The U.S. Food and Drug Administration (FDA) has given approval to Sandoz’s Tyruko, making it the first biosimilar to Biogen’s (NASDAQ:BIIB) Tysabri. Sandoz, a unit of Novartis (NYSE:NVS), is expected to be spun off in October.
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The approval is for the treatment of relapsing forms of multiple sclerosis (MS). The drug is also indicated for inducing and maintaining clinical response and remission in Crohn’s Disease (CD) patients.
MS, an autoimmune disease of the central nervous system (CNS), can hamper communication between the brain and other body parts and can cause acquired neurological disability.
Tysabri has been one of the most successful products in Biogen’s portfolio, contributing nearly 25% to the company’s top line in 2022. Meanwhile, Sandoz is also teaming up with CVS Health’s (NYSE:CVS) Cordavis to bring a biosimilar to AbbVie’s (NYSE:ABBV) Humira onto the market next year.
Novartis shares have climbed nearly 24.3% over the past year, and the stock has formed a double-bottom over the past four months. If the broader markets hold steady in the current macro environment, shares of the company could potentially stack up even more gains.
Novartis remains confident in the spin-off of Sandoz. An extraordinary general meeting of its shareholders is scheduled on September 15th to vote on the distribution of a dividend-in-kind and a reduction in Novartis’ share capital in connection with the spin-off.
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