On November 17, 2025, Sandoz announced the launch of TYRUKO® (natalizumab-sztn) in the United States as the first and only biosimilar for the treatment of relapsing forms of multiple sclerosis. TYRUKO® was approved by FDA in August 2023 to treat all indications covered by Biogen’s TYSABRI®, including relapsing forms of MS and Crohn’s disease in adults.
TYRUKO® was developed by Polpharma Biologics and in 2019, Sandoz and Polpharma entered into a global commercialization agreement under which Polpharma will maintain responsibility for the development of the products as well as manufacturing and supply of the drug substance. Through an exclusive global license, Sandoz has the rights to commercialize and distribute it in all markets.
Biogen’s BPCIA litigation against Sandoz remains pending in the U.S. District Court for the District of Delaware. In June 2023, the court denied Biogen’s motion for a preliminary injunction. The court held that Biogen had not shown irreparable price erosion and loss of market share if Sandoz launches its product before trial and that any harm could not be remedied by damages. The court also held that Biogen did not satisfy the causal nexus requirement because the patents asserted in the PI did not cover the actual product, but instead covered a method of assessing risk of progressive multifocal leukoencephalopathy (PML). The case is set for a 5-day jury trial starting on April 26, 2027.