FDA approves biosimilar to treat multiple sclerosis

Aug. 25, 2023
The FDA granted approval of Tyruko, the first biosimilar to Tysabri (natalizumab), to Sandoz Inc.

The U.S. Food and Drug Administration approved Tyruko (natalizumab-sztn), the biosimilar to Tysabri (natalizumab) injection for the treatment of adults with relapsing forms of multiple sclerosis (MS). Tyruko, like Tysabri, is also indicated for inducing and maintaining clinical response and remission in adult patients with moderately to severely active Crohn’s Disease (CD) with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional CD therapies and inhibitors of TNF-α (tumor necrosis factor, a substance in your body that causes inflammation).

Tyruko is approved to treat the following relapsing forms of MS:

  • Clinically isolated syndrome – a single, first occurrence of MS symptoms;
  • Relapsing-remitting disease – a type of MS that occurs when patients have episodes of new neurological symptoms followed by periods of stability; and
  • Active secondary progressive disease – when, following a relapsing-remitting course, patients experience gradual disability worsening with continued relapses.

FDA release