Dutch Regulators Probe Biogen Over MS Treatment Competition

The Netherlands Authority for Consumers and Markets, known as ACM, is examining whether Biogen has improperly limited access to its Stratify diagnostic test to patients receiving, or considering treatment with, its multiple sclerosis drug Tysabri, according to a Nov. 10 report by STAT.

The investigation focuses on whether the arrangement disadvantages competing medicines, including Tyruko, a biosimilar version of Tysabri marketed by Swiss pharmaceutical company Sandoz.

The Dutch regulator said in a Nov. 6 statement that restricting access to the diagnostic could prevent existing and prospective suppliers of competing treatments from operating effectively, potentially affecting drug prices, availability and patients’ treatment options.

At the center of the dispute is a blood test used to assess the risk of progressive multifocal leukoencephalopathy, or PML, a rare but potentially fatal brain infection associated with medicines containing natalizumab, the active ingredient in Tysabri.

Patients receiving natalizumab-based treatments require monitoring for the infection risk. Biogen developed Stratify to detect antibodies associated with the JC virus, which can cause PML, and provides the test without charge to eligible Tysabri patients, according to STAT.

The company’s policy means patients receiving competing multiple sclerosis treatments cannot access Stratify through the same arrangement, raising questions about whether control over a diagnostic service could give Biogen an unfair advantage in the pharmaceutical market.

The Dutch inquiry adds to regulatory scrutiny of Biogen’s practices elsewhere in Europe.

Related: Biogen to Acquire Apellis in $5.6 Billion Deal to Expand Rare-Disease Portfolio

Italy’s competition authority opened a similar investigation in May, examining allegations that Biogen used access to Stratify to limit competition from Sandoz’s Tyruko.

According to Reuters’ May 27 report, Italian regulators raised concerns that the arrangement could prevent the country’s public health system from realizing savings associated with biosimilar medicines. The Italian authority estimated that Tyruko could cost at least 20% less than Biogen’s branded treatment.

Biogen said at the time that it was cooperating fully with Italian authorities following an inspection of its Milan offices, Reuters reported.

The Dutch and Italian investigations highlight the growing importance of diagnostic testing in competition disputes involving specialty medicines. Unlike conventional generic drugs, biosimilars are highly similar versions of complex biological treatments and can offer lower-cost alternatives after competing products enter the market.

However, access to associated diagnostic services can influence whether doctors and patients are willing or able to switch treatments.

According to an analysis published Nov. 6 by law firm Van Bael & Bellis, Sandoz also offers a separate diagnostic test, ImmunoWell, without charge. The firm noted that Stratify benefits from a longer history of supporting clinical data, potentially influencing physicians’ preferences.

The ACM said its investigation will determine whether Biogen’s conduct violates competition law, emphasizing that the inquiry does not establish wrongdoing.

Source: STAT