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.
“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.
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