FDA Tentatively Approves Dimethyl Fumarate Bioequivalent


Final approval is expected by June 20, 2020, ahead of the generic erosion following the patent expiration of Biogen’s Tecfidera.

Dr Franck Rousseau

Franck Rousseau, MD, the chief executive officer of Banner Life Sciences

Franck Rousseau, MD

Banner Life Sciences has announced that on November 16, 2018, the FDA granted tentative approval for its New Drug Application (NDA) for a novel fumarate bioequivalent alternative for dimethyl fumarate (Tecfidera, Biogen) as a treatment for relapsing multiple sclerosis (MS).1

The novel therapy is being marketed as Bafiertam. Final approval is expected by June 20, 2020, ahead of the generic erosion following the patent expiration of Tecfidera. The approving agency’s letter to Banner stated that Bafiertam meets the qualifications for the required bioequivalence, safety, efficacy, and quality standards for approval.

“We are very pleased with the FDA’s tentative approval and this important milestone brings us one step closer to providing another treatment option to patients living with relapsing-remitting multiple sclerosis,” said Franck Rousseau, MD, the chief executive officer of Banner Life Sciences, in a statement. “In anticipation of final approval, we will establish our commercial vehicle, continue developing the clinical profile of Bafiertam and refine our strategic positioning for this important drug.”

This news followed the dismissal of a lawsuit against Banner by Biogen, in which Biogen had claimed the Banner product would infringe on its patents—7,320,999 and 8,399,514—for Tecfidera. The dismissal of the suit granted Banner freedom to operate after the expiration of the 7,619,001 patent.

The Banner product has been shown to activate the nuclear factor (erythroid-derived 2)-like 2 (Nrf2) pathway, although its precise mechanism of action has not been fully clarified in the literature. in two separate studies, the Tecfidera was shown to reduce the risk of MS relapse by 49% and 34%, and to reduce the number of relapses by 53% and 44%, compared to placebo. 2

The active ingredient in the Bafiertam product is monomethyl fumarate, which is immediately capable of crossing the blood-brain barrier, unlike its prodrug Tecfidera, which is converted to monomethyl fumarate from dimethyl fumarate once in the body.

Biogen’s Tecfidera has also been shown in trials to impact the immune system, reducing blood lymphocytes particularly well in pro-inflammatory subgroups, as well as blocking the production of pro-inflammatory cytokines.

As an oral treatment for MS, dimethyl fumarate has become popular among patients. Previously, Darin Okuda, MD, a professor of neurology and neurotherapeutics, director of the Multiple Sclerosis and Neuroimmunology Imaging Program, director of Neuroinnovation, and deputy director of the Multiple Sclerosis Program and Clinical Center at UT Southwestern Medical Center, told NeurologyLive that it is one of a few oral that has high usage.

“[Orals like dimethyl fumarate] have really served as a new path for administration. People are migrating away from the classic parentally administrated treatments,” he said. “They were all given either intramuscularly or subcutaneously, back in the day, but with the advent of treatments that are available to patients in oral form, there has been some transition to those types of agents.”


1. Banner Receives FDA Tentative Approval for BAFIERTAM for the Treatment of Relapsing Forms of Multiple Sclerosis [press release]. High Point, NC: Banner Life Sciences LLC; Published January 2, 2019. businesswire.com/news/home/20190102005088/en/Banner-Receives-FDA-Tentative-Approval-BAFIERTAM-Treatment. Accessed January 8, 2019.

2. Tecfidera prescribing information. Tecfidera website. Updated December 2017. tecfidera.com/content/dam/commercial/tecfidera/pat/en_us/pdf/full-prescribing-info.pdf. Accessed January 8, 2019.

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