FDA Approves Generic Version of Tecfidera®, Taken Orally for MS

Reviewed by MSAA Chief Medical Officer Barry A. Hendin, MD

On August 17, 2020, the United States Food and Drug Administration (FDA) awarded early approval of Mylan’s generic version of Biogen’s Tecfidera® (dimethyl fumarate), an oral medication approved in 2013 for relapsing forms of MS in adults. Mylan announced the launch of this generic medication on August 19, 2020, noting that this is the first generic of any MS oral treatment available to individuals in the United States. In late 2019, the FDA approved three generic versions of Gilenya® (fingolimod) oral capsules for the treatment of relapsing forms of multiple sclerosis (MS), but these are not yet commercially available.

Generic treatments have the same active ingredients and carry the same benefits and risks of the initially approved (brand-name) medication. Inactive ingredients can differ with generic medications, and generic treatments are not required to conduct the same degree of rigorous clinical trials prior to approval. As a result, generic medications are normally offered at a lower cost to the patient.

Tecfidera was approved by the FDA in March 2013 as a first-line therapy for the long-term treatment of relapsing forms of MS in adults. This now includes clinically isolated syndrome, relapsing-remitting disease, and active secondary-progressive disease. Tecfidera’s starting dose is a delayed-release 120-mg capsule taken twice daily for seven days, followed by a maintenance dose of a delayed-release 240-mg capsule taken twice daily. Mylan’s generic version is given in the same dosage and both 120-mg and 240-mg delayed-release capsules are available.

Clinical trials with Tecfidera showed a reduction in relapse rate, a delay in progression of physical disability, and a slowing in the development of brain lesions, as compared to placebo. The most commonly reported side effects are flushing and gastrointestinal events, occurring more often at the beginning of treatment, and decreasing in frequency after the first one to two months on this medication.

According to MSAA’s Chief Medical Officer Dr. Barry A. Hendin, “We are witnessing an increasing role of generics in disease-modifying therapies for MS. We always welcome more options for the MS community and hope that these generic agents may also lower the cost of long-term treatments for MS. While having more affordable therapies is vitally important, those taking generic treatments may miss the high level of patient support provided by makers of the brand-name medications.”

Tecfidera’s original patent was set to expire in 2028, but a West Virginia federal court found the patent to be lacking in certain written descriptions and deemed the patent invalid, allowing generics to be marketed. Biogen is appealing this decision.

Mylan’s generic version of Tecfidera has been shipped to pharmacies and is available by prescription. Anyone with questions or in need of help with locating this medication may call Mylan’s customer service number: (800) 796-9526.

For general information or to speak with a trained Client Services Specialist, please call MSAA’s Helpline at (800) 532-7667, extension 154. Questions to MSAA’s Client Services department may also be emailed to MSquestions@mymsaa.org.

Written by Susan Wells Courtney, MSAA Senior Writer
Reviewed by Dr. Barry A. Hendin, MSAA Chief Medical Officer