All 29 member states included in the decentralized procedures supported approval of the product.
The authorities’ approval formally acknowledges that Synthon’s glatiramer acetate is regarded therapeutically equivalent to the reference product based on the Quality, Non-Clinical and Clinical data submitted in the application.
Synthon conducted a large-scale, multicenter Phase III study, known as GATE (Glatiramer Acetate clinical Trial to assess Equivalence to Copaxone).
Results of the study demonstrate equivalence in efficacy and safety and support the safety of switching active therapy from Copaxone to Synthon’s glatiramer acetate. Synthon is the only company to have performed such a study for glatiramer acetate and to obtain regulatory clearance in Europe.
Synthon chief executive officer Jacques Lemmens said: "This approval is testimony to the quality and similarity of our glatiramer acetate, which is the only clinically validated alternative to Copaxone in Europe.
"It is a landmark for Synthon and for MS patients throughout Europe, who are in anticipation of a more affordable treatment for this chronic, unpredictable, and debilitating disease."