Testing Italy’s patience: Biogen investigated over alleged abuse in MS treatment market

The Italian Competition Authority (ICA) has launched an investigation into whether Biogen has used its blockbuster multiple sclerosis drug Tysabri and an accompanying screening test to keep biosimilar rival Sandoz out of the market. The case is a neat illustration of the competition law risks that arise when a company leverages its strong position in one market to hinder rivals in an adjacent market. It is also a reminder that the pharma sector remains an enforcement priority for antitrust authorities across Europe.

Background

Natalizumab (NZB) is a second-line treatment for patients with severe multiple sclerosis. It is administered in hospitals, typically over long treatment cycles. As NZB can cause a rare, potentially fatal side effect, patients are given a screening test (known as an ‘anti-JCV’ test) before starting treatment, and every six months thereafter.

Biogen is alleged to be dominant in two distinct markets:

1. Multiple sclerosis medicines containing NZB. Biogen has marketed its originator NZB medicine, Tysabri, for over 15 years. Following expiry of Biogen’s patent protection in 2024, Sandoz introduced Tyruko, a biosimilar that works in the same way as Tysabri. The ICA notes that Sandoz’s share of the Italian NZB market remains relatively low, even though Tyruko is 20% cheaper than Tysabri.
2. Screening tests for patients using NZB medicines. There are currently two available anti-JCV tests: Biogen’s ‘Stratify’ test and Sandoz’s more recently developed ‘ImmunoWell’ test. According to the ICA, Stratify was the only authorised screening test until 2022 and has effectively become the “reference standard” within the medical community.

The alleged abusive conduct

The ICA is concerned that Biogen may have restricted competition from Sandoz in the NZB medicines market by “leveraging” its Stratify screening test. Specifically, Biogen is alleged to have:

1. made the use of its Stratify test conditional on the purchase of its Tysabri drug (i.e. bundling Stratify with Tysabri); and
2. refused to make the Stratify test available to patients receiving Sandoz’s Tyruko drug.

The ICA notes that Biogen may have also:

1. filed several divisional patents aimed at tying the Stratify test to Tysabri, which either have been found invalid or are pending review; and
2. provided healthcare facilities with misleading information casting doubt on the possibility of using the Stratify test with NZB medicines other than Tysabri.

The ICA is concerned that these practices “seem to have deprived the National Health Service of the cost advantages associated with biosimilars, since Sandoz’s drug would generate savings of at least 20% compared with Biogen’s originator”.

Key takeways

1. The pharma sector remains an enforcement priority for competition authorities across Europe. Regulators are particularly concerned about exclusionary conduct by originators which may deprive patients of access to cheaper generic or biosimilar alternatives. In its press release announcing the investigation, the ICA emphasises that “the spread of biosimilars is […] essential to promote competition, with savings that are crucial for the sustainability of the National Health Service and for funding access to the most innovative therapies for a growing number of patients”. The speed with which the ICA has launched this investigation is also striking: Sandoz issued its complaint in late November last year.
2. The case continues the trend of competition authorities defining product markets narrowly (at the molecule level) in the pharma sector. Originator companies should take heed and adapt their conduct accordingly – particularly in the run-up to patent expiry and potential generic/biosimilar entry. Narrow market definition increases the likelihood of dominance, and dominant companies have a “special responsibility” not to distort competition.
3. This is not the first time that Biogen’s conduct has come under antitrust scrutiny. The ICA is already investigating arrangements between Biogen, Genentech, Novartis and Samsung Bioepis that are alleged to have delayed the launch of Byooviz (a biosimilar version of Lucentis) on the Italian market (see here). And in February this year, Biogen sought to resolve a preliminary European Commission investigation by withdrawing a divisional patent application for another multiple sclerosis drug, Tecfidera (see here). It remains to be seen whether Biogen will fight the new Italian case – or whether it might seek to settle by offering commitments to unbundle Stratify and Tysabri.