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News

Sandoz Launches Tyruko® (natalizumab-sztn), First U.S. Biosimilar to Tysabri®

by Leah Watson; Robert S. Schwartz, Ph.D.
November 20, 2025

On November 17, 2025, Sandoz and Polpharma announced the U.S. launch of Tyruko® (natalizumab-sztn), the first and only FDA-approved biosimilar to Biogen’s Tysabri® (natalizumab) and the first biosimilar available to treat multiple sclerosis (MS) in the United States.

Tyruko® is approved as a monotherapy for all indications covered by reference medicine Tysabri®, including relapsing forms of MS and Crohn’s disease in adults.

Sandoz and Polpharma have collaborated on biosimilar natalizumab since a 2019 global commercialization agreement, under which Polpharma developed, manufactured, and supplies the drug substance, and Sandoz holds exclusive global rights to commercialize and distribute the product.

FY24 U.S. sales for Tysabri® were approximately $920 million.

For more information on this and other biosimilars and biologic patent disputes, please visit BiologicsHQ.com.

 

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The authors would like to thank April Breyer Menon for her contributions to this article.

    Methodology

    Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.

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