Teva Pharmaceuticals announced the release of data demonstrating substantial differences in biological and immunological effects concerning its product Copaxone (glatiramer acetate, GA) and a generic GA commercialized in India. Copaxone is indicated for decreasing relapse frequency in relapsing remitting multiple sclerosis (MS). Multiple sclerosis affects more than 2 million people all over the world. The published data holds possibilities for clinical ramifications.
The data was published in the online scientific journal PLOS ONE last week and details the results of gene expression analysis from mice splenocytes exposed to Copaxone or the generic GA. The data demonstrates Copaxone’s largely predictable and therapeutically aligned impact on key genes associated with regulatory T cells (Tregs) and myeloid lineage cells. On the contrary, the generic GA manifested irregular and dissimilar impact on the immune response-related cells.
Teva Pharmaceutical Chief Scientic Officer and Global R&D President Dr. Michael Hayden said, “The data from this paper shows the possible significant ramifications of changes in physiochemical properties between Copaxone and a purported generic GA.” Dr. Hayden is also one of the authors of the study. “This study suggests a distinct potential difference in the impact of a purported generic GA on the immune system of patients, with possible implications on efficacy and safety in RRMS patients. Teva believes the only way to truly understand the impact of these differences is by conducting a full battery of clinical studies.”
Dr. Ben Zeskind, Immuneering Corporation CEO and co-author of the study, said, “This extensive analysis indicates, in my view, a concerning lack of consistency and predictability in the purported generic GA's effect on key elements of the murine immune system. Furthermore, variability seen in the expression of certain genes, from one batch of the purported generic GA to another, raises the possibility that patients may not receive the same treatment effect with each dose.”
Full details of the study can be found at Plos One. The research was commissioned and funded by Teva.