FDA Approves Groundbreaking Biosimilar for Multiple Sclerosis Treatment

The FDA has approved Tyruko, the first biosimilar to Tysabri, for the treatment of adults with relapsing forms of multiple sclerosis (MS). Tyruko is also indicated for treating moderately to severely active Crohn's Disease. Biosimilars are highly similar to already approved biological products and offer additional treatment options for patients. The approval of Tyruko is based on evidence showing no clinically meaningful differences in safety and effectiveness compared to Tysabri. However, both medications carry a boxed warning about the increased risk of progressive multifocal leukoencephalopathy (PML), a viral infection of the brain.