FDA approval of Sandoz Inc. and Momenta Pharmaceuticals Inc.’s Glatopa (glatiramer), the first generic of Teva Pharmaceutical Industries Ltd.’s Copaxone, came with a road map for demonstrating active ingredient sameness to the structurally complex multiple sclerosis drug.
The agency disagreed with Teva’s arguments in a series of citizen petitions that Copaxone’s complexity and structure preclude a determination of
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