First Biosimilar to Treat Relapsing Multiple Sclerosis Approved by FDA

Tyruko (natalizumab-sztn; Sandoz, Basel, Switzerland), a biosimilar of Tysabri (natalizumab; Biogen, Cambridge, MA) developed by Polpharma Biologics (Warsaw, Poland), has received Food and Drug Administration (FDA) approval to treat adults with relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), and active secondary progressive MS (SPMS). Tyruko, an integrin receptor antagonist, is administered as a 300 mg intravenous (IV) infusion once every 4 weeks.

The FDA approval was based on data showing that Tyruko had no meaningful differences compared to Tysabri in terms of safety and effectiveness. Results of the phase 3 clinical trial ANTELOPE (NCT04115488), published in JAMA Neurology, compared the safety and efficacy of Tyruko and Tysabri in treating RRMS. The study included 264 adult participants diagnosed with RRMS who were randomized to receive either Tyruko or Tysabri over a period of 44 weeks, with rerandomization at week 24. The study met its primary endpoint, with a similar cumulative number of new active lesions reported in both treatment groups. There were no major differences in secondary endpoints for the 2 medications, including disability.

"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,” said Sarah Yim, MD, Director of the Office of Therapeutic Biologics and Biosimilars at the FDA.

The prescribing information for Tyruko and Tysabri contains a boxed warning for increased risk of progressive multifocal leukoencephalopathy (PML), a viral infection of the brain that can cause death or disability. The boxed warning provides information about risk factors, signs, and symptoms of PML. Tyruko is available only through a restricted distribution program under a Risk Evaluation and Mitigation Strategy (REMS).