The first biosimilar drug for treating multiple sclerosis (MS) could become available for patients in the future, according to a press release made by the US Food and Drug Administration (FDA).

“Biosimilar medications offer additional effective treatment options that have the potential to increase access for people living with relapsing forms of multiple sclerosis,” said Paul Lee, MD, PhD, the director of the division of neurology in the FDA’s Center for Drug Evaluation and Research.

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The FDA granted its approval to natalizumab-sztn, the first biosimilar to natalizumab injection. This milestone marks a significant advancement in treatment options for adults with relapsing forms of MS and those with moderately to severely active Crohn’s disease with evidence of inflammation.

Natalizumab-sztn mirrors natalizumab indications, including the induction and maintenance of clinical response and remission in adult patients suffering from moderately to severely active Crohn’s Disease who have had insufficient responses to or are intolerant of conventional therapies and tumor necrosis factor-alpha inhibitors.

This novel drug has 3 different indications for patients with MS. The first 1 is a clinically isolated syndrome characterized by a 1-time episode of symptoms secondary to MS. The second indication is the diagnosis of a relapsing-remitting disease, described as various episodes of new clinical presentation in between periods of symptom stabilization. Finally, the third indication is the presence of active secondary progressive disease, in which case patients exhibit a relapsing-remitting course followed by gradual disability.

Biosimilars are highly similar to and exhibit no clinically meaningful differences from an FDA-approved biological product, which is the reference product. Natalizumab-sztn’s approval is based on extensive evidence confirming its similarity to natalizumab in terms of purity, safety, and potency.

Natalizumab-sztn does carry a boxed warning due to the risk of progressive multifocal leukoencephalopathy (PML), a viral brain infection. Hence, they “are available only through a restricted drug distribution program under a risk evaluation and mitigation strategy (REMS),” the authors noted. This means that certified healthcare professionals and pharmacies are required to distribute and enroll patients in the REMS program. The REMS mandates regular patient evaluations and monitoring due to potential risks, including PML.


FDA approves first biosimilar to treat multiple sclerosis. FDA; August 24, 2023.