FDA Clears Generic Glatiramer Acetate Injection for Relapsing Multiple Sclerosis


The injection therapy now has an indication for use in either 40 mg/mL or 20 mg/mL doses, with the lower dose having been approved in June 2015.

Richard Francis

The US Food and Drug Administration (FDA) granted approval to glatiramer acetate injection (Glatopa, Sandoz) 40 mg/mL for the treatment of relapsing forms of multiple sclerosis (MS).

A thrice-weekly therapy, injectable glatiramer acetate is an AP-rated (therapeutically equivalent), fully substitutable generic variety of Teva Pharmaceuticals’ glatiramer acetate injection, Copaxone. It was developed through a collaborative agreement between Sandoz and Momenta Pharmaceuticals.

The injection therapy now has an indication for use in either 40 mg/mL or 20 mg/mL doses, with the lower quantity having been granted approval in June 2015.

"The approval and launch of Glatopa 40 mg/mL reinforces our leadership in delivering complex, differentiated generic products,” Richard Francis, the CEO of Sandoz, said in a statement.1 “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.”

With its approval, the Sandoz product adds to the available generic options for this indication, which previously only included Mylan’s duo of generics, which were approved in October 2017. The original Teva product they are modeled after, Copaxone, was the most prescribed treatment for relapsing forms of MS in the past few years, with sales eclipsing $4 billion. Almost half a million US patients have MS, with 85% suffering relapses.

The safety data was consistent for the new generic. Compared to placebo, the most common adverse events (AEs) with glatiramer acetate injection 20mg/mL patients were erythema (43% vs 10%); vasodilatation (20% vs 5%); rash (19% vs 11%); dyspnea (14% vs 4%); and chest pain (13% vs 6%). The most common AE with glatiramer acetate injection 40mg/mL vs placebo was erythema (22% vs 2%).

Compared with placebo, approximately 12% more of glatiramer acetate injection 20mg/mL patients and approximately 2% more of glatiramer acetate injection 40mg/mL patients experienced ≥2 symptoms that occurred within minutes of the injection. Those included flushing, chest pain, palpitations, tachycardia, anxiety, dyspnea, throat constriction, and urticaria.

These symptoms “generally have their onset several months after the initiation of treatment, although they may occur earlier, and a given patient may experience 1 or several episodes of these symptoms,” according to Sandoz.

Transient chest pain was noted in 7% more glatiramer acetate injection 20mg/mL patients than those on placebo, and approximately 1% more of glatiramer acetate injection 40mg/mL patients. It was noted that the relationship of this chest pain to an injection was not always understood.

Sandoz said it will offer a $0 co-pay support program, donned Sandoz GlatopaCare, for patients that qualify. To aid in patient confidence with injection administration, the program will offer personalized injection training, in addition to 24-hour access to nurses for glatiramer acetate-related questions and a free ‘starter kit,’ including an injection device that was designed to with prefilled syringes for both dosing options.


1. Sandoz announces US FDA approval and launch of Glatopa® 40 mg/mL three times-a-week generic option for relapsing forms of multiple sclerosis [press release]. Holzkirchen, Germany: Sandoz; February 13, 2018. sandoz.com/news/media-releases/sandoz-announces-us-fda-approval-and-launch-glatopar-40-mgml-three-times-week. Accessed February 13, 2018.

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