On 27 May 2026, Fierce Pharma reported that Italy’s competition regulator (AGCM) has commenced an investigation into Biogen’s alleged abuse of its dominant position in the multiple sclerosis drug market.
Biogen markets Tysabri® (natalizumab) for the treatment of multiple sclerosis. Treatment with natalizumab can cause a rare but serious side effect, which means that patients are required to undergo a specific test (the ‘anti-JCV test’) before and during treatment with natalizumab. AGCM is concerned that Biogen is using its anti-JCV Stratify test to exclude or limit competition from Sandoz by tying the use of the test to the purchase of Tysabri®, and refusing to make it commercially available to patients treated with Sandoz’s natalizumab product, Tyruko®.
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® is approved in multiple markets, including the US (August 2023), Europe (September 2023) and Australia (April 2025).