News Report · Neurology

FDA Approves Tyruko for MS: First Biosimilar to Natalizumab

June 11, 2026

Clinical Perspective

Tyruko is indicated for adults with relapsing forms of MS, providing a new treatment option for patients who may not have responded adequately to existing therapies. The approval supports the use of biosimilars in increasing access to effective treatment, potentially improving patient outcomes. How will the introduction of Tyruko impact the treatment landscape for MS patients?

Dr. Vikram Patel · Neurology

The FDA approved Tyruko (natalizumab-sztn) for relapsing forms of multiple sclerosis (MS) on August 24, 2023, based on evidence showing comparable efficacy and safety to the reference product, Tysabri (natalizumab) ^[9].

Clinical Context

Multiple sclerosis (MS) is a chronic, inflammatory, autoimmune disease that affects the central nervous system, leading to significant neurological disability. It is estimated that over 1.8 million people are affected by MS worldwide, with a higher prevalence in young adults and females ^[1]. Current treatment options aim to reduce the frequency of relapses and slow disease progression; however, many patients may experience inadequate responses to existing therapies. The recent approval of Tyruko provides a new biosimilar option that could enhance treatment accessibility for patients with relapsing forms of MS, addressing the need for effective disease-modifying therapies in this population.

Key Findings

The FDA approval of Tyruko was based on studies demonstrating that it has no clinically meaningful differences in safety, purity, and potency compared to Tysabri ^[9].
Tyruko is indicated for the treatment of clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults with MS ^[9].
The approval is expected to increase treatment options for patients with relapsing forms of MS, potentially improving access to effective therapies ^[9].
Event rates for Tyruko are expected to be similar to those seen with Tysabri, given the biosimilar's design and formulation ^[9].
The primary endpoint for the studies leading to approval was the comparison of efficacy and safety profiles between Tyruko and Tysabri in treating relapsing forms of MS ^[9].
Tyruko is administered via subcutaneous injection, following the same dosing regimen as Tysabri ^[9].

Safety & Tolerability

Headache reported with Tyruko — exact frequency not available in public source summary ^[9].
Fatigue reported — exact frequency not available in public source summary ^[9].
Nausea reported with Tyruko ^[9].
Injection site reactions reported — exact frequency not available in public source summary ^[9].
Risk of progressive multifocal leukoencephalopathy (PML) — advise patients of the potential risks associated with treatment ^[9].
Complete adverse event profile available in the full prescribing information for Tyruko.

Study Design

The approval of Tyruko was based on clinical studies that evaluated its efficacy and safety compared to Tysabri in patients with relapsing forms of MS. These studies involved a diverse population and focused on the primary endpoint of assessing the incidence of relapses and progression of disability over a specified follow-up duration. Limitations of the studies include the need for further long-term data on the safety profile of Tyruko in real-world settings. Ongoing studies will continue to monitor the drug's performance post-approval.

FDA Approves Tyruko for MS: First Biosimilar to Natalizumab

FDA Approves Tyruko for MS: First Biosimilar to Natalizumab

Clinical Perspective

Clinical Context

Key Findings

Safety & Tolerability

Study Design

References

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