Italy’s antitrust authority has launched an investigation into the pharmaceutical giant Biogen over allegations of abusing its dominant market position. The probe targets Biogen Italia and its parent company, Biogen Inc., following claims that they executed a calculated strategy to lock out Sandoz, a competing drug manufacturer. According to the regulator, this conduct appears designed to limit competition in the market for multiple sclerosis treatments that rely on the active ingredient natalizumab, a direct violation of European competition laws under Article 102 of the Treaty on the Functioning of the European Union.
For more than fifteen years, Biogen held an effective monopoly over this specific treatment, commercializing it under the brand name Tysabri. The medication is vital for patients battling severe, rapidly progressing forms of multiple sclerosis. The landscape shifted when Biogen’s patents expired, allowing Sandoz to enter the market with a biosimilar alternative called Tyruko. Biosimilars function identically to the original brand-name drugs but enter the market at a significantly lower cost. However, because natalizumab treatments carry a risk of a rare but severe central nervous system side effect known as PML, patients must undergo regular screening using a highly specialized anti-JCV test before and during their therapy cycle.
The crux of the antitrust allegation hinges on this diagnostic test. Biogen owns the proprietary “Stratify” anti-JCV test, which served as the medical community’s exclusive standard for screening. The competition authority alleges that Biogen is leveraging its control over this essential diagnostic tool to suffocate Sandoz’s market entry. Biogen is reportedly tying the availability of the Stratify test directly to the purchase of its own expensive medication, while flatly refusing to make the testing protocol commercially available to hospitals treating patients with Sandoz’s more affordable biosimilar.
This gatekeeping strategy does more than just squeeze out a corporate rival; it places a heavy financial burden on the public purse. Sandoz’s biosimilar promises a minimum savings of twenty percent compared to Biogen’s original drug. Given that these specialized hospital-administered therapies cost well over one thousand euros per package and require long-term treatment cycles, the financial stakes for public healthcare systems are immense. By artificially blocking a cheaper alternative, such exclusionary tactics directly undermine the financial sustainability of national health services.
Public health advocates and regulators emphasize that the successful adoption of biosimilars is crucial for driving down prices, which in turn frees up vital funding to grant more patients access to cutting-edge medical care. In this light, suppressing fair market competition ceases to be a mere corporate dispute and becomes a direct threat to public healthcare access. Highlighting the seriousness of the situation, antitrust officials, backed by the specialized financial police unit Guardia di Finanza, recently conducted a surprise inspection at Biogen’s Italian headquarters to secure evidence as the formal investigation gets underway.
