Italy opens antitrust investigation into Biogen over alleged efforts to block Sandoz multiple sclerosis biosimilar
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| Roberto Rustichelli posing in his office beside the Italian and European Union flags |
ROME - A life-saving medicine, a diagnostic test considered indispensable and a very serious allegation of abuse of dominant position: Italy's Antitrust Authority has turned the spotlight on Biogen and the multiple sclerosis treatment market. At the centre of the investigation is the suspicion that the pharmaceutical giant may have hindered the entry of Sandoz's biosimilar, thereby limiting competition and potential savings for the National Health Service. A case that intertwines healthcare, economic interests and patients' right to access more sustainable treatments.
The aim was allegedly to exclude competitor Sandoz from the multiple sclerosis medicines market
Italy Antitrust: investigation launched into Biogen over multiple sclerosis medicines. According to the Italian Competition and Market Authority (AGCM), the Biogen group allegedly implemented a strategy aimed at excluding and limiting competition from newcomer Sandoz in the market for natalizumab-based medicines used to treat multiple sclerosis. The AGCM has opened an investigation into Biogen Italia S.r.l. and its parent company Biogen Inc. for alleged abuse of dominant position. According to the Authority, the conduct of the two companies was allegedly intended to exclude competitor Sandoz from the supply of multiple sclerosis medicines based on the active ingredient natalizumab, in breach of Article 102 TFEU. Natalizumab is a therapy used for the treatment of multiple sclerosis in patients with a severe and rapidly evolving form of the disease. For more than 15 years, Biogen marketed the only natalizumab-based originator medicine, Tysabri. From 2024 onwards, following the expiry of the patents, Sandoz attempted to market a biosimilar medicine — equivalent but at a significantly lower price than the originator — also based on natalizumab, called Tyruko.
Biogen allegedly held a dominant position in the supply of the anti-JCV test
As natalizumab treatment may cause a rare side effect, patients are required, before starting therapy and periodically thereafter, to undergo a specific test (the anti-JCV test) in order to assess the risk of developing a serious demyelinating disease of the central nervous system known as PML. According to the Antitrust Authority, Biogen allegedly holds a dominant position in the supply of the anti-JCV test (called Stratify) because, until 2022, it was the only test authorised for screening purposes and effectively became the reference standard within the medical community.
In this context, by leveraging the Stratify anti-JCV test, Biogen allegedly excluded and/or limited Sandoz's competition in the market for natalizumab-based medicines used to treat multiple sclerosis, because it linked the use of this test to the purchase of its own medicine and refused to make it commercially available for patients treated with the competing biosimilar.
Medicines with a market price of more than one thousand euros per pack
Moreover, these practices would allegedly undermine the cost-saving advantages of biosimilars for the National Health Service, given that Sandoz's medicine would generate savings of at least 20% compared with Biogen's originator product. The AGCM pointed out that these medicines have a market price of more than one thousand euros per pack, therefore representing a very high cost for pharmaceutical expenditure, and that they are administered exclusively in hospitals over long treatment cycles. The spread of biosimilars is therefore considered essential to trigger virtuous mechanisms of market competitiveness, while the resulting savings are crucial for the sustainability of the National Health Service and for financing access to increasingly innovative therapies for a growing number of patients.
Italian Antitrust Special Unit of the Guardia di Finanza
For this reason, according to the Italian Competition and Market Authority, strategies that hinder and/or prevent the development of competition between originator medicines and biosimilars may constitute a breach of antitrust rules, with serious effects on healthcare expenditure. Consequently, safeguarding competition represents one of the fundamental pillars in protecting the right to health and access to innovative treatments. On Tuesday 26 May 2026, officials from the Antitrust Authority, assisted by the Italian Antitrust Special Unit of the Guardia di Finanza, carried out inspection activities at Biogen's Italian headquarters.
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