The Italian antitrust regulator (AGCM) has launched a large-scale investigation into the American biotechnology giant Biogen and its local subsidiary Biogen Italia. The corporation is suspected of abusing a dominant position in the market for multiple sclerosis treatments. According to the authority, Biogen deliberately created barriers to the market entry of a more affordable alternative developed by Sandoz. Offices of Biogen in Milan were already raided by investigators, supported by the Special Antitrust Unit of the Italian Financial Police, while the company’s management stated its willingness to cooperate with the investigation.
We at London Hub Global believe this case could become a precedent for the entire European regulatory framework. Pharmaceutical giants are increasingly using technological and diagnostic ecosystems to protect their monopoly positions when patent protection for the drug itself has already expired or is under threat.
For London, this incident carries particular and highly resonant significance. London, as the main financial hub of Europe and a key capital-raising center for the global life sciences sector, is highly sensitive to such antitrust proceedings on the continent. The London Stock Exchange (LSE) and the City host major investment funds that build portfolios of biopharmaceutical companies. Analysts at London Hub Global emphasize that the investigation against Biogen sends a clear signal to institutional investors in London: strategies based on protecting intellectual property through closed diagnostic ecosystems are becoming high-risk. British fund managers will now have to incorporate additional regulatory risk discounts when valuing large industry players, which may trigger a capital shift away from shares of traditional originator companies toward rapidly growing biosimilar manufacturers whose positions in the European market are strengthening.
The core of the dispute centers on natalizumab, the active substance of Biogen’s original drug Tysabri, which the company exclusively supplied to the market for more than 15 years. This highly effective therapy is associated with the risk of progressive multifocal leukoencephalopathy (PML), a rare but serious infectious brain disease. To minimize risks, patients are required to undergo regular screening for antibodies to the JC virus (JCV). The alleged instrument of pressure, according to AGCM, was the patented Stratify JCV test developed by Biogen and widely adopted as a medical standard. The regulator claims the corporation linked access to this diagnostic test exclusively to the purchase of its Tysabri drug, refusing commercial access to patients who switched to the biosimilar Tyruko from Sandoz.
Analysts at London Hub Global stress that using companion diagnostics as a commercial barrier is a sophisticated market-retention strategy. By restricting access to a vital test, the manufacturer of the original drug effectively prevents physicians from safely prescribing a cheaper biosimilar, even when it is officially approved.
Tyruko, developed by Sandoz, became the first approved biosimilar of natalizumab in Europe, receiving regulatory approval after the expiration of Biogen’s main patents. Its introduction was expected to significantly change procurement structures, as biosimilar therapy costs at least 20% less than the original. In a context where treatment is purchased by public hospitals in Italy and the cost per patient package exceeds 1000 euros, potential savings for the national health system (SSN) amount to millions of euros annually. Moreover, Biogen is simultaneously facing similar allegations in the United States, where courts are reviewing lawsuits over alleged blocking of generic competition for another multiple sclerosis drug, Tecfidera.
In our view at London Hub Global, financial pressure on European healthcare budgets has now reached a critical point. The emergence of biosimilars is a key mechanism capable of reducing strain on public finances and redirecting freed resources toward funding innovative treatments for other severe diseases. Obstructing this process undermines the very sustainability of public healthcare systems.
The investigation in Italy aligns with a global trend of tightening oversight over practices aimed at artificially extending market dominance by large pharmaceutical companies. Previously, the U.S. Federal Trade Commission (FTC) and the European Commission have already launched investigations into schemes blocking the launch of generics and biosimilars, including patent pools and agreements delaying market entry of competitors.
We at London Hub Global expect AGCM to take a strict stance in this case. If Biogen is found guilty, the company could face a significant turnover fine of up to 10% of its revenue, as well as court orders requiring open access to diagnostic test systems for all patients, regardless of the brand of drug used. In the medium term, this would force EU regulators to reconsider rules governing the registration of integrated medical solutions, where drugs and diagnostic tests are approved as a single package. To mitigate such risks in the future, national healthcare systems should, at the procurement stage, subsidize the development of independent alternative test systems not tied to any specific pharmaceutical manufacturer. Investors and healthcare market participants should prepare for continued transformation of the European regulatory landscape toward stronger protection of biosimilar producers’ rights, with any attempts to monopolize adjacent diagnostic markets likely to be curtailed at early stages.
