Rome, May 27 (LaPresse) – The Italian Competition Authority (AGCM) has opened an investigation into Biogen Italia S.r.l. and its parent company Biogen Inc. for alleged abuse of a dominant position. The conduct of the two companies is believed to aim at excluding competitor Sandoz from the supply of drugs for multiple sclerosis based on the active ingredient natalizumab, in violation of Article 102 TFEU. Natalizumab is a therapy for the treatment of multiple sclerosis in patients with a severe and rapidly progressing form of the disease. For over 15 years, Biogen has marketed the only originator drug based on natalizumab, Tysabri. Starting in 2024, after patent expiry, Sandoz attempted to market a biosimilar drug – equivalent but significantly cheaper than the originator – also based on natalizumab, called Tyruko. Treatment with natalizumab, due to a rare side effect, requires patients to undergo before starting therapy and periodically a specific test (anti-JCV test) to assess the risk of developing a severe demyelinating disease of the central nervous system, PML. According to the Authority, Biogen holds a dominant position in the supply of the anti-JCV test (called Stratify) because until 2022 it was the only authorised test for screening and has effectively been the standard reference in the medical community. In this context, Biogen, leveraging the anti-JC Stratify test, would exclude and/or limit Sandoz’s competition in the market for multiple sclerosis medicines based on natalizumab, by tying the use of the test to the purchase of its own drug and refusing to make it commercially available for patients treated with the competitor biosimilar. These practices would also undermine the benefits of biosimilars in terms of costs for the National Health Service, as Sandoz’s drug would generate savings of at least 20% compared to Biogen’s originator.
Antitrust, multiple sclerosis drugs: investigation opened into Biogen
Rome, May 27 (LaPresse) – The Italian Competition Authority (AGCM) has opened an investigation into Biogen Italia S.r.l. and its parent company Biogen Inc. for alleged abuse of a dominant position. The conduct of the two companies is believed to aim at excluding competitor Sandoz from the supply of drugs for multiple sclerosis based on the active ingredient natalizumab, in violation of Article 102 TFEU. Natalizumab is a therapy for the treatment of multiple sclerosis in patients with a severe and rapidly progressing form of the disease. For over 15 years, Biogen has marketed the only originator drug based on natalizumab, Tysabri. Starting in 2024, after patent expiry, Sandoz attempted to market a biosimilar drug – equivalent but significantly cheaper than the originator – also based on natalizumab, called Tyruko. Treatment with natalizumab, due to a rare side effect, requires patients to undergo before starting therapy and periodically a specific test (anti-JCV test) to assess the risk of developing a severe demyelinating disease of the central nervous system, PML. According to the Authority, Biogen holds a dominant position in the supply of the anti-JCV test (called Stratify) because until 2022 it was the only authorised test for screening and has effectively been the standard reference in the medical community. In this context, Biogen, leveraging the anti-JC Stratify test, would exclude and/or limit Sandoz’s competition in the market for multiple sclerosis medicines based on natalizumab, by tying the use of the test to the purchase of its own drug and refusing to make it commercially available for patients treated with the competitor biosimilar. These practices would also undermine the benefits of biosimilars in terms of costs for the National Health Service, as Sandoz’s drug would generate savings of at least 20% compared to Biogen’s originator.
