Italy’s antitrust agency, the Italian Competition Authority (AGCM), is investigating Biogen and its Italian subsidiary over claims it is abusing its market position regarding a test for its multiple sclerosis drug Tysabri (natalizumab).
The AGCM said in a release that Biogen’s actions appear “to be aimed at excluding their competitor Sandoz,” which markets a cheaper biosimilar to Tysabri known as Tyruko.
Biogen’s original drug lost its patent in 2024, and Sandoz sells its version at around 20% cheaper than Biogen’s med, according to the release.
The issue is that because the drug can cause a serious but rare side effect impacting the central nervous system, patients need to take what’s called an anti-JCV test, before and during the drug’s use.
Biogen itself markets that test as Stratify—but makes the use of its test conditional on the purchase of Tysabri, the AGCM contends, and “refuses to make it commercially available for patients treated with the competing biosimilar,” it said in a statement.
“By leveraging its anti-JCV Stratify test, Biogen appears to be excluding and/or limiting competition from Sandoz in the market for multiple sclerosis drugs containing natalizumab,” the Authority added.
It has now carried out “inspections at the Italian premises of Biogen”, on May 26, which were “assisted by the Special Antitrust Unit of the Italian Financial Police (Guardia di Finanza).”
The anti-JCV assay actually came into play for Sandoz when the company suffered a delay in launching its biosimilar in the United States. After a holdup related to the test, Sandoz eventually went with Labcorp to develop a competitor to Biogen’s Quest Diagnostics-partnered Stratify.