Insights into <scp>PK</scp> ‐Based Bridging for Products Using a Common Autoinjector Platform: A Review of 16 Autoinjectors in 14 Biological License Applications

An emerging proposal suggests that prior findings of pharmacokinetic comparability for one product could be applied to other therapeutic protein products that use the same autoinjector platform. We investigated 16 autoinjectors using one platform and found that (a) pharmacokinetic comparability outcomes varied and (b) these outcomes were not attributable to identified device performance parameters or product viscosity. Further investigations are necessary to support the proposed extrapolation across products sharing the same autoinjector platform.