Brussels opens formal antitrust case against Sanofi over flu vaccine marketing
The European Commission has opened formal proceedings in an antitrust investigation into Sanofi (SNY), nine months after conducting unannounced inspections of the French drugmaker's offices in France and Germany. The probe centers on Sanofi's marketing of its flu vaccine for at-risk seniors, Efluelda, and whether the campaign disparaged its only rival in the indication, Fluad, made by CSL (CSLLY) unit Seqirus.
The Commission said it was concerned that Sanofi had pursued a misleading communication campaign portraying Fluad as inferior to Efluelda, in contradiction of national vaccination recommendations in several member states. The campaign primarily targeted healthcare professionals in Germany and France, the regulator said.
Brussels alleges that Sanofi's messaging implied Fluad was supported by weaker efficacy evidence, contrary to guidance from the European Centre for Disease Control and from national immunization advisory bodies in both countries. The Commission also said Sanofi made misleading or inaccurate representations of national vaccine recommendations, including claims that unresolved scientific objections existed among German medical societies regarding official guidance. The regulator noted that Sanofi holds a dominant position in both markets in its competition with CSL.
A Sanofi spokesperson said the Commission had adopted a preliminary assessment through which the company could address the regulator's concerns, adding that Sanofi was confident it had acted in full compliance with applicable laws, including competition law. The spokesperson characterized the opening of formal proceedings as a procedural step that does not prejudge the investigation's outcome.
CSL reported sales of trivalent Fluad of $901mn in its last fiscal year, down 14 per cent, a decline the company attributed to weaker demand in the United States. Sanofi does not disclose sales for individual vaccines; Efluelda, a quadrivalent shot, is marketed in the United States as Fluzone HD.
The case echoes a similar investigation opened by the Commission in 2022 into CSL's Vifor unit, which was accused of disparaging Pharmacosmos's intravenous iron therapy Monofer in competition with Vifor's own product, Ferinject. CSL Vifor resolved that inquiry in 2024 by committing to a marketing campaign addressing the regulator's anticompetitive concerns.