FDA Approves Generic of Tecfidera for Adults With Relapsing MS

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by Joana Carvalho |

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The U.S. Food and Drug Administration (FDA) has approved Cipla’s dimethyl fumarate capsules, a generic version of Biogen’s Tecfidera, to treat adults with relapsing forms of multiple sclerosis (MS), the company announced in a press release.

This generic is packaged as 120 mg or 240 mg delayed release capsules of dimethyl fumarate, or as a 120/240 mg mixed capsule starter pack. Once prescribed, it is available “for shipping immediately” to adults in the U.S. with clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), and active secondary progressive MS (SPMS), Cipla stated.

Approval followed submission of an Abbreviated New Drug Application (ANDA), a type of classification for generic medication up for FDA consideration. Treatments approved via an ANDA are equally safe and effective as the brand-name product (in this case, Tecfidera), and are often lower cost alternatives.

Tecfidera was approved as a first-line oral therapy for adults in the U.S. in 2013. Europe, followed by Canada, Australia, and Switzerland, gave approvals for similar relapsing MS indications in 2014.

The therapy is thought to lower inflammation and oxidative stress — cell damage caused by high levels of oxygen reactive species — in the central nervous system, which includes the brain and spinal cord. It works by interfering with a signaling pathway involving Nrf2, a protein that controls the activity of genes that regulate oxidative stress.

Clinical trials of Tecfidera demonstrated that, compared to a placebo, the therapy can significantly reduce relapse rates in MS patients and increase the time to disease progression.

Cipla’s generic version of dimethyl fumarate is considered an AB-generic to Biogen’s Tecfidera, meaning that both products have been shown to be equivalent from a biological and biochemical standpoint in preclinical studies. The AB-rating is a common designation among generic medications.

Cipla, which is based in Mumbai, India, announced it is opening a co-pay assistance program for patients needing access to this generic version of Tecfidera.

The company was founded in 1935 with a goal of making quality and affordable medicines for people worldwide. Its other available U.S. generics include icatibant, a bioequivalent to Firazyr, an injection treatment for adults with acute attacks of hereditary angioedema (HAE) that is marketed by Shire, now part of Takeda.

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