FDA approves Copaxone for MS; problems persist

April 16, 2015

The FDA today approved the first generic version of Copaxone (glatiramer acetate injection) for treating patients with relapsing forms of multiple sclerosis (MS) on April 16.

FDA approved the first generic version of Copaxone (glatiramer acetate injection) for treating patients with relapsing forms of multiple sclerosis (MS).

Manufacturer Sandoz with Momenta has received FDA approval to market generic glatiramer acetate, or Glatopa, in a 20-mg/1-ml daily injection.

However, Sandoz may not be able to market the drug in the United States in the near future. A court ruling that shifted Copaxone's (manufactured by Teva) patent expiration from September 2015 to May 2014 is still in question, according to FiercePharma.

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“The longer Glatopa takes to roll out, the more time Teva will have to switch patients over to a new, long-acting version of the drug – something it's been working on since it won FDA approval last January. So far, the company has made quick work, converting more than 67% of patients,” FiercePharmawrote, citing Evercore analyst Umer Raffat’s note on Copaxone.

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Meanwhile, for approving the generic Copaxone, FDA scientists established a thorough scientific approach for demonstrating active ingredient sameness that takes into consideration the complexity of glatiramer acetate, the agency said in a statement.

In the clinical trials for Copaxone, the most common adverse reactions reported by those taking Copaxone were skin problems at the injection site (redness, pain, swelling and itching), flushing (vasodilation), rash, shortness of breath and chest pain.