FDA Approves First Copaxone Generic for Multiple Sclerosis

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The approval comes after Teva Pharmaceuticals filed eight citizen petitions and fought several court battles to protect Copaxone.

Despite a hard fought battle by Teva Pharmaceuticals, the U.S. FDA approved the first generic formulation of Copaxone (glatiramer acetate injection), the Israeli company’s blockbuster multiple sclerosis (MS) drug.

Together with Momenta Pharmaceuticals, Novartis’ Sandoz unit won the approval for Glatopa, its 20 mg/1 mL daily injection meant for treating relapsing-remitting MS. Another generic, manufactured by Dutch company Synthon, is still awaiting approval.

The high-profile approval comes after Teva filed eight citizen petitions and fought several court battles to try and keep potential generic drug makers from bringing their versions of Copaxone to market as it wrestled with an expiring patent. As recent as January, Teva seemed to have had the upper hand in the battle, winning a U.S. Supreme Court ruling that protected its current patent while it was busy converting patients to a new, stronger, and patent-protected formulation.

With much at stake, the FDA said it took extra care to assure that the complex active ingredient in the generic was the same as what’s found in Copaxone. The generic formulation has similar adverse reactions as Copaxone, including irritation at the injection site, flushing, rash, shortness of breath, and chest pain.

“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,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a statement. “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.”

For more information:

  1. FDA Press Release
  2. Sandoz Press Release