Sandoz Biosimilar Pricing Dispute Triggers Italian Investigation Into Biogen
Milan: Italy's antitrust authority (AGCM) said on Wednesday it had opened an investigation into Biogen Italia and its U.S. parent Biogen over allegedly trying to prevent rival drugmaker Sandoz from offering a cheaper multiple sclerosis drug.
Biogen said in an emailed statement that it was "fully cooperating with the authorities" and confirmed representatives of the AGCM visited its Milan offices on Tuesday morning.
Treatment with natalizumab, the active ingredient in the MS drug, can cause a rare collateral effect. This means patients have to undergo a specific test - known as anti-JCV - before and periodically during the therapy, to assess the risks.
AGCM said Biogen allegedly used its anti-JCV Stratify test to exclude or limit competition from Sandoz by tying the use of the test to the purchase of its own medicine - Tysabri - and refusing to make it commercially available to patients treated with the competitor's biosimilar drug - Tyruko.
Biogen's policies are also limiting potential savings for Italy's national health service, the watchdog said, noting that Sandoz's drug could cost at least 20% less than Biogen's.
The treatments are exclusively carried out in public hospitals, over long therapy cycles, with each pack costing 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.
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