Characterization of biosimilars: Description of the analytical approach
1 Mohammed Lamine DEBAGHINE University Hospital Center, ALGIERS, ALGERIA.
2 Analytical Chemistry laboratory, Faculty of Medicine, BLIDA, ALGERIA.
Review Article
GSC Biological and Pharmaceutical Sciences, 2023, 25(02), 215–221.
Article DOI: 10.30574/gscbps.2023.25.2.0482
Publication history:
Received on 04 October 2023; revised on 12 November 2023; accepted on 15 November 2023
Abstract:
Biological drugs stand out from chemically synthesized drugs by their complexity. The latter puts developers, manufacturers, and controllers of drugs facing really scientific and technological challenges to ensure a safe, effective, and high-quality product. Regulatory agencies evaluate biosimilars based on their level of similarity to the innovative drug, rather than their exact resemblance to it. The recommendations of the Food and Drugs Administration indicate that, when evaluating the product, “The totality of the evidence” will be considered.
With the aim of providing access to cheaper treatment options for patients, the development of biosimilar now focuses on characterization analytical by comparing structural and functional similarities with the product reference biological as it has already undergone the efficacy tests required for its initial approval. Advances in analytical techniques allow for detailed characterization and the identification of differences that may affect the purity, safety, and efficacy of biological product potentially similar to the reference product.
Comparative clinical trials will only take place when the regulatory authority considers them necessary as they are expensive and require more development time, which will against the aim of creating more available and affordable treatment options for patients. In this presentation, the notion of comparability of these agents and their analytical characterization will be presented.
Keywords:
Biosimilar; Comparability; Analytical characterization; Critical quality attributes
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Copyright © 2023 Author(s) retain the copyright of this article. This article is published under the terms of the Creative Commons Attribution Liscense 4.0
