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.
Li et al. (Tue,) studied this question.