“This is probably old news for you, but the FDA licensed a generic version of glatiramer acetate last week. The excerpts from the press article below cover the most important issues.”
Excerpts:
…… The generic version of the MS drug Copaxone will be sold under the brand name Glatopa by the Sandoz division of Switzerland’s Novartis AG, which signed an agreement with Cambridge-based Momenta to market the generic…..
….. Glatopa was approved as a “substitutable generic” for patients taking Copaxone, an injectable sold by Israel’s Teva Pharmaceutical Industries Ltd. for MS, a degenerative disease of the central nervous system. “Given its complexity, we reviewed additional information to make sure the generic product is as safe and effective as the brand-name product,” said Janet Woodcock, director of the Food and Drug Administration’s drug evaluation unit……
….. Sandoz and Momenta have not disclosed when they will launch Glatopa commercially in the United States or how it will be priced in relation to Copaxone, which competes with such MS drugs as Avonex from Biogen Inc. of Cambridge and Rebif from EMD Serono Inc. of Rockland…..
….. The list price for a year’s worth of Copaxone, which is injected daily, is more than $60,000 per patient. Insurers cover the bulk of the cost for most patients…….
…… “We won’t discuss our pricing strategies publicly ahead of launch but our general goal, as always, would be to offer patients and payers a real alternative to the originator,” said Julie Masow, a spokeswoman for Novartis…..
….. A long-running patent dispute pitting Teva against Sandoz and Momenta is working its way through the federal courts, but it’s not clear if that will delay the launch….
CoI: multiple
I'm not sure users have a choice and seems it will be up to the insurance companies if a generic Copaxone will be uses.I was initially concerned about using generic Copaxone, but after reading how the FDA evaluates this type of drug, my concerns are aleviated. Here is a link to the presentation:https://www.google.com/url?sa=t&source=web&rct=j&ei=hekwVZyzAcPyoATxloCIDA&url=http://www.gphaonline.org/media/cms/Larisa_Wu_1.pdf&ved=0CCEQFjAA&usg=AFQjCNEyAMA7XRZXeF57aJvDjGSWfIdVAg&sig2=I1U4eFw1WO5CiB-yVJ40Ig
> They simply felt the innovator compound was superior despite data showing similar levels of peripheral B cell depletion.We got many domestic (ronbetal, infibeta) and iranian (cinnovex) interferon formulations.Almost everyone with whom I talked on this, both patients and neuros, agree on that domestic biosimilars < iranian biosimilar < original formulations. The adhesion is poorer, side effects are less tolerable, patients do worse.All of them claimed to be as effective as originals as demonstrated in clinical trials, of course.All this could be biased, of course. But do the geography of those trials play a role? It is much easier to see the efficacy of the rituximab similars to deplete cells… And this is not the case with generic small molecules, but for biologicals used in chronic diseases like MS… i believe there is a question who and where do the trials.
I wonder what the animal data of the new generics is like.i wonder if they can get it to stop relapses when given after the first attack and in saline and given under the skinMaybe a reader can tell me where this data is as i dont easily find it
Look at the posters P.1.144 and P.1.145 presented at the ECTRIMS in Boston 2014.
These posters say that based on expression profiling of T cells copaxone and generic copaxone are essentially the same…so one can be reasonably confident that based on efficacy they are probably the same.. i.e, low efficacy.
I think this will be a fascinating natural experiment … but it's going to tell us more about the US health PAYMENT system than anything particular to MS or Copaxone. Specialty drugs – and the pricing / coverage / cost-sharing thereof – are nearing a flash point right now, with the hepatitis C drugs as the spark, and the collection of MS drugs as fuel for the fire once it starts. So long as we're in the existing payment scheme (and humor me and consider our hodge-podge as a single scheme), then my guess is that a 30% price drop will not be enough to significantly change much of anything. That will only happen if insurance companies place the generic GA as the ONLY MS drug in a lower tier than other DMTs. If they go the route of making generic GA the preferred formulation but placing it in the same tier as a preferred interferon (branded) and dimethyl fumerate (branded), then I'm guessing that a non-trivial number of Copaxone (40) users would opt to change drugs rather than stick to GA with daily dosing. Existing insurance schemes (tiered formularies and extreme cost sharing) leave DMTs out of reach for some and I don't see how the generic GA is going to change that unless we also see significant changes to insurance schemes. A 30% price drop still leaves it at ~$10,000 for a 3 month supply. Anyone with an insurance scheme based on percentage cost-share is just as SOL … that 30% price drop doesn't make it accessible to anyone for whom it isn't already accessible.
I'm a little concerned. I was eager to take 40mg GA–who wouldn't be? But after about a week, I had a mild reaction (itchy, redness, and a few hives). It didn't make sense to me, but my neuro put me back on 20mg, and I've been fine ever since. I get allergic to weird things lately–terrible reactions to gadolinium, too. So the prospect of changing any drugs worries me. My guess is that my insurer (I'm in the US) will require me to take the generic.