Posted by Michael Wonder on 07 Oct 2017
Mylan, in partnership with Synthon, receives marketing authorisation approval in Europe for first generic for Copaxone 40 mg/mL
5 October 2017 - Mylan has exclusive rights for glatiramer acetate in several key European markets.
Mylan today announced that partner, Synthon, received marketing authorisation approval in Europe for glatiramer acetate Injection 40 mg/mL, a therapeutically equivalent generic version of Teva's Copaxone 40 mg/mL, indicated for the treatment of patients with relapsing forms of multiple sclerosis, a chronic inflammatory disease of the central nervous system.
This approval complements last year's approval of glatiramer acetate Injection 20 mg/mL, which already is available in several European markets.
Granting of national marketing authorisations is expected to follow in the near future.
