Abstract
A recent paper reviewed clinical studies intending to bridge a prefilled syringe (PFS) to an autoinjector (AI) based on regulatory submission packages sent to the FDA. An AI generally uses the identical PFS within the AI and the AI typically results in a more consistent injection than can be achieved with a PFS. It is noted that several studies submitted to the FDA did not demonstrate bioequivalence (BE) between the PFS and AI, yet the products were approved anyway. The author of this Commentary believes that formal BE studies should not be required for such bridging studies.
Similar content being viewed by others
References
Hu P, Wang J, Florian J, Shatzer K, Stevens AM, Gertz J, et al. Systematic review of device parameters and design of studies bridging biologic-device combination products using prefilled syringes and autoinjectors. AAPS J. 2020;22:52. https://doi.org/10.1208/s12248-020-0433-8.
Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development, Draft Guidance for Industry and FDA Staff, February 2016. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/human-factors-studies-and-related-clinical-study-considerations-combination-product-design-and. Accessed 26 March 2020.
Bridging for Drug-Device and Biologic-Device Combination Products, Guidance for Industry, FDA, December 2019. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/bridging-drug-device-and-biologic-device-combination-products. Accessed 26 March 2020.
Author information
Authors and Affiliations
Corresponding author
Additional information
Publisher’s Note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
Rights and permissions
About this article
Cite this article
Lambert, W.J. Why Do the Majority of Submissions for Bridging from a Prefilled Syringe to an Autoinjector Include Bioequivalence Studies in Order to Demonstrate Comparability?. AAPS J 22, 72 (2020). https://doi.org/10.1208/s12248-020-00453-0
Received:
Accepted:
Published:
DOI: https://doi.org/10.1208/s12248-020-00453-0