August 28, 2023- The U.S. Food and Drug Administration approved Tyruko (natalizumab-sztn), the first 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).
Biological products include medications for treating many serious illnesses and chronic health conditions, including MS. A biosimilar is a biological product that is highly similar to, and has no clinically meaningful differences from, a biological product already approved by the FDA (also called the reference product). This means patients can expect the same safety and effectiveness from the biosimilar as they would the reference product.
All biological products are approved only after they meet the FDA’s rigorous approval standards. The approval of Tyruko, a biosimilar to Tysabri (natalizumab), is based on evidence that showed there are no clinically meaningful differences between the two products in terms of safety, purity and potency (i.e., safety and effectiveness).