Cargando…

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...

Descripción completa

Detalles Bibliográficos
Autores principales: Towfic, Fadi, Funt, Jason M., Fowler, Kevin D., Bakshi, Shlomo, Blaugrund, Eran, Artyomov, Maxim N., Hayden, Michael R., Ladkani, David, Schwartz, Rivka, Zeskind, Benjamin
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2014
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
_version_ 1782298751732285440
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
work_keys_str_mv AT towficfadi comparingthebiologicalimpactofglatirameracetatewiththebiologicalimpactofageneric
AT funtjasonm comparingthebiologicalimpactofglatirameracetatewiththebiologicalimpactofageneric
AT fowlerkevind comparingthebiologicalimpactofglatirameracetatewiththebiologicalimpactofageneric
AT bakshishlomo comparingthebiologicalimpactofglatirameracetatewiththebiologicalimpactofageneric
AT blaugrunderan comparingthebiologicalimpactofglatirameracetatewiththebiologicalimpactofageneric
AT artyomovmaximn comparingthebiologicalimpactofglatirameracetatewiththebiologicalimpactofageneric
AT haydenmichaelr comparingthebiologicalimpactofglatirameracetatewiththebiologicalimpactofageneric
AT ladkanidavid comparingthebiologicalimpactofglatirameracetatewiththebiologicalimpactofageneric
AT schwartzrivka comparingthebiologicalimpactofglatirameracetatewiththebiologicalimpactofageneric
AT zeskindbenjamin comparingthebiologicalimpactofglatirameracetatewiththebiologicalimpactofageneric