Tyruko, the first biosimilar to treat multiple sclerosis, is now available

Sandoz’s Tyruko (natalizumab-sztn) is now available for prescription in the United States, according to today’s news release. Tyruko is the first FDA-approved biosimilar of Tysabri (natalizumab), used to treat adult patients with relapsing multiple sclerosis. It is also approved to treat patients with moderate to severe Crohn’s disease.

The FDA approved Tyruko in August 2023, and it was set to launch in 2024, pending a second FDA approval of a test to detect anti-JVC antibodies. Natalizumab products carry a risk of progressive multifocal leukoencephalopathy (PML), a rare brain infection caused by the John Cunningham virus that can occur in patients with an immune system weakened by immunosuppressant drugs.

Sandoz has partnered with Labcorp to develop a test to detect anti-JCV antibodies, which can lead to the development of PML. This testing will be available to eligible patients at no extra cost.

Natalizumab products are only available through a restricted drug distribution program, due to the increased risk of PML. Patients taking Tyruko must be evaluated by their provider every three to six months after the first infusion, every six months during treatment and then six months after discontinuing treatment.

Multiple sclerosis is a chronic autoimmune disease that affects more than 2.9 million people worldwide. Relapsing forms of MS include relapsing-remitting MS, which is the most common type of MS, accounting for approximately 85% of all diagnoses.

Crohn’s disease is a chronic bowel disease that causes inflammation along the digestive tract. It impacts approximately half a million Americans. Symptoms can include persistent diarrhea, rectal bleeding and abdominal cramping.

The approval was made using data from the phase 3 clinical trial that showed the biosimilar product was equivalent in efficacy, safety and immunogenicity to natalizumab.

Tyruko is an anti-α4 integrin monoclonal antibody, administered in a single dose vial of 300 mg solution that must be diluted before intravenous infusion. In Crohn’s disease patients, Tyruko should not be used in combination with TNF-α inhibitors or immunosuppressants.

Adverse reactions occurring in at least 10% of patients for both indications include headache, fatigue and upper respiratory tract infections. Additional risk factors include herpes infections, hepatoxicity and thrombocytopenia.

Crohn’s disease and MS represent a high economic burden for the economy and the individual patient.

The annual economic burden of MS patients in the United States is approximately $85 billion. The average individual cost of MS per patient is approximately $88,500 annually, the biggest driver being medication, which can cost a patient between $57,202 and $92,719 per year.

Crohn’s disease is associated with $3.5 billion in total national costs, and the individual patient burden is estimated to be $13,446.

“For people living with multiple sclerosis, cost and access to care remain significant barriers,” Leslie Ritter, vice president of Healthcare Access for the National MS Society, said in a separate news release. “The availability of a biosimilar is an important step forward in making medications more affordable.”