New Tysabri biosimilar Tyruko now on market for relapsing MS
Therapy arrives with same indications, dosing, and REMS safeguards
Tyruko (natalizumab-sztn) is now commercially available in the U.S. as the first and only approved biosimilar to Tysabri for adults with relapsing forms of multiple sclerosis (MS).
The therapy received approval from the U.S. Food and Drug Administration (FDA) in 2023 for all indications covered by the brand-name medicine, including clinically isolated syndrome, relapsing-remitting MS (RRMS), and active secondary progressive MS. It’s also approved for certain adults with Crohn’s disease.
A biosimilar is a biological therapy shown to have no clinically meaningful differences from its reference medication in terms of mechanism of action, pharmacological properties, safety, and efficacy. While highly similar to the brand-name medication, it is often offered at a lower cost to help improve patient access.
Tyruko was originally developed by Polpharma Biologics. In 2019, Sandoz, a company that focuses on biosimilar and generic medicines, acquired the global marketing and distribution rights.
“As the only biosimilar available to treat multiple sclerosis in the U.S., Tyruko has an important opportunity to help people with MS navigate this disease in a way that is more cost effective,” Keren Haruvi, president at Sandoz North America, said in a company press release. “We are proud to be expanding the reach of natalizumab, which underscores our commitment to our Purpose of pioneering access for patients.”
How Tysabri and Tyruko work in MS
MS occurs when the immune system mistakenly attacks myelin, the protective coating around nerve fibers that’s essential for proper nerve communication. This causes inflammation and nerve damage, which lead to the range of MS symptoms.
Tysabri, developed by Biogen and approved in 2004, is an antibody-based therapy that works by blocking a key protein used by immune cells to cross blood vessel walls, thereby preventing them from entering the brain and spinal cord and driving inflammation.
In the U.S., it is given as a 300 mg intravenous (into-the-vein) infusion every four weeks. Clinical and real-world data have shown it can significantly reduce disease activity and help delay disability progression in relapsing forms of MS.
Tyruko follows the same dosing and administration schedule as Tysabri.
“For people living with multiple sclerosis, cost and access to care remain significant barriers,” said Leslie Ritter, vice president of healthcare access for the National MS Society. “The availability of a biosimilar is an important step forward in making medications more affordable.”
Because Tyruko, like Tysabri, carries a risk of progressive multifocal leukoencephalopathy (PML) — a rare but potentially life-threatening brain infection — it is available only through a restricted program called Risk Evaluation and Mitigation Strategy (REMS).
The REMS program includes steps to ensure safe use, such as checking a person’s PML risk before starting treatment, ongoing monitoring, and stopping therapy if PML is suspected.
Healthcare providers, pharmacies, and infusion centers must be certified to prescribe, dispense, and administer Tyruko. Patients must be enrolled in the program before starting treatment.
Outside the U.S., Tyruko is approved in the European Union for adults with highly active RRMS and is now available in 14 European countries, according to the company.
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