Italy probes Biogen for allegedly hindering sales of rival's MS drug
Investigation into Biogen's Practices and Impact on MS Drug Market
Background of the Investigation
MILAN, May 27 (Reuters) - 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.
Details of the MS Drug and Associated Testing
Natalizumab and the Anti-JCV Test
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.
Allegations Against Biogen
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.
Economic Impact and Market Competition
Cost Implications for Italy's National Health Service
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).
Importance of Biosimilars for Market Competition
Regulator's Statement on Biosimilars
"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.
Additional Information
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(Reporting by Cristina Carlevaro, editing by Giulia Segreti and Alexander Smith)
