FDA approves generic version of Vumerity for relapsing MS

Zydus Lifesciences received final approval from the U.S. Food and Drug Administration (FDA) to market a generic version of Vumerity (diroximel fumarate) for adults with relapsing forms of multiple sclerosis (MS) and other conditions.

The drug will be sold as 231 mg delayed-release capsules, produced at Zydus’s manufacturing facility in Ahmedabad, India, according to a company press release.

It will be available for the same indications as the brand-name medication: clinically isolated syndrome (CIS), relapsing-remitting disease (RRMS), and active secondary progressive MS (SPMS).

Vumerity, marketed by Biogen, is an oral disease-modifying therapy that works by reducing inflammation and protecting nerve cells from damage, helping to prevent relapses, reduce MRI disease activity, and delay disability progression in relapsing forms of MS.

Like the brand-name medication, the Zydus generic contains diroximel fumarate, an inactive molecule that is converted into its active form, monomethyl fumarate (MMF), once inside the body. MMF is also the active ingredient in Biogen’s older therapy Tecfidera (dimethyl fumarate). However, Vumerity has been shown to cause fewer gastrointestinal side effects than Tecfidera, mainly due to differences in their chemical structure and metabolism.

Generics are medications that contain the same active ingredient as a reference product and must match the original in terms of strength, dosage, and route of administration. They’re also required to deliver the same amount of active ingredient into the bloodstream and demonstrate comparable safety and efficacy.

Because generic manufacturers can rely on the original drug’s clinical data instead of conducting extensive new trials, these medicines are typically less expensive to develop and are sold at lower prices. As a result, they can broaden access for people who may not be able to afford the brand-name therapy.

Zydus’ generic received tentative approval from the FDA in July 2024, meaning the product met all quality, safety, and efficacy standards, but could not yet be marketed because of legal barriers. A lawsuit against the company over the treatment was settled earlier this year, according to Bloomberg Law.