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Practical NeurologyFirst Biosimilar to Treat Relapsing Multiple Sclerosis Approved by FDA

FDA Approves Tyruko, a Biosimilar to Tysabri, for Relapsing Forms of Multiple Sclerosis

The FDA has given the green light to Tyruko, a biosimilar of Tysabri, for the treatment of adults with various relapsing forms of multiple sclerosis (MS). Developed by Polpharma Biologics and marketed by Sandoz, Tyruko has shown no meaningful differences in safety and efficacy compared to its reference product, Tysabri, in phase 3 clinical trials.

HCN Medical Memo
The FDA approval of Tyruko offers a new, potentially more affordable treatment option that has demonstrated safety and efficacy comparable to Tysabri. This approval could pave the way for increased competition in the biological products marketplace, potentially lowering costs and expanding patient access to effective MS treatments.

Key Points:
  • Tyruko is approved for treating adults with clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), and active secondary progressive MS (SPMS).
  • The biosimilar is administered as a 300 mg intravenous (IV) infusion once every 4 weeks.
  • Phase 3 clinical trial ANTELOPE showed no major differences between Tyruko and Tysabri in treating RRMS, meeting its primary endpoint.
  • Sarah Yim, MD, Director of the Office of Therapeutic Biologics and Biosimilars at the FDA, emphasized the approval’s role in increasing access to safe and effective medications at potentially lower costs.

“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 ultimately empowers patients by helping 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, FDA

Additional Points:
  • Both Tyruko and Tysabri come with a boxed warning for increased risk of progressive multifocal leukoencephalopathy (PML), a potentially fatal brain infection.
  • Tyruko is available only through a restricted distribution program under a Risk Evaluation and Mitigation Strategy (REMS).

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