Kashiv Biosciences says it is looking forward to initiating dosing in the company’s global Phase III clinical study “soon” for its ADL018 proposed biosimilar to Genentech/Novartis’s Xolair (omalizumab) in chronic spontaneous urticaria patients, after the candidate completed a successful global Phase I clinical study in healthy volunteers.
“For all comparisons of primary endpoints (AUCinf and Cmax), the 90% confidence intervals of the geometric least squares means ratio were fully contained within the pre-defined equivalence margin of 0.80-1.25
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