Italy’s antitrust agency, the Italian Competition Authority (AGCM), is investigating Biogen and its Italian subsidiary over allegations that the company abused its market position in testing the multiple sclerosis drug Tysabri (natalizumab).
Biogen’s action “appears to be aimed at eliminating competitor Sandoz,” which sells a cheaper biosimilar of Tysabri known as Tilco, AGCM said in a release.
Biogen’s original drug will go off patent in 2024, and Sandoz is selling its version for about 20% less than Biogen’s drug, according to the release.
The problem is that this drug can cause serious and rare side effects that affect the central nervous system, so patients must undergo a so-called anti-JCV test before and during use of the drug.
Biogen, which itself sells its test as Stratify, makes its use conditional on purchasing Tysabri, the AGCM said in a statement, “refusing its commercialization to patients treated with competing biosimilars.”
“By leveraging the anti-JCV Stratify trial, Biogen appears to be eliminating and/or limiting competition from Sandoz in the market for multiple sclerosis drugs, including natalizumab,” the agency added.
The company has now carried out an “inspection on Biogen’s Italian premises” on May 26 “with the assistance of the Special Antitrust Division of the Italian Financial Police (Guardia di Finanza).”
Sandoz’s anti-JCV assay was put to practical use when Sandoz was delayed in launching a biosimilar in the United States. After testing-related setbacks, Sandoz ended up working with LabCorp to develop a competing product to Stratify in partnership with Biogen’s Quest Diagnostics.
