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Monday, September 12, 2016

1st Generic for Copaxone to Treat Relapsing MS Available in Central and Eastern Europe


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Alvogen recently announced the launch of Remurel (glatiramer acetate) in Central and Eastern Europe, making it the first generic equivalent of Copaxone  to be clinically validated for the treatment of relapsing forms of multiple sclerosis (RRMS) in Europe.
European health authorities determined that Remurel 20 mg was the therapeutic equivalent to daily Copaxone 20 mg (glatiramer acetate, Teva Pharmaceuticals), with the same active ingredients, route of administration, strength, and dosage form. The approval is supported by results from a large-scale, multicenter Phase 3 clinical trial (GATE)(NCT01489254).
The GATE (Glatiramer Acetate clinical Trial to assess Equivalence to Copaxone) study demonstrated the efficacy and safety of Remurel in comparison to Copaxone, and in that of switching from the older therapy to Remurel.

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