Tyruko, first Tysabri biosimilar, cleared in US to treat relapsing MS

The U.S. Food and Drug Administration (FDA) has approved Tyruko (natalizumab-sztn) as the first biosimilar of Tysabri to treat adults with relapsing forms of multiple sclerosis (MS).

The decision also marks the first approval of any biosimilar for MS in the country, according to the regulatory agency.

Much like a generic for lab-made medications, a biosimilar is considered to have no clinically meaningful differences from its brand-name biological alternative. This means it has the same mechanism, pharmacological properties, safety, and efficacy profile as the original medication — but it usually is sold at a lower price.

Tyruko was approved for all indications covered by the brand-name medicine: clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive MS. It’s also been approved for certain adults with Crohn’s disease.

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Like Tysabri, Tyruko is a once monthly infusion therapy for relapsing MS

“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 … to increase access to safe, effective and high-quality medications at potentially lower cost,” Sarah Yim, MD, director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research, said in a FDA press release.

Tyruko was originally developed by Polpharma Biologics, which entered into a commercialization agreement in 2019 with Sandoz, a subsidiary of Novartis specializing in biosimilar medications. Polpharma will continue to manufacture and supply Tyruko, and Sandoz will market it.

“Of the nearly one million people in the US living with multiple sclerosis, hundreds of thousands experience disease relapse,” Keren Haruvi, president of Sandoz for North America, said in a company press release. “Tyruko has the potential to extend the reach of natalizumab treatment for these patients, increase healthcare savings and fuel innovation through competition in the market.”

Approval of this biosimilar is under consideration in Europe and a decision is expected soon, Polpharma said in a separate press release.

Approved in 2004, Biogen‘s Tysabri is an antibody-based therapy that works to prevent immune cells implicated in MS from accessing the brain and spinal cord, easing disease-driving inflammation.

In the U.S., the therapy is given as an intravenous (into-the-vein) infusion at a dose of 300 mg once every four weeks. Tyruko has the same dosing and administration schedule as Tysabri.

Tyruko showed similar safety and efficacy to Tysabri in MS clinical trials

To earn approval as a biosimilar, a medication must meet FDA standards and show that it doesn’t differ meaningfully from the reference medication.

Sandoz reported providing the FDA with a robust data package, including results of Phase 1 and Phase 3 trials demonstrating the two medications have similar safety and efficacy, and they elicit similar immune system responses in patients.

“The approval of Tyruko, the first FDA-approved biosimilar disease-modifying treatment for people with relapsing forms of MS, is a milestone,” said Bari Talente, executive vice president for advocacy and healthcare access at the National MS Society.

“Biosimilars are an important treatment option because they have no clinically meaningful differences from their reference medicines. Prescribing them can increase accessibility to affordable medications, improve adherence and help contain healthcare costs,” Talente added.

Much like Tysabri, Tyruko will only be available through a restricted distribution program, called the Tyruko Risk Evaluation and Mitigation Strategy (REMS) program. This is because natalizumab-based medications are associated with a risk of progressive multifocal leukoencephalopathy (PML), a rare but life-threatening brain infection.

The REMS program requires program certification for healthcare professionals who prescribe these medications, and the pharmacies and infusion centers that dispense them. Patients must be evaluated three and six months after the first infusion, every six months during treatment, as well as immediately and six months after stopping treatment.

Common side effects of Tysabri and Tyruko in MS include headache, fatigue, joint pain, urinary tract infection, respiratory tract and vaginal infections, stomach flu and abdominal discomfort, depression, pain in extremities, diarrhea, and rash.