FDA godkänner Glatopa, generiskt Copaxon för behandling av MS

Sandoz, a Novartis division, today announced the US FDA approval and launch of Glatopa® (glatiramer acetate injection)40 mg/mL.

Glatopa (glatiramer acetate injection)40 mg/mL is FDA-approved as a fully-substitutable, AP-rated generic version of Copaxone®*(glatiramer acetate injection) 40 mg/mL three times-a-week therapy for relapsing forms of multiple sclerosis (MS). Glatopa was developed under a collaboration agreement between Momenta Pharmaceuticals, Inc. and Sandoz and is produced in the US.

”The approval and launch of Glatopa 40 mg/mL reinforces our leadership in delivering complex, differentiated generic products. We look forward to bringing this product to patients and healthcare professionals and providing a full range of patient support services for Glatopathrough GlatopaCare®,” said Richard Francis, CEO, Sandoz.

Glatopa 40 mg/mL is indicated for the treatment of patients with relapsing forms of multiple sclerosis. Glatopa 40 mg/mL, along with Glatopa 20 mg/mL, will offer patients a complete range of dosing options. Glatopa 20 mg/mL was made available in the US in June 2015. Patients can expect the same patient services for Glatopa 40 mg/mL as for Glatopa 20 mg/mL.

Sandoz GlatopaCare will offer a $0 co-pay support program to qualified patients. To help increase patient confidence with administering injections, patients will receive personalized injection training, 24-hour access to nurses for Glatopa®-related questions and a free Starter Kit, which includes the Glatopaject® injection device, designed to work with both Glatopa 20 mg/mL and 40 mg/mL prefilled syringes.