Sandoz releases Copaxone generic

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HOLZKIRCHEN, Germany — Following Food and Drug Administration final approval, Sandoz has launched of Glatopa 40 mg/ml (glatiramer acetate injection), a multiple sclerosis medication.

The Novartis division said Tuesday that Glatopa 40 mg/ml, manufactured in the United States, was developed under a collaboration pact with Momenta Pharmaceuticals Inc. The product is a fully substitutable generic version of Copaxone (glatiramer acetate injection 40 mg/ml) from Teva Pharmaceutical Industries Ltd., according to Sandoz.

A three times weekly therapy, 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, Sandoz said.

The company noted that patients can expect the same patient services for Glatopa 40 mg/ml as for Glatopa 20 mg/ml, which became available in the U.S. in June 2015.

“The approval and launch of Glatopa 40 mg/ml reinforces our leadership in delivering complex, differentiated generic products,” Sandoz chief executive officer Richard Francis stated. “We look forward to bringing this product to patients and health care professionals and providing a full range of patient support services for Glatopa through GlatopaCare.”

Sandoz GlatopaCare will offer a $0 co-payment support program to qualified patients. The company said participating 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.



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