(Washington) – The United States Food and Drug administration approved Tyruko the first biosimilar to Tysabri injection for the treatment of adults with relapsing forms of multi sclerosis.
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 tumor necrosis factor.
The approval of Tyruko is based on evidence that showed there are no clinically meaningful differences between the two products in terms of safety, purity and potency.
