Italy’s competition watchdog has opened a probe into Biogen over claims it tried to block access to a cheaper MS drug.
The investigation concerns Biogen Italia and its US parent, Biogen, over allegations it tried to prevent rival drugmaker Sandoz from offering a cheaper multiple sclerosis treatment.
Italy’s antitrust authority, AGCM, said on Wednesday, May 27, that it had opened the investigation.
Biogen said in an emailed statement that it was “fully cooperating with the authorities”.
The company also confirmed that AGCM representatives visited its Milan offices on Tuesday morning.
The case centres on natalizumab, the active ingredient in the MS drug.
Treatment with natalizumab can cause a rare side effect, meaning patients need a specific test before and during therapy to assess their risk.
The test is known as anti-JCV and checks for antibodies linked to the John Cunningham virus.
AGCM said Biogen allegedly used its anti-JCV Stratify test to exclude or limit competition from Sandoz.
The authority alleged Biogen tied use of the test to the purchase of its own medicine, Tysabri, and refused to make it commercially available to patients treated with Sandoz’s biosimilar drug, Tyruko.
A biosimilar is a medicine designed to be highly similar to an existing biological drug, with no clinically meaningful differences in safety, quality or effectiveness.
AGCM said Biogen’s policies were also limiting potential savings for Italy’s national health service.
The regulator said Sandoz’s drug could cost at least 20 per cent less than Biogen’s.
The treatments are carried out exclusively in public hospitals over long therapy cycles, with each pack costing more than €1,000, or US$1,164.
The regulator said: “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.”
