On November 17, Tyruko (reference product, Tysabri) became available to treat relapsing forms of multiple sclerosis (MS), in addition to Crohn’s disease. This agent is the first biosimilar to treat MS in the United States.
Manufactured by Polpharma Biologics and commercialized by Sandoz, Tyruko was approved by the FDA in August 2023, but its launch was delayed by FDA’s certification of a test for the JC virus, which must be administered before infusing natalizumab. Sandoz has partnered with Labcorp to administer the JC virus test (which is paid for by Sandoz).
In a press release from Sandoz, Leslie Ritter, Vice President of Healthcare Access for the National MS Society, stated, “For people living with MS, cost and access to care remain significant barriers. The availability of a biosimilar is an important step forward in making medications more affordable.”
Tyruko is available in Europe, and Sandoz has the exclusive license to market the product globally. Biogen reported US net 2024 sales of Tysabri at $920 million, an 8% decrease from the previous year. Biogen’s Tysabri revenues in the rest of the world decreased by 10%, which they attributed to growing biosimilar marketshare.
Natalizumab has about 5% marketshare of the MS category, partly the result of its black box warning for the risk of progressive multifocal leukoencephalopathy, a potentially fatal, brain infection caused by the JC virus. The test for the JC virus seeks the presence of antibodies to the virus. The MS category is dominated by Ocrevus, which has generated more interest in biosimilar development, but will not come off patent until late 2028.
Keren Haruvi, President of Sandoz North America, said, “As the only biosimilar available to treat MS in the US, Tyruko has an important opportunity to help people with MS navigate this disease in a way that is more cost effective. We are proud to be expanding the reach of natalizumab, which underscores our commitment to our purpose of pioneering access for patients.”
No other biosimilar manufacturer has disclosed a biosimilar candidate for natalizumab. Limited competition could restrict cost savings on the agent. A request for Tyfuko pricing information from Sandoz was not answered at the time of publication.
As we reported last month, Tyruko will be the first biosimilar therapy for neurology practices. It will be interesting to see how quickly (or how slowly) they gain comfort in prescribing a natalizumab biosimilar.
