FDA Approves Generic Version of Copaxone

On April 16, Novartis announced the Food & Drug Administration (FDA) approval of Glatopa, the first generic alternate for Teva’s widely used multiple sclerosis therapy, Copaxone. The once per day therapy was developed in collaboration between Novartis’ Sandoz unit and Momenta Pharmaceuticals for treatment of relapsing multiple sclerosis patients.

The only other generic available out of approximately 10 multiple sclerosis medications is for mitoxantrone. Copaxone accounts for approximately 30% of prescriptions, the largest for multiple sclerosis treatments. Launch timing and cost of Glatopa have yet to be released.

“We think there is really substantial demand across the board for getting a lower-cost generic product into the marketplace here,” said Craig A. Wheeler, the chief executive of Momenta.1,2

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