Pharmacokinetic and pharmacodynamic bioequivalence of Gan & Lee insulin analogues aspart, lispro and glargine with EU‐ und US‐sourced reference insulins

The study successfully demonstrated the bioequivalence of insulin biosimilars to their European Union and United States reference products. This achievement is critical to gaining approval and clinical prescription for these insulin biosimilars. The study included three different GL insulins, and the results showed that their pharmacokinetic and pharmacodynamic profiles closely matched those of the reference products. The primary endpoints' mean ratios were nearly 100%, with confidence intervals well within the accepted range of 80% to 125%. Importantly, no significant safety differences or serious adverse events were observed. This development holds promise for improving access to insulin treatments.