Synthon gains European approval for generic version of Copaxone for MS

12 April 2016

Dutch generics company Synthon has announced that glatiramer acetate, a generic version of the blockbuster drug Copaxone (glatiramer acetate), for the treatment of relapsing remitting multiple sclerosis, has gained approval in Europe.

It has concluded the decentralized procedures for the drug, and all 29 member states involved have supported approval of the product.

This approval formally acknowledges that, based on trial data submitted in the application, Synthon’s glatiramer acetate is regarded as therapeutically equivalent to Copaxone, which was developed and is marketed by Israel's Teva Pharmaceutical Industries (NYSE: TEVA)

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