The Novartis subsidiary said Thursday that the product (glatiramer acetate injection, 20 mg/ml) is the first generic version of Copaxone 20 mg, from Teva Pharmaceuticals.
Developed in collaboration with Momenta and made in the United States, Glatopa is indicated for the treatment of patients with relapsing forms of MS, including those who have experienced a first clinical episode and have magnetic resonance imaging (MRI) features consistent with MS.
“Sandoz, together with Momenta, is proud to announce the U.S. market launch of a fully substitutable generic version of this important therapy, following FDA approval,” said Sandoz US president Peter Goldschmidt stated.
MS is a debilitating disease affecting about a half-million people in the United States alone. Only half of those diagnosed are currently treated.
Sandoz said its service offering for Glatopa will include financial assistance to qualified patients, personalized injection training and 24-hour access to nurses for nonclinical questions.