New Copaxone Generic Now Approved: Glatopa May Reduce Treatment Costs

Roni Shye
Roni Shye, PharmD BCGP BCACP, is a licensed pharmacist in the states of Florida, Ohio, and Pennsylvania.
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Multiple sclerosis (MS) is a debilitating autoimmune disease that currently does not have a cure. It affects around 400,000 people in the United States alone, with symptoms presenting most often between 20 and 40 years of age.

Copaxone (glatiramer acetate), one of the most popular treatments for multiple sclerosis, has recently received generic FDA approval under the name Glatopa.

The FDA approval of Glatopa is a big deal for patients being treated for MS, especially since medication costs for this condition are nearing $60,000 a year.

Glatopa will be the first generic multiple sclerosis product approved for use in the United States. It is expected to offer those with MS a more affordable yet high-quality option.

What is this medication used for?
Copaxone (glatiramer acetate) and Glatopa are indicated for the treatment of relapsing forms of multiple sclerosis.

What is multiple sclerosis?

Multiple sclerosis, also known as MS, is an autoimmune disease—this means that your body begins to attack itself. The cause is unknown.

In MS your immune system attacks the protective covering of your nerves, which disrupts communication to your brain as well as other parts of your body.

For more information from The Mayo Clinic on MS click here.

When will the new generic Glatopa be available?
Glatopa, at this time, does not have a set release date.

When did the FDA approve Glatopa?
Glatopa was approved by the FDA on April 16, 2015.

In what dosage form and strength will Glatopa be available?
Glatopa (glatiramer acetate) will only be available as an 20 mg/mL injection, for use once daily.

Copaxone is also available in a 40mg/mL injection for use three times weekly, however, this strength has not received generic approval by the FDA yet.

What are the most common side effects?

Some of the most common side effects of Glatopa and Copaxone include injection side reactions, redness, rash, shortness of breath, and chest pain.

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