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Dutch regulator investigates Biogen over MS drug blood test

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The Netherlands’ competition regulator is investigating whether Biogen restricted access to a blood test used to assess a serious risk linked to its multiple sclerosis drug Tysabri. The ACM says the arrangement may hinder competitors and affect prices, supply and patient choice.

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The Dutch competition regulator has opened an investigation into whether drugmaker Biogen may have abused a strong position in medicines for multiple sclerosis by restricting access to a blood test used to assess a potentially life-threatening side effect of its treatment.

The Authority for Consumers and Markets (ACM) is examining how Biogen makes the Stratify test available. The test is used for patients taking, or considering, Tysabri, whose active ingredient is natalizumab. Treatment with natalizumab carries a risk of a serious brain disease, and the test can help assess that risk, according to ANP.

The test is available only to patients receiving Biogen’s medicine or considering that treatment. The ACM says this may hinder existing and potential competitors, with possible consequences for prices, supply and patients’ freedom to choose. The investigation concerns a possible breach; the regulator has not announced a finding of wrongdoing.

Italy’s competition authority has opened a similar investigation into Biogen, ANP reported.

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