Italy Opens Competition Probe Into Biogen Over Multiple Sclerosis Drug Practices

Key Takeaways

• Italian Regulators Launch Probe: Italy’s Competition Authority has opened an antitrust investigation into Biogen and its Italian subsidiary over an alleged abuse of dominant position tied to multiple sclerosis treatments containing natalizumab.
• Testing Access at Center of Case: Regulators allege Biogen leveraged control of its anti-JCV Stratify test by linking access to the test with use of its own drug, potentially limiting adoption of competing biosimilars.
• Sandoz Biosimilar Triggered Scrutiny: The investigation follows the 2024 launch of Sandoz’s lower-cost natalizumab biosimilar, Tyruko, after patent protections on Biogen’s Tysabri expired.
• Healthcare Cost Concerns Loom Large: Italian authorities said the biosimilar could generate savings of at least 20% compared with Biogen’s originator drug, highlighting broader concerns around pharmaceutical spending and public healthcare sustainability.
• Competition and Healthcare Increasingly Intertwined: The case reflects growing European regulatory focus on whether pharmaceutical companies are using surrounding clinical infrastructure, testing systems, or operational dependencies to blunt biosimilar competition after exclusivity periods end.

Deep Dive

Italy’s competition watchdog said this week it has opened a probe into Biogen and its Italian subsidiary over allegations the company used control of a critical screening test to box out a lower-cost rival in the market for multiple sclerosis drugs containing natalizumab. The accusation is technical. The implications are not.

For years, Biogen’s Tysabri occupied the field largely alone. Patients with rapidly evolving severe multiple sclerosis received the drug through long hospital treatment cycles, while doctors relied on a companion screening tool known as the anti-JCV Stratify test to monitor the risk of progressive multifocal leukoencephalopathy, or PML, a rare but potentially devastating neurological condition associated with natalizumab therapies.

That test matters because nobody wants to discover, midway through treatment, that the medicine suppressing one neurological disease may have opened the door to another.

According to the Italian Competition Authority, the Stratify test became more than a medical tool. It became infrastructure. Until 2022, regulators said, it was the only authorized screening test of its kind and had effectively become the reference standard within the medical community. If physicians were prescribing natalizumab, they were using Stratify.

Then the patent clock ran out. In 2024, Sandoz entered the market with Tyruko, a biosimilar version of natalizumab offered at what authorities described as a significantly lower price than Biogen’s originator drug. Biosimilars rarely arrive with the glamour of a new therapy. They arrive with spreadsheets, procurement discussions, and budget meetings. Health system officials quietly calculating what happens if a treatment costing more than €1,000 per pack suddenly faces meaningful price competition.

The Italian authority now alleges Biogen used its position in the anti-JCV testing market to slow that competition down.

Regulators claim the company conditioned access to the Stratify test on the purchase of its own drug while refusing to make the test commercially available for patients receiving the competing biosimilar. If true, the strategy would amount to something deceptively simple: allowing the market to open on paper while making it substantially harder to function in practice.

Drug markets do not operate like ordinary consumer markets, particularly in specialized therapies administered through hospitals. Physicians build routines around familiar protocols. Hospitals standardize around known testing methods. Patients with severe conditions are rarely eager participants in pharmaceutical disruption. Once a product ecosystem embeds itself deeply enough into clinical practice, the surrounding systems can become just as powerful as the drug itself.

Competition authorities across Europe have become increasingly attentive to that reality, especially as biosimilars move into markets historically dominated by a single manufacturer. The fight is no longer simply about patents expiring. It is about what happens afterward. Whether the market genuinely opens. Whether incumbents accept erosion of dominance or construct softer barriers that accomplish much the same thing without ever explicitly locking the door.

The Authority said the spread of biosimilars is essential for the sustainability of the National Health Service and for funding access to newer therapies. Sandoz’s product, it noted, could generate savings of at least 20% compared with Biogen’s original drug. In a healthcare system already straining under pharmaceutical expenditure, those percentages stop looking abstract very quickly.

There is also something quietly revealing in the language regulators chose to use. The Authority framed competition protection not merely as an economic concern, but as part of safeguarding “the right to health and access to innovative care.” Antitrust enforcement in pharmaceutical markets increasingly carries that tone in Europe. The regulator is not simply asking whether a company defended market share too aggressively. It is asking who ultimately absorbs the cost when competition fails to materialize after exclusivity ends.

Usually, the answer is taxpayers. Officials from Italy’s competition authority, assisted by the Guardia di Finanza’s Special Antitrust Unit, carried out inspections at Biogen’s Italian offices Tuesday as part of the investigation. The probe concerns a possible abuse of dominant position under Article 102 TFEU.

For now, those are allegations, not findings. But the case lands at an awkward moment for large pharmaceutical firms operating in Europe, where governments want the savings biosimilars promise while also demanding continued investment in high-risk drug development.

Everyone wants cheaper medicines. Everyone also wants the next breakthrough therapy. The industry has spent years arguing those ambitions are harder to reconcile than politicians pretend. But Italy’s regulator appears unconvinced that justifies using a diagnostic bottleneck to protect an aging franchise.

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