Sanofi escapes fine in EU mismarketing case
Sanofi will not be fined for disparaging an influenza vaccine sold by rival CSL in a marketing campaign that ran in the EU, after the European Commission accepted its remediation commitments.
The EU launched an investigation earlier this year into a promotional campaign for Sanofi's enhanced flu vaccine Efluelda, used to protect vulnerable patients with risk factors for severe flu aged over 60, and statements made therein about the only competing product, Fluad from CSL Seqirus.
The campaign under scrutiny, which ran during the 2025 flu season, primarily targeted healthcare professionals in Germany and France and allegedly disparaged Fluad by portraying it as inferior to Efluelda. The Commission was concerned that this position contradicted the findings of the European Centre for Disease Control (ECDC), as well as national immunisation technical advisory groups in Germany and France.
"To address the Commission's preliminary concerns, Sanofi offered to engage in proactive communication to rectify and undo the possible effects of the potentially misleading messages shared regarding Fluad, as well as to refrain from any communication portraying Fluad negatively or casting doubt about its performance," said the Commission in a statement published this morning.
It also said it had market-tested the measures proposed by Sanofi over the summer, concluding they were sufficient, and will appoint a trustee to monitor its compliance.
The EU investigation followed unannounced inspections of Sanofi offices in France and Germany in September 2025, which the EU said took place because of concerns that Sanofi had violated EU antitrust rules that prohibit abuses of a dominant market position.
Under EU law, companies can be fined up to 10% of their global turnover if it is proved they have committed anticompetitive actions, but Sanofi seems to have averted that threat.
The company has committed to refrain from making any statements that Efluelda is more effective than Fluad, or cast aspersions on the safety or efficacy of CSL Seqirus' product, either in promotional materials or information provided to key opinion leaders (KOLs), until March 2030.
Moreover, Sanofi has agreed to publish statements on its German and French websites for two years, acknowledging that "applicable national vaccination recommendations treat Fluad and Efluelda as equivalent in protecting elderly people against the flu, both having a robust evidence base."
Messages to that effect will also have to be sent to any healthcare practitioners and KOLs targeted by Sanofi's disparagement campaign against Fluad.
The Commission said it had "concluded that the commitments proposed by Sanofi will address its competition concerns related to the potential disparagement of Fluad [and] has therefore decided to make them legally binding on Sanofi."
