First Generic Version of MS Drug Tecfidera Launching in the US

The drug company Mylan is launching a generic version of Biogen’s drug for relapsing forms of multiple sclerosis (MS), Tecfidera® (dimethyl fumarate). This is the first generic MS treatment in an oral solid-dosage form available in the United States.1

The launch of the generic version follows a U.S. district court ruling that Mylan had shown “clear and convincing evidence” that claims in Biogen’s patent for Tecfidera were “invalid for lack of written description.” Biogen is appealing the ruling.1

How will a generic drug help people with MS?

News of a generic drug for relapsing forms of MS is important because a generic version will help reduce treatment costs for both the healthcare system and people with MS. More access to affordable medications results in better symptom management and improved quality of life for more people living with MS.

How does dimethyl fumarate work?

It is not known exactly how dimethyl fumarate (DMF) works in treating MS. DMF is in a class of drugs known as Nrf2 activators. They work by decreasing inflammation and preventing nerve damage. This can help improve symptoms of MS.2

What are the side effects of dimethyl fumarate?

The most common side effects of DMF include:2

  • Flushing, redness, itching, or rash
  • Nausea, vomiting, diarrhea, stomach pain, or indigestion

Other less common side effects include:2

  • Allergic reaction (such as welts, hives, swelling of the face, lips, mouth or tongue, or difficulty breathing)
  • PML, a rare brain infection that usually leads to death or severe disability
  • Decreases in white blood cell count
  • Liver problems

These are not all the possible side effects of DMF. Talk to your doctor about what to expect or if you experience any changes that worry you.

Dimethyl fumarate in clinical trials

In a phase 3 study, DMF and a placebo were given to people with relapsing-remitting MS. Over 2 years, dimethyl fumarate greatly reduced annual relapse rates. It also reduced new lesions on the central nervous system.2

More on this topic

Another phase 3 study also compared dimethyl fumarate and placebo in people with relapsing-remitting MS. This study confirmed the findings of the first study. It also showed a decrease in disability progression in people taking DMF.2

What comes next?

The regulatory action target date, or the date when the U.S. Food and Drug Administration (FDA) is to deliver its decision about whether the generic drug application is approved, is currently set for November 16, 2020. However, Mylan is working with the FDA to move that up. The drug is will likely become available to the public within the next year or 2, after Biogen is finished with its appeal.1

Things to consider

While this is very good news for those living with relapsing forms of MS, the reality is that this generic drug might not be available for some time. If you are interested in this drug, talk with your doctor now about whether it is an option for you. Let them know you are interested, so that when the drug is available they are aware that you want to try this treatment.

For more information, read the full prescribing information about Tecfidera.

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