Generic Drug Approved for Relapsing Multiple Sclerosis

Today, Novartis announced the FDA granted approval to glatiramer acetate injection (Glatopa) 40-mg/mL for the treatment of multiple sclerosis (MS). Novartis also announced the launch of the generic drug, according to a company press release.

Glatiramer acetate injection received approval as a fully-substitutable, AP-rated generic of Copaxone 40-mg/mL, indicated as a 3-times per week treatment for relapsing forms of MS, according to the release.

The 40-mg/mL and 20-mg/mL formulations of glatiramer acetate will offer patients multiple dosing options to best meet their needs, according to the release.

Glatiramer acetate 20-mg/mL was previously launched in June 2015 and Novartis said that patients can expect the same services for the 40-mg/mL formulation.

Under Sandoz GlatopaCare, patients may qualify to avoid a co-payment, in addition to personalized injection training. The program also offers 24-hour access to nurses for medication questions and a free starter kit that includes the Glatopaject device used for both prefilled syringe doses, according to the release.

Common adverse events with glatiramer acetate injection 20mg/mL include injection site reactions and chest pain. Common adverse events with the 40mg/mL formulation were injection site reactions, Novartis reported.

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