FDA approves Sandoz’s natalizumab biosimilar, likely putting a damper on Biogen’s Tysabri sales

On the back of Sandoz’s FDA approval for the first-ever natalizumab biosimilar, branded as Tyruko, Biogen now has a formidable multiple sclerosis market competitor for its top-selling monoclonal antibody Tysabri.

Keren Haruvi

“Tyruko has the potential to extend the reach of natalizumab treatment for these patients, increase healthcare savings and fuel innovation through competition in the market,” Sandoz North America president Keren Haruvi said in a press release.

The average cost for Tysabri in multiple sclerosis is $117,000 in the first year and then $106,000 the next year. The biosimilar’s price is yet to be released.

The FDA’s approval for the biosimilar also covers Crohn’s disease in adults, for which the originator drug was approved in 2008. Tysabri, an anti-α4 integrin monoclonal antibody, was approved for MS four years prior.

Biogen’s second-quarter earnings report said the monoclonal antibody made $955.9 million globally in multiple sclerosis in the first half of 2023, which is an $81.1 million decrease from $1.037 billion in the same time last year, but still the most of any single drug. The company explained that this 7.8% drop was due to reimbursement obstacles, increased competition and “unfavorable channel dynamics.”

“We are also aware of a potential biosimilar entrant of Tysabri that may enter the US and European markets in 2023,” Biogen said in the earnings document released in July.

Last year, Biogen filed a patent infringement case against Sandoz and the biosimilar’s developer Polpharma Biologics. The suit, filed at the US District Court of Delaware, was made just after Sandoz revealed that the FDA had accepted its BLA for the biosimilar in September 2022. In June, the court declined Biogen’s request for a preliminary injunction.

In a deal secured in 2019, Polpharma agreed to manufacture and supply the biosimilar’s active ingredients, while Sandoz would distribute it globally. Both Tysabri and Tyruko are administered intravenously, with similar dosing regimens.

Meanwhile, Tysabri is in another court case. Roche filed a suit in the US District Court for the Northern District of California in February, alleging that Biogen used licensed technologies to manufacture the antibody. Roche claims it is owed royalties on top of interests and costs, starting from December 2018, with the argument that even though the patents expired, Biogen was still benefiting from a stockpile of antibodies manufactured before then.

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