Generic receives marketing authorisation in Europe for treatment of MS

Global pharmaceutical company, Mylan, has announced that its partner Synthon has received European marketing authorisation approval for its generic, Glatiramer Acetate injection, to treat patients with relapsing forms of multiple sclerosis (MS).

“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,” said Heather Bresch, Mylan CEO. “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.”

Glatiramer Acetate Injection 40 mg/mL is a therapeutically equivalent generic version of Teva’s Copaxone 40 mg/mL. This recent approval follows the approval the company received last year for the 20 mg/mL generic, which is already available in several European markets.

The company expects national marketing authorisations to follow in the near future.