Version 1
: Received: 28 April 2023 / Approved: 28 April 2023 / Online: 28 April 2023 (08:03:20 CEST)
How to cite:
Niazi, S.K. Functional Biosimilarity to Replace Clinical Efficacy Testing of mAb Biosimilars: Advancing the FDA Perspective. Preprints2023, 2023041141. https://doi.org/10.20944/preprints202304.1141.v1
Niazi, S.K. Functional Biosimilarity to Replace Clinical Efficacy Testing of mAb Biosimilars: Advancing the FDA Perspective. Preprints 2023, 2023041141. https://doi.org/10.20944/preprints202304.1141.v1
Niazi, S.K. Functional Biosimilarity to Replace Clinical Efficacy Testing of mAb Biosimilars: Advancing the FDA Perspective. Preprints2023, 2023041141. https://doi.org/10.20944/preprints202304.1141.v1
APA Style
Niazi, S.K. (2023). Functional Biosimilarity to Replace Clinical Efficacy Testing of mAb Biosimilars: Advancing the FDA Perspective. Preprints. https://doi.org/10.20944/preprints202304.1141.v1
Chicago/Turabian Style
Niazi, S.K. 2023 "Functional Biosimilarity to Replace Clinical Efficacy Testing of mAb Biosimilars: Advancing the FDA Perspective" Preprints. https://doi.org/10.20944/preprints202304.1141.v1
Abstract
The FDA has concluded that a biosimilar candidate capable of demonstrating pharmacodynamic biomarkers in a healthy subject need not be tested for clinical efficacy in patients, regardless of if the biomarker correlates with clinical response. Since monoclonal antibodies (mAbs) do not trig-ger pharmacodynamic response, they can be substituted with robust functional disqualifying them for this waiver that can be overcome by allowing comparison of functional properties that eventually result in clinical response. This suggestion is based on the FDA's preference for more sensitive testing methods. However, clinical efficacy testing in patients is the least sensitive method, as confirmed by statistical modeling, a fact that regulatory agencies need to admit. In this paper, I present a logical and rational argument to establish the biosimilarity of products that do not have pharmacodynamic biomarkers based on their orthogonally proven functional bio-similarity. This understanding will significantly lower the development cost of biosimilars, a goal that the FDA outlined in all its guidance.
Keywords: biosimilarity 1; biosimilars 2; pharmacodynamic biomarkers 3; monoclonal antibodies 4; FDA 5; clinical efficacy testing in healthy subjects 6; clinical efficacy testing in patients 7; functional assays 8; receptor binding 9.
Medicine and Pharmacology, Pharmacology and Toxicology
Copyright:
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
