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Sandoz Launches First Natalizumab Biosimilar in the US

Nov 17, 2025

On 17 November 2025, Sandoz announced the US launch of Tyruko®, biosimilar to Biogen’s Tysabri® (natalizumab).  Tyruko® is the only natalizumab biosimilar approved (August 2023) and launched in the US and is available for all reference indications.

Tyruko® was developed by Polpharma Biologics pursuant to a global commercialisation agreement with Sandoz reached in 2019.  As part of the agreement, Sandoz has exclusive rights to commercialise and distribute the product in all markets.

Tyruko® was approved in Europe (September 2023) and Australia (April 2025) and was recommended for listing on Australia’s Pharmaceutical Benefits Scheme (PBS) under the same circumstances as Biogen’s Tysabri® in April 2025.