Before lengthy legal battles between Teva Pharmaceuticals and drug manufacturers eager to claim a portion of the lucrative MS drug market have been completely resolved, the FDA announced late on Thursday, April 16, 2015, approval of the first generic version of Copaxone (glatiramer acetate injection).
Sandoz, a subsidiary of Novartis, has received FDA approval to market Glatopa, a generic version of glatiramer acetate in a 20 mg/ml daily injection. Developed in collaboration with Momenta Pharmaceuticals and produced entirely in the US, Glatopa is indicated for the treatment of patients with relapsing forms of MS, including patients with clinically isolated syndrome.
Mylan Inc, in collaboration with Natco Pharma Ltd, is also working on generic versions of Copaxone. I say versions, plural, because last August 2014, Mylan, Momenta and Sandoz announced that the FDA had accepted their ANDAs (abbreviated new drug application) for three-times-a-week generic Copaxone.
“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 [Glatopa], given its complexity, we reviewed additional information to make sure that the generic product is as safe and effective as the brand name product.”
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FDA Approves Glatopa (aka generic Copaxone) for Relapsing MS