Insights into PK ‐Based Bridging for Products Using a Common Autoinjector Platform: A Review of 16 Autoinjectors in 14 Biological License Applications
Abstract
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.
Fields of Study & Subjects
Monoclonal and Polyclonal Antibodies Research
Protein purification and stability
Viral Infectious Diseases and Gene Expression in Insects
Publication details
- Journal / source
- Clinical Pharmacology & Therapeutics
- Publisher
- Wiley
- Volume
- 120
- Issue
- 1
- Pages
- 28–31
- Publication date
- 14 April 2026
- Language
- EN