Out of the Frying Pan into the Fire?

Selmaj K, Barkhof F, Belova AN, Wolf C, van den Tweel ER, Oberyé JJ, Mulder R, Egging DF, Koper NP, Cohen JA; GATE study group. Switching from branded to generic glatiramer acetate: 15-month GATE trial extension results.Mult Scler. 2017 Jan 1:1352458516688956.


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.

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  • placebo controlled? dear god, what are these people doing to people with ms in the supposedly ethical name of science?

    • I wonder the same thing, but we know it's because none of Big Pharma wants to put their drug fireproof against another more or less effective.
      In the meantime, anyone who participates in studies like this has the "chance" to have an releapse, to have sequelae and nobody wants to take responsibility for it after all.

    • If you use an active comparator you have to pay for it. In the cladribine trial we had 300 people drug cost 800 euro so 240000 about 2 million we planned head to head with 300 alemtuzumab cost £60000 so 18,000,000 drug cost as the NIHR would pay for standard of care we could do the trial for 4 million. So doing the trial would save UK PLC £12,000,000 because 300 people would not be getting alemtuzumab. In fact it was 600 people as had two arms so saving 28,000,000. The thick revised could so see how the saving could be that much intact it would be more because there are at least £20000 per person on alemtuzumab dealing with side effect or problems and monitoring.

      For a few million you could have sufficient evidence to make a guaranteed impact yet the funders are happy to put a few million into trials that are intuitively unlikely to have much impact and go no where fast. But the trial was 2 million too expensivem

  • So what does it really say about ethical review committees time and time again this happens..This comment with bite me.

  • Could you say more about what you mean by, "when you look at hoe it works it's not in the same league as alemtuzumab"? I am about to switch from copaxone to lemtrada and understood that lemtrada is much more effectiv so I'm interested in the equivalence this study shows in relapse rate. What is it, in your opinion, that puts lemtrada in a diferent league?

    • In the post I was commenting on the relapse rate of 0.2 in the pivotal MS trial with alemtuzumab the relapse rate was 0.18.

      However, this shows you why you can't compare one trial to another, because I very much doubt that coxpone would be anywhere near alemtuzumab if they went head to head in a similar group of pwMS.

      I think that Alemtuzumab is one of the strongest inhibitors of relapsing MS and the the CRAB drugs are amongst the worst.

      However with increased efficacy comes the risk of more side-effects such as infections and with alemtuzumab there are secondary autoimmunities risk also. But the prospect of being drug free with MS under control or gone is appealing to me

      Why is it in a different league..Potential Efficacy, perhaps more convenience, but this is offset by the increased screening requirements
      of lemtrada etc. But we can do better.

      "When you look how it works"…I am afraid you will need to wait a little bit until the specific concept is published. The data is all out as is the concept

      Once out (depends on referees) You can then read the idea , see the data and see if it makes sense. I then add extra data on the blog so you can make your own mind up.

      It could all be rubbish. It maybe is something you all know already

      Hopefully you the readers can see if it is a mad idea. Hopefully people like Steve S will do research and find the holes in the argument, on perhaps more info to support the idea. We can then do posts that breaks the bubble of adds more meat on the argument

      The posts are written and ready to go. Then you can make up your own mind if you agree with the mechanism of action. This is not a tease…it is the publication process where we must respect embargo because if we say too much and put it on blog then the publishers am through it in the bin again.

  • Placebo controlled seems more than a tad unethical to me. But hey, anyone on the trial who has a relapse will want to be escalated to something more effective than GA afterwards (not knowing whether GA or placebo on trial) so GA pharma risk losing out in the longterm

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