Italy’s antitrust authority (AGCM) said on Wednesday it had launched an investigation into Biogen Italia and its U.S. parent company, Biogen, over allegations that they attempted to block rival drugmaker Sandoz from marketing a lower-cost multiple sclerosis treatment.
Biogen said in an emailed statement that it is “fully cooperating with the authorities” and confirmed that AGCM officials visited its Milan offices on Tuesday morning.
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Treatment with natalizumab, the active ingredient used in multiple sclerosis therapy, can cause a rare side effect. Because of this risk, patients must undergo a specific anti-JCV test before starting treatment and regularly throughout the therapy to monitor potential complications.
Italy’s antitrust authority (AGCM) alleged that Biogen used its anti-JCV Stratify test to restrict competition from Sandoz by linking the test exclusively to purchases of its own MS drug, Tysabri, while refusing to make the test commercially available for patients using Sandoz’s biosimilar treatment, Tyruko.
The watchdog also said Biogen’s practices may be limiting potential savings for Italy’s national health service, noting that Sandoz’s drug could cost at least 20% less than Biogen’s treatment.
The treatments are administered exclusively in public hospitals through long-term therapy cycles, with each package priced at more than €1,000 ($1,164).
“The use of biosimilars is fundamental for stronger market competition, and the resulting savings are crucial to ensure the sustainability of the national health system and to fund access to more innovative therapies for a growing number of patients,” the regulator said in a statement.
