For decades, policies regarding generic medicines have sought to provide patients with economical access to safe and\neffective drugs, while encouraging the development of new therapies. This balance is becoming more challenging for\nphysicians and regulators as biologics and non-biological complex drugs (NBCDs) such as glatiramer acetate demonstrate\nremarkable efficacy, because generics for these medicines are more difficult to assess. We sought to develop computational\nmethods that use transcriptional profiles to compare branded medicines to generics, robustly characterizing differences in\nbiological impact. We combined multiple computational methods to determine whether differentially expressed genes\nresult from random variation, or point to consistent differences in biological impact of the generic compared to the branded\nmedicine. We applied these methods to analyze gene expression data from mouse splenocytes exposed to either branded\nglatiramer acetate or a generic. The computational methods identified extensive evidence that branded glatiramer acetate\nhas a more consistent biological impact across batches than the generic, and has a distinct impact on regulatory T cells and\nmyeloid lineage cells. In summary, we developed a computational pipeline that integrates multiple methods to compare\ntwo medicines in an innovative way. This pipeline, and the specific findings distinguishing branded glatiramer acetate from\na generic, can help physicians and regulators take appropriate steps to ensure safety and efficacy.
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