Synthon’s generic version of Teva’s Copaxone has gained approval in 29 European countries.
Using an alternative route to marketing authorization, Synthon secured approval last week from all 28 EU member-states and the Netherlands, which is where the company is headquartered.
Pfizer has exclusive rights to commercialize Synthon’s product in the U.S.
The as yet unnamed drug would enter a multibillion dollar market spearheaded by Teva’s Copaxone, which earned $4 billion in revenue in 2015. Copaxone already faces generic competition in the U.S. from Sandoz, which launched Glatopa last June after a federal court invalidated Teva’s patent.