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FDA Approves Generic Form of Tecfidera for Relapsing MS

September 2, 2020

The U.S. Food and Drug Administration has approved the first generic version of the oral therapy Tecfidera® (dimethyl fumarate, Biogen) for the treatment of relapsing forms of MS.
  • Relapsing forms of MS include clinically isolated syndrome (an initial neurological episode), relapsing-remitting MS, and active secondary progressive MS. People with active secondary progressive MS have had progression of disability but still experience acute relapses and/or new MRI activity.
  • Dimethyl fumarate (dye-METH-il FOO-ma-rate) is a delayed release capsule taken twice per day.
  • This approval means that Mylan, the generic’s maker, provided evidence that both the 120 mg (starter dose) and 240 mg (maintenance dose) generic medications are equivalent to the brand-name Tecfidera.
  • In clinical trials, Tecfidera was shown to significantly reduce relapses and disease activity on MRIs, and in one trial it reduced progression of disability.
  • According to Mylan, this therapy is now available for prescription.
  • The announced wholesale price (WAC) equates to $85,709 per year. Out of pocket cost will vary. Mylan provides some cost relief to certain individuals with or without commercial insurance. More information here
“Generic options will increase affordability of and access to MS disease-modifying therapies, which are the cornerstone of MS management,” commented Kathy Costello, MS, ANP-BC, MSCN, Associate Vice President of Healthcare Access at the National MS Society.
Most common possible side effects of dimethyl fumarate include:
  • Flushing, redness, itching, or rash
  • Nausea, vomiting, diarrhea, stomach pain, or indigestion
Flushing and stomach problems are the most common reactions, especially at the start of therapy, and may decrease over time. Taking dimethyl fumarate delayed-release capsules with food may help reduce flushing.
Possible serious side effects include:
  • 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 counts (which can decrease the ability to fight infections). Your healthcare provider should do a blood test before you start treatment and while on therapy.
  • Liver problems. Your healthcare provider should do blood tests to check for liver function before you starting and during treatment if needed. Symptoms to look for related to liver problems during treatment include:
    • severe tiredness
    • loss of appetite
    • pain on the right side of your stomach
    • have dark or brown (tea color) urine
    • yellowing of your skin or the white part of your eyes
  • Herpes zoster infections (shingles), including central nervous system infections
  • Other serious infections 
Note on starting a disease-modifying therapy during the COVID-19 pandemic: Many experts believe it is safe to start a disease-modifying therapy (DMT), including dimethyl fumarate, during the COVID-19 pandemic. This therapy may increase your risk of infections, including COVID-19. The limited evidence available suggests that people with MS taking dimethyl fumarate do not have an increased risk of more severe COVID-19 symptoms or death.
Taking a disease-modifying therapy is currently the best way to reduce MS disease activity and future deterioration. Selecting any therapy should be done by people with MS in collaboration with their MS healthcare providers, taking into account a variety of factors, including the effectiveness of any therapy they are currently using, and weighing potential risks and benefits, costs and lifestyle factors.
Download the prescription information (information for patients is at the end of this document)
Read more about treatments for multiple sclerosis
Read more about generic medications

Tecfidera is a registered trademark of Biogen

About Multiple Sclerosis

Multiple sclerosis is an unpredictable disease of the central nervous system. Currently there is no cure. Symptoms vary from person to person and may include disabling fatigue, mobility challenges, cognitive changes, and vision issues. An estimated 1 million people live with MS in the United States. Early diagnosis and treatment are critical to minimize disability. Significant progress is being made to achieve a world free of MS.


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