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FDA Approves New Generic for Copaxone®

A new generic version of the disease modifying treatment (DMT) Copaxone (glatiramer acetate) was approved by the FDA on October 3, 2017.1 Mylan, a pharmaceutical company that specializes in developing generics, developed both a 20 mg/mL once-daily dose and a 40 mg/mL three-times-a-week dose. The approval comes just two days after the commissioner of the FDA, Scott Gottlieb, asserted that high drug prices are “a public health concern that the FDA should address.” 2

Previously, Copaxone had only one generic equivalent approved in 2015 for its 20 mg/mL dose. That generic, Glatopa, was not substitutable for the 40mg/mL dose of Copaxone.3 Copaxone is currently the most prescribed therapy for those with relapsing remitting MS.1 Mylan has not yet disclosed the cost of their glatiramer acetate injections, but healthcare providers and patients are optimistic that the generic will come with a significant price decrease.

  1. Mylan Announces U.S. FDA Approval of First Generic for Copaxone® 40 mg/mL 3-Times-a-Week and May Be Eligible for 180-Day Exclusivity. PR Newswire. October 3, 2017.
  2. Burton, Thomas. FDA Chief Says High Drug Prices ‘Public Health Concern’ Agency Should Address. The Wall Street Journal. October 2, 2017.
  3. Glatopa. National Multiple Sclerosis Society. Accessed October 2017.