Review
Version 1
Preserved in Portico This version is not peer-reviewed
Molecular Biosimilarity--A Paradigm Shift
Version 1
: Received: 9 August 2022 / Approved: 10 August 2022 / Online: 10 August 2022 (05:19:49 CEST)
A peer-reviewed article of this Preprint also exists.
Niazi, S.K. Molecular Biosimilarity—An AI-Driven Paradigm Shift. Int. J. Mol. Sci. 2022, 23, 10690. Niazi, S.K. Molecular Biosimilarity—An AI-Driven Paradigm Shift. Int. J. Mol. Sci. 2022, 23, 10690.
Abstract
Scientific, technical and bioinformatics advances have made it possible to establish analytics-based molecular biosimilarity for the approval of biosimilars. If the molecular structure and other product- and process-related attributes are comparable within the limits of testing then a biosimilar candidate would have safe safety and efficacy as its reference products. The current model of animal and human testing becomes redundant since all of these studies have much lower sensitivity and reproducibility in confirming biosimilarity. The recent AI-based protein structure prediction model has confirmed that the 3D structure can be predicted from the amino acid sequence, reducing the need for structural analysis; however, the new test methods based on MS are millions of times more sensitive and accurate. While the regulatory agencies have begun waiving animal testing and, in some cases, clinical efficacy testing, removing clinical pharmacology profiling brings a dramatic paradigm shift, reducing development costs without compromising safety and efficacy. Also shared is a list of 160+ products ready to enter as biosimilars. Major actions from regulatory agencies and developers are required to make this paradigm shift.
Keywords
biosimilar; analytical assessment; animal testing; clinical pharmacology; clinical efficacy; FDA; EMA; MHRA; WHO
Subject
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.
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