
A phase-1 randomized aimed to establish the pharmacokinetic (PK) and pharmacodynamic (PD) equivalence of proposed biosimilar Insulin N (Biocon's Insulin‐N) and US‐licensed Humulin® N (Humulin‐N; Eli Lilly and Company, IN) in healthy subjects. Biocon's Insulin‐N was equivalent to Humulin‐N for the primary PK and PD endpoints. The safety profile of Biocon's Insulin‐N was also similar to that of Humulin‐N, and no serious adverse events were reported. The PK and PD equivalence were demonstrated between Biocon's Insulin‐N and Humulin‐N in healthy subjects, and both treatments were well tolerated and considered safe.
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