Mylan, in Partnership with Synthon, Receives Marketing Authorization Approval in Europe for First Generic for Copaxone® 40 mg/mL
Mylan N.V. (NASDAQ, TASE: MYL) today announced that partner, Synthon, received marketing authorization 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 (MS), 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 authorizations is expected to follow in the near future.
Mylan CEO Heather Bresch commented, "We're pleased with the approval of Glatiramer Acetate Injection 40 mg/mL, and look forward to leading the marketing and selling of this important product in our European markets. Mylan recognizes the complexities of MS care and challenges faced by patients. This approval reinforces our commitment to helping patients and healthcare providers by providing alternative treatment options to better serve the needs of this community. The approval also highlights Mylan's commercial capabilities and ability to commercialize complex products around the globe."
Mylan is partnered with Synthon, the developer and supplier of its European Glatiramer Acetate Injection 20 mg/mL and 40 mg/mL products, and has exclusive distribution and supply rights for the products for Germany, France, Spain, Portugal, Belgium, Italy, the Netherlands, United Kingdom, Republic of Ireland, Switzerland, Greece, Denmark, Sweden, Norway, Finland, Cyprus and Malta.