Nine months after raiding the offices of Sanofi in an unannounced inspection, the European Commission says it has started formal proceedings in an antitrust investigation against the French drugmaker.
The probe surrounds Sanofi’s marketing of its flu vaccine for at-risk seniors, Efluelda, and whether it “disparages” its lone rival in the indication, CSL Seqirus’ Fluad, the EU said in a release.
The Commission wrote that it is “concerned that Sanofi pursued a misleading communication campaign” which portrays Fluad “as inferior to Efluelda, going against national vaccination recommendations in several Member States.”
The campaign primarily targeted healthcare professionals in Germany and France, the EC added.
The Commission says that Sanofi’s messaging suggests that Fluad is backed by weaker evidence of its efficacy, contradicting advice from the European Centre for Disease Control and from national immunization advisory committees in Germany and France.
The EC also said that Sanofi made “misleading and/or inaccurate representations” of national vaccine recommendations and that the company claims that there are “unresolved scientific objections” to national recommendations from medical societies in Germany.
In both of the markets, the EC added that Sanofi is in a “dominant position” in its competition with CSL.
In an email response, a Sanofi spokesperson pointed out that the Commission has adopted a preliminary assessment through which the company may address the EC’s concerns.
“Sanofi is confident that it has acted, and continues to act, in full compliance with all applicable laws and regulations, including competition law,” the spokesperson added. “The opening of formal proceedings is a procedural step and does not prejudge the outcome of the investigation.”
In September of last year, investigators inspected Sanofi offices in France and Germany.
In its last fiscal year, CSL reported sales of trivalent Fluad at $901 million, which were down 14%, with the company chalking up the decline to decreased demand in the United States.
Sanofi does not report the sales of its individual vaccines. Efluelda is a quadrivalent shot and is sold as Fluzone HD in the U.S.
In 2022, CSL’s Vifor unit was the subject of an EC antitrust probe surrounding its “potential disparagement” of Pharmacosmos’ high-dose intravenous iron replacement therapy Monofer, a European competitor to Vifor’s flagship iron medicine, Ferinject. In 2024, CSL cleared up the investigation with an ad campaign that addressed the alleged anticompetitive actions.