Belgian Competition Authority Investigating Practices Aimed at Blocking Biosimilars

In the United States, biosimilars have faced numerous challenges, and some of those—as related to exclusionary contracts, bundled rebates, and multiproduct bundling practices related to innovator products—have even become the subject of antitrust scrutiny and related lawsuits.

While those problems are particularly apparent in the US context, international activity shows that they are not unique to the United States; this month, the Belgian Competition Authority, which contributes to implementing Belgium’s competition policy by addressing anticompetitive practices, announced that it is conducting inspections of some drug makers.

The on-the-premises inspections are taking place at companies suspected of having implemented “restrictive practices aimed at limiting, delaying or even preventing the entry into the market or the expansion of biosimilar medicines competing with existing medicines,” the agency said in a statement, and these practices could represent infringements of the law.

The duration of the Belgian investigation into these companies will depend, said the authority, on factors including the degree of complexity of the case, drug makers’ cooperation with the authority, and the companies’ exercise of their rights of defense.

According to the Belgian newspaper De Morgen, the investigation includes assessing brand-name biologics that continue to be preferred even after biosimilars become commercially available. Other concerns include whether brand-name biologics makers are using the threat of withholding discounts to keep hospital systems from switching to biosimilars.

Improving the Belgian biosimilars market is important, say stakeholders, as the market has remained relatively small in comparison to other European countries. According to a recent KPMG report, some of the reasons for Belgium’s comparatively low biosimilar uptake include tender criteria that often favor innovator drugs, such as distance to the manufacturing plant, speed of delivery, or availability of single-dose packaging.

According to the report’s authors, “physicians might have an incentive to add these originator-favoring award-criteria to the tender procedures, as the outcome of the tender may affect their personal grants and personal sponsorships from the manufacturers which produce the originator medicines.”