Why generic MS drugs won't be cheap

[shoshin]

Here is an interesting article that explains why generic interferons or Tysabri won't be cheap.

http://www.scientificamerican.com/article.cfm?id=fda-to-approve-new-generics

Basically, they're biologic drugs and their production can't be reduced to a chemical formula and a mechanical set of steps. Because "biological drugs are manufactured in living cells, there can be tremendous variation in the drug molecules produced."

This means that any generic biologic drug will have to go through expensive clinical trials so "The Federal Trade Commission estimates that generic biological drugs are 'unlikely to introduce...discounts any larger than between 10 and 30 percent of the pioneer product’s price.' Nevertheless, those small savings may add up to $300 billion by 2029, according to some estimates, and future technologies that make it easier to assess the structure and function of a protein could add to those savings."

And as an example of what can go wrong
"In 2003 Johnson & Johnson learned the hard way that a seemingly small change to the manufacturing process can have devastating consequences. In manufacturing Procrit, a biological treatment for anemia, the company substituted one stabilizing agent for another, which was thought to be safe. Studies later found that 16 percent of Procrit users suffered sudden and sometimes fatal reactions to the drug. After the drug had gone to market, researchers learned that the new stabilizer had unexpectedly reacted with other ingredients, creating substances that caused immunogenic responses and intracranial hemorrhaging in some patients."

Interestingly, "because they are derived from living sources, most biological drugs will be recognized as foreign invaders by the patient’s immune system."

Copaxone is the MS drug likely to go generic soonest. It seems to be like, but not quite, a biologic drug and I found some posts debating how it will be treated. Here's another take: http://ms.about.com/b/2011/06/21/generic-copaxone-on-the-way.htm

sho

[COBOB]

Copaxone is not a biologic.  It is a polypeptide formed by a combination of 4 amino acids.  So it may actually make a good cost case as a generic.  I think that is the main reason Teva has it jammed up in the courts.  It is much easier to produce than the interferons or the monoclonal antibodies.

Bob

[Guitar_grrrl]

Sheesh!  It's all too expensive!  I'm not sure I'm willing to play with any of the slightly modified versions, either.  Unless they put them through double blinded studies, etc., and then it might as well be a whole new drug! Grrr...

[sllowe]

Thanks, Sho. Personally, I'm hoping rebif never goes generic.
Last I read Copax was still in the courts - hope they fair well. I'm not comfortable w/generics on disease modifiers. And, maybe I'm not versed enough, but hope they don't get it though at all.
I look fwd cking out the link, and learning more.
-shell