Natalizumab-sztn is an FDA-approved monotherapy for all indications of the reference product natalizumab, including relapsing forms of multiple sclerosis and Crohn disease.

More than 2 years after its original approval, Sandoz’ natalizumab (Tyruko) biosimilar is officially available to patients with multiple sclerosis (MS) and Chron disease (CD) in the United States, the company announced. The drug, available through a Risk Evaluation and Mitigation Strategy (REMS) program, is to be used as a monotherapy for adults with these conditions.¹

Approved in August 2023 as the first biosimilar for MS, the therapy is indicated for those with clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. Natalizumab, a humanized IgG4k monoclonal antibody, was first approved by the FDA in 2004, and re-approved in 2006 under post-marketing monitoring requirements for safety concerns related to progressive multifocal leukoencephalopathy (PML).

“As the only biosimilar available to treat multiple sclerosis in the US, TYRUKO® has an important opportunity to help people with MS navigate this disease in a way that is more cost effective,” Keren Haruvi, president of Sandoz North America, said in a statement.¹ “We are proud to be expanding the reach of natalizumab, which underscores our commitment to our Purpose of pioneering access for patients.”

Natalizumab biosimilar, marketed as Tyruko, is available through a REMS program due to the increased risk of PML, especially in the presence of anti-JCV antibodies. The program advises against using Tyruko with other antineoplastic, immunosuppressive, or immunomodulatory therapies and emphasizes early PML detection and prompt discontinuation in immunocompromised patients.

Notably, Sandoz has also partnered with Labcorp to provide a validated anti-JCV antibody test at no cost to eligible patients through the Tyruko JCV Testing Program.

Similar to the original natalizumab formulation, Tyruko is contraindicated in patients who have or have had PML, as well as those who have had a hypersensitivity reaction to natalizumab products. The medication also caries warning labels for herpes infections, blindness, hepatotoxicity, and hypersensitivity reactions. In addition, natalizumab products may cause thrombocytopenia, and thus monitoring for bleeding abnormalities is required.

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