Belgian Competition Authority Accuses Roche of Blocking Biosimilar Competition

The Belgian Competition Authority (BCA) has issued (17 March) a statement of objections against the Roche Group, including its Belgian subsidiary Roche SA, over alleged anti-competitive practices aimed at delaying the entry of biosimilars for two of its anticancer medicines between 2017 and 2020.

According to the BCA, Roche implemented a strategy to prevent hospitals from switching to biosimilars by offering financial incentives that discouraged competitive tenders. The pharmaceutical giant is also accused of spreading misleading information about the safety and efficacy of using biosimilars in combination therapy.

The medicines in question contain the active substances Rituximab and Trastuzumab, which are widely used in the treatment of certain cancers. At the time, Roche held a dominant market position for these drugs, and the BCA believes its actions may have led hospitals to continue sourcing from Roche exclusively, despite the availability of biosimilar alternatives. Such practices, the authority argues, could constitute an abuse of dominance under both Belgian and EU competition law.

If confirmed, these actions could have significantly impacted healthcare costs. Biosimilars typically drive down the prices of both reference drugs and their own alternatives, leading to substantial savings for healthcare systems. By delaying their entry into the Belgian market, Roche’s alleged tactics may have kept drug costs artificially high.

The issuance of a statement of objections is a preliminary step in the BCA’s investigation and does not determine the final outcome of the case. Roche now has the opportunity to respond to the allegations, present its defense, and review the investigation file.

This case underscores the growing scrutiny of pharmaceutical companies’ market strategies in Europe, particularly regarding competition and pricing practices in the healthcare sector. The BCA’s findings could have wider implications for how biosimilar competition is fostered and regulated in Belgium and beyond.

The investigation remains ongoing, with further developments expected as Roche submits its response to the allegations.

Source: https://www.bma-abc.be/sites/default/files/content/download/files/20250317_Persbericht_11_BMA_0.pdf

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