Presented at the 2016 ACR/ARHP Annual Meeting, November 13, 2016, Washington, DC
Discussion/Conclusions
•M923 was shown to be bioequivalent on all of the primary endpoints:
Ratio of M923 to EU Humira was 99.39 (90% CI 94.25-104.81) and to US Humira was 102.58 (90% CI 97.31 to 108.14). – AUC0-inf ratios of M923 to EU Humira was 100.90 (90% CI 93.48-108.90) and to US Humira was 104.20 (90% CI 96.47-112.54)
Safety • The incidence, severity, and type of AEs were similar across study arms. • There were no deaths and no AEs leading to early withdrawal