Generic Copaxone Approved by the FDA

[Marco]

My understanding is that the legal battle has already occurred and Teva won.

A patent lawsuit is ongoing. A federal appeals court is reviewing whether a key Teva patent, which expires in September, is valid. If the patent is upheld, Sandoz would have to decide whether to risk another lawsuit – and potentially substantial damages – by selling a generic before September. A spokeswoman for Sandoz, which handles marketing, declined to comment on the timetable.


Wheeler also declined to discuss timing, but indicated the companies are ready to launch. He adds that the appeals court set an accelerated date for review, suggesting that a decision could occur in coming weeks. As for Teva, a spokeswoman writes us that “any companies that launch a generic version of Copaxone would do so at risk.” She declined to comment further or say when a ruling may be expected.

from: http://blogs.wsj.com/pharmalot/2015/...ome-available/

[Sir-Voor]

FDA: “Health care professionals and patients can be assured that FDA-approved generic drugs have met the same rigorous standards of quality as the brand-name drug,”

That is a big LIE! In may be legally true, because they “have met” instead of “will have”, but the intent to deceive it there and that make it a big fat lie!
FDA only requires generic drug companies to prove that they can make it, and not they are making it.
No random quality test, No requirement to show that they buying the ingredients, No review what so ever.

I know this may sound like good news to some, but for me it is bad news.

[Mamabug]

Marco --

Thanks for sharing.

My understanding is that the legal battle has already occurred and Teva won. My MS Specialist at KU Med Center talked about that in March, when I went for my appointment.

But, I must not be understanding the whole picture. If there already has been a legal battle, I'm not sure how the FDA approval to market, that occurred today, fits in. Because I would have assumed that approval would have happened in the past, prior to the law suit.

Can you explain to this numbskull how that all fits together? Or, is there a good link you could point me to?

Thanks.

[its2much]

Wonder what the Price

will be by Sandoz (Don't they have to make up what it cost them to develop the generic?). Will it be that much of a savings per month or will it just be a reason for insurance companies to no longer pay for the brand name?

[Marco]

The U.S. Food and Drug Administration today approved the first generic version of Copaxone (glatiramer acetate injection), used to treat patients with relapsing forms of multiple sclerosis (MS). Sandoz has received FDA approval to market generic glatiramer acetate in a 20 mg/1 ml daily injection.


“Health care professionals and patients can be assured that FDA-approved generic drugs have met the same rigorous standards of quality as the brand-name drug,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “Before approving this generic product, given its complexity, we reviewed additional information to make sure that the generic product is as safe and effective as the brand name product.”




http://www.fda.gov/NewsEvents/Newsro.../ucm443143.htm

Even though the drug is approved, there are still legal hurdles to clear before it will come to market. Teva is not going to give up $3.1 billion in 2014 sales without a fight. Teva has been trying to move as many Copaxone patients to their newer 40-mg formula to preserve it's marketshare. Teva had hoped to switch 80% of their users to the longer acting 40 mg variant. Estimates suggest that 67% of users have switched to the newer dose. The Copaxone-40 has patent protection for another 15 years.

In the next few years, patents for Rebif, Betaseron, Extavia and Avonex will all expire and hopefully equivalent and cheaper generics will hit the market. The MS community needs cheaper medications without patent and pricing gimmicks. Hopefully, we will not experience more shenanigans like we saw with Rituxan, Campath or Acthar Gel.