patients were given a 60mg, SC of the biosimilar or original drug & then monitored until 18mos.
- The results showed a similar efficacy & safety of Arylia along with noninferiority to reference Prolia, the percent changes in BMD at lumbar spine/total hip/femoral neck in the biosimilar group were 5.91/2.32/1.91 over 5.52/2.28/1.50 in the reference Prolia
- Reduction in the bone formation markers BSAP, OC, and P1NP & no new vertebral fractures were observed, reduction in bone resorption markers serum CTX and serum NTX over 18mos., AEs were reported in 78% vs 64%
Ref: AJMC | Image: AryoGen Pharmed
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