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Equivalent Gene Expression Profiles between Glatopa™ and Copaxone®.

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|October 17, 2015
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Glatopa, a generic glatiramer acetate, demonstrated equivalent gene expression profiles to Copaxone in a study using murine T cells. This suggests Glatopa is a comparable treatment for relapsing multiple sclerosis.

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Area of Science:

  • Immunology
  • Genomics
  • Pharmacology

Background:

  • Glatopa (glatiramer acetate) is a new generic treatment for relapsing multiple sclerosis.
  • Evaluating the equivalence of generic drugs to their reference counterparts is crucial.

Purpose of the Study:

  • To assess the gene expression equivalence between Glatopa and Copaxone using a relevant biological model.
  • To confirm the sensitivity of the gene expression profiling assay.

Main Methods:

  • Gene expression profiling using microarray analysis on murine Th2-polarized T cells.
  • Statistical analyses including Student's t-test, principal component analysis, multidimensional scaling, and hierarchical clustering.
  • Comparison of Glatopa, Copaxone, and a nonequivalent glatiramoid control.

Main Results:

  • Copaxone significantly modulated numerous gene expressions compared to media control.
  • No significant differences in gene expression profiles were found between Glatopa and Copaxone.
  • Glatopa and Copaxone significantly differed from the nonequivalent glatiramoid control, confirming assay sensitivity.

Conclusions:

  • Glatopa exhibits equivalent gene expression profiles to Copaxone.
  • The study supports the biological equivalence of Glatopa and Copaxone for multiple sclerosis treatment.