Open-label 15-month follow-up of the double-blind, placebo-controlled Glatiramer Acetate clinical Trial to assess Equivalence with Copaxone® (GATE) trial.
To evaluate efficacy, safety, and tolerability of prolonged generic glatiramer acetate (GTR) treatment and to evaluate efficacy, safety, and tolerability of switching from brand glatiramer acetate (GA) to GTR treatment.
A total of 729 patients received GTR 20 mg/mL daily. Safety was assessed at months 12, 15, 18, 21, and 24 and Expanded Disability Status Scale and magnetic resonance imaging (MRI) scans at months 12, 18, and 24. The presence of glatiramer anti-drug antibodies (ADAs) was tested at baseline and months 1, 3, 6, 9, 12, 18, and 24.
The mean number of gadolinium-enhancing lesions in the GTR/GTR and GA/GTR groups was similar at months 12, 18, and 24. The change in other MRI parameters was also similar in the GTR/GTR and GA/GTR groups. The annualized relapse rate (ARR) did not differ between the GTR/GTR and GA/GTR groups, 0.21 and 0.24, respectively. The incidence, spectrum, and severity of reported adverse events did not differ between the GTR/GTR and GA/GTR groups. Glatiramer ADA titers were similar in the GTR/GTR and GA/GTR groups.
Efficacy and safety of GTR is maintained over 2 years. Additionally, switching from GA to GTR is safe and well tolerated.
Eventually the Patent Life of Glatiramer acetate has run out, its amazing that the lawyers have kept it going considering that the entity was created in the 1970s.
So whilst Teva has been busy convincing people to switch from once a day injection to thre times a week with abit more, the competitors have been making generic mixes to muscle in of the profits. This study looks at the turn coats that have turned their back on the branded version to go for the generic version because they don't like paying money for cardboard, which is the box it comes in, OK it may not come in carboard but hope you get the point. That they are the same thing in differnt packaging. However the originals will have it that the genrics are not the same and have done the experiments to show cytokine X or Y responds differntly between the cheap stuff. Anyway proof is in the pudding and so what happens in real life?
In reality nothing happened it was a seamless switch and when you look at the annualised relapse rates of 0.2 (1 releapse every 5 years). I may have to eat some words and say it is not that different from that shown with alemtuzumab in the trials which was 0.18, is it great however when you look at how i think it works then it isn't in the same league as alemtuzumab.
So maybe not out of the pan into the fire but from the badda bing to the bosch-whallop.
So will you swop?
I guess many will say if it ain't broken don't fix it and brand loyalty is what the companies hope for.