Kolitz S, Hasson T, Towfic F, Funt JM, Bakshi S, Fowler KD, Laifenfeld D, Grinspan A, Artyomov MN, Birnberg T, Schwartz R, Komlosh A, Hayardeny L, Ladkani D, Hayden MR, Zeskind B, Grossman I. Gene expression studies of a human monocyte cell line identify dissimilarities between differently manufactured glatiramoids. Sci Rep. ;5:10191. doi: 10.1038/srep10191.
Glatiramer Acetate (GA) has provided safe and effective treatment for multiple sclerosis (MS) patients for two decades. It acts as an antigen, yet the precise mechanism of action remains to be fully elucidated, and no validated pharmacokinetic or pharmacodynamic biomarkers exist. In order to better characterize GA's biological impact, genome-wide expression studies were conducted with a human monocyte (THP-1) cell line. Consistent with previous literature, branded GA upregulated anti-inflammatory markers (e.g. IL10), and modulated multiple immune-related pathways. Despite some similarities, significant differences were observed between expression profiles induced by branded GA and Probioglat, a differently-manufactured glatiramoid purported to be a generic GA. Key results were verified using qRT-PCR. Genes (e.g. CCL5, adj. p < 4.1 × 10-5) critically involved in pro-inflammatory pathways (e.g. response to lipopolysaccharide, adj. p = 8.7 × 10-4) were significantly induced by Probioglat compared with branded GA. Key genes were also tested and confirmed at the protein level, and in primary human monocytes. These observations suggest differential biological impact by the two glatiramoids and warrant further investigation.
The Cop-wars are set to begin as the patents of glaterimer expire and the biosimilars arrive. However the cop-wars have been going for some time in the courts. Glaterimer is a random mix of cop-polymer and so is not the same from one batch to another however, the generics companies argue that their stuff is just as good the original. However this may not be the case.
They took 4 batches of GA and compared it with a single batch of probioglat and looked at the effect on a macrophage line and they show it activates a different set of cytokines over 120 were upregulated and over 20 down regulated(remember there is 30,000 genes. So they may not e the same.
It is argued that the efficacy rate in Mexico has dropped since the generics entered the Market. However as to highlight the conflicts in this paper this is by Teva employees and they do not compare GA verses Probioglat, which surely they have done as they want to convince us that "it is rubbish throw it in the bin".
So it can be argued if it is different would more batches give the same answer and now there other Cop Me-toos and these need to be checked
One company may argue that you are not paying more just for the packaging
Labels: generics, Glaterimer Acetate