Belgian Competition Authority Accuses Roche of Hampering Biosimilar Market Entry in Oncology
- 17/03/2025
- News
Today, the Belgian Competition Authority (BCA) accused the Roche group of having implemented a strategy between 2017 and 2020 designed to delay the market entry of biosimilar rivals of its oncology medicines MabThera® (rituximab) and Herceptin® (trastuzumab) (see, attached press release).
According to the BCA, Roche financially encouraged hospitals not to organise public procurement procedures involving Roche and competitors in relevant therapeutic fields and also disseminated incorrect information regarding the use of biosimilars in combination therapy. In the Statement of Objections (SO) which the BCA sent to Roche, the BCA expresses the view that Roche thus abused the dominant position which it occupied at the material time.
In challenging Roche, the BCA is relying on competition law tools to complement the policy objective of successive federal governments to develop the competition offered by biosimilar medicines in a range of therapeutic areas by tightening the rules that require hospitals to deploy such procedures as soon as biosimilar products obtain reimbursement and become practically available on the market (see, Van Bael & Bellis Life Sciences News and Insights of 25 September 2023, 13 February 2024, and 6 March 2024).
In the SO, the BCA is also applying a recognised theory of harm that prevents firms with an established market position from making false and/or derogatory claims regarding the safety or efficacy of the medicines of rivals (see, e.g., Van Bael & Bellis Life Sciences News and Insights of 11 December 2024).
For its part, Roche has already been fined by the Romanian competition authority on account of abusive behaviour with regard to MabThera® and Herceptin® (see, Van Bael & Bellis Life Sciences News and Insights of 16 October 2024).