FDA Approves Biosimilar Tyruko for Multiple Sclerosis, Crohn Disease

The Food and Drug Administration (FDA) has approved Tyruko^® (natalizumab-sztn), a biosimilar to Tysabri (natalizumab).

Tyruko is indicated as monotherapy for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. This is the first biosimilar product indicated for treating relapsing forms of MS.

The approval was based on a robust data package that included phase I and phase 3 clinical studies. Findings from the phase 3 Antelope study (ClinicalTrials.gov Identifier: NCT04115488) in RRMS patients showed that the biosimilar product was equivalent in efficacy, safety and immunogenicity to the reference product.

“Today’s approval of the first biosimilar product indicated to treat relapsing forms of multiple sclerosis furthers the FDA’s longstanding commitment to support a competitive marketplace for biological products and ultimately empowers patients by helping to increase access to safe, effective and high-quality medications at potentially lower cost,” said Sarah Yim, M, director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research.

Tyruko is also approved for inducing and maintaining clinical response and remission in adult patients with moderately to severely active Crohn disease (CD) with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional CD therapies and inhibitors of TNF-α.

Like the reference product, the prescribing information for Tyruko includes a Boxed Warning regarding the risk of progressive multifocal leukoencephalopathy (PML). Because of the risk of PML, Tyruko is only available through a restricted distribution program called the Tyruko REMS Program.  When initiating and continuing treatment, clinicians should consider whether the expected benefit of Tyruko is sufficient to offset the risk of PML.

Tyruko is supplied as a 300mg/15mL solution in a single-dose vial for dilution prior to infusion.