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Comparing the Biological Impact of Glatiramer Acetate with the Biological Impact of a Generic
For decades, policies regarding generic medicines have sought to provide patients with economical access to safe and effective drugs, while encouraging the development of new therapies. This balance is becoming more challenging for physicians and regulators as biologics and non-biological complex dr...
Autores principales: | , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Public Library of Science
2014
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3885444/ https://www.ncbi.nlm.nih.gov/pubmed/24421904 http://dx.doi.org/10.1371/journal.pone.0083757 |
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author | Towfic, Fadi Funt, Jason M. Fowler, Kevin D. Bakshi, Shlomo Blaugrund, Eran Artyomov, Maxim N. Hayden, Michael R. Ladkani, David Schwartz, Rivka Zeskind, Benjamin |
author_facet | Towfic, Fadi Funt, Jason M. Fowler, Kevin D. Bakshi, Shlomo Blaugrund, Eran Artyomov, Maxim N. Hayden, Michael R. Ladkani, David Schwartz, Rivka Zeskind, Benjamin |
author_sort | Towfic, Fadi |
collection | PubMed |
description | For decades, policies regarding generic medicines have sought to provide patients with economical access to safe and effective drugs, while encouraging the development of new therapies. This balance is becoming more challenging for physicians and regulators as biologics and non-biological complex drugs (NBCDs) such as glatiramer acetate demonstrate remarkable efficacy, because generics for these medicines are more difficult to assess. We sought to develop computational methods that use transcriptional profiles to compare branded medicines to generics, robustly characterizing differences in biological impact. We combined multiple computational methods to determine whether differentially expressed genes result from random variation, or point to consistent differences in biological impact of the generic compared to the branded medicine. We applied these methods to analyze gene expression data from mouse splenocytes exposed to either branded glatiramer acetate or a generic. The computational methods identified extensive evidence that branded glatiramer acetate has a more consistent biological impact across batches than the generic, and has a distinct impact on regulatory T cells and myeloid lineage cells. In summary, we developed a computational pipeline that integrates multiple methods to compare two medicines in an innovative way. This pipeline, and the specific findings distinguishing branded glatiramer acetate from a generic, can help physicians and regulators take appropriate steps to ensure safety and efficacy. |
format | Online Article Text |
id | pubmed-3885444 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2014 |
publisher | Public Library of Science |
record_format | MEDLINE/PubMed |
spelling | pubmed-38854442014-01-13 Comparing the Biological Impact of Glatiramer Acetate with the Biological Impact of a Generic Towfic, Fadi Funt, Jason M. Fowler, Kevin D. Bakshi, Shlomo Blaugrund, Eran Artyomov, Maxim N. Hayden, Michael R. Ladkani, David Schwartz, Rivka Zeskind, Benjamin PLoS One Research Article For decades, policies regarding generic medicines have sought to provide patients with economical access to safe and effective drugs, while encouraging the development of new therapies. This balance is becoming more challenging for physicians and regulators as biologics and non-biological complex drugs (NBCDs) such as glatiramer acetate demonstrate remarkable efficacy, because generics for these medicines are more difficult to assess. We sought to develop computational methods that use transcriptional profiles to compare branded medicines to generics, robustly characterizing differences in biological impact. We combined multiple computational methods to determine whether differentially expressed genes result from random variation, or point to consistent differences in biological impact of the generic compared to the branded medicine. We applied these methods to analyze gene expression data from mouse splenocytes exposed to either branded glatiramer acetate or a generic. The computational methods identified extensive evidence that branded glatiramer acetate has a more consistent biological impact across batches than the generic, and has a distinct impact on regulatory T cells and myeloid lineage cells. In summary, we developed a computational pipeline that integrates multiple methods to compare two medicines in an innovative way. This pipeline, and the specific findings distinguishing branded glatiramer acetate from a generic, can help physicians and regulators take appropriate steps to ensure safety and efficacy. Public Library of Science 2014-01-08 /pmc/articles/PMC3885444/ /pubmed/24421904 http://dx.doi.org/10.1371/journal.pone.0083757 Text en © 2014 Towfic et al http://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are properly credited. |
spellingShingle | Research Article Towfic, Fadi Funt, Jason M. Fowler, Kevin D. Bakshi, Shlomo Blaugrund, Eran Artyomov, Maxim N. Hayden, Michael R. Ladkani, David Schwartz, Rivka Zeskind, Benjamin Comparing the Biological Impact of Glatiramer Acetate with the Biological Impact of a Generic |
title | Comparing the Biological Impact of Glatiramer Acetate with the Biological Impact of a Generic |
title_full | Comparing the Biological Impact of Glatiramer Acetate with the Biological Impact of a Generic |
title_fullStr | Comparing the Biological Impact of Glatiramer Acetate with the Biological Impact of a Generic |
title_full_unstemmed | Comparing the Biological Impact of Glatiramer Acetate with the Biological Impact of a Generic |
title_short | Comparing the Biological Impact of Glatiramer Acetate with the Biological Impact of a Generic |
title_sort | comparing the biological impact of glatiramer acetate with the biological impact of a generic |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3885444/ https://www.ncbi.nlm.nih.gov/pubmed/24421904 http://dx.doi.org/10.1371/journal.pone.0083757 |
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