Synthon's generic Copaxone gets European approval

Synthon B.V. (Nijmegen, the Netherlands) said it received European approval of its 20 mg/mL glatiramer acetate, a generic version of Copaxone from Teva Pharmaceutical Industries Ltd. (NYSE:TEVA), to treat relapsing-remitting multiple sclerosis (RRMS). The company said all 29 member states in EMA's decentralized review process supported the generic's approval.

Synthon said it is the only company that has obtained European approval for a Copaxone generic. Spokesperson Fabienne Douven declined to disclose a price or launch date, but told BioCentury that Synthon would "commercialize through partners in line with our normal business model" and "respect any valid and enforceable patents." ...