The European Commission (EC) has accepted Vifor’s legally binding commitments under EU antitrust rules. The commitments address the Commission’s competition concerns relating to Vifor’s potential disparagement of Monofer, the closest—and potentially only—competitor of Vifor’s flagship intravenous iron medicine in Europe, Ferinject.
“Iron deficiency is a condition affecting millions of people across Europe. Access to safe, effective, and affordable medicines is therefore essential. Vifor has committed to undo the effects of its potentially misleading communications on the safety of the closest competing medicine for intravenous iron treatment. Today’s decision makes these commitments legally binding on Vifor and re-establishes a level playing field to benefit consumers,” Margrethe Vestager, Executive Vice-President in charge of competition policy.
Iron is essential for healthy red blood cells that carry oxygen. Iron deficiency is common, especially among women and individuals with chronic diseases or blood loss. Severe deficiency can lead to serious complications. Vifor Pharma’s Ferinject and Pharmacosmos’ Monofer are high-dose intravenous iron medications used when oral treatments are ineffective.
The European Commission began an antitrust investigation into Vifor’s conduct following a complaint filed by Pharmacosmos in June 2022. EC preliminarily found that Vifor may have limited competition in several national markets for intravenous iron medicines, including Austria, Finland, Germany, Ireland, Portugal, Romania, Spain, Sweden, and the Netherlands, by potentially disseminating misleading information about the safety of a competing product. This behaviour could constitute an abuse of the dominant position, violating European Union competition laws.
Vifor has committed to rectifying potentially misleading messages about Monofer’s safety by launching a communication campaign. They will also implement measures to ensure compliance, including internal mechanisms and annual staff training.
In a statement to Fierce Pharma, CSL Vifor said it is “grateful for the constructive discussions with the EC” but stressed that the commitments were offered without any admission of liability or wrongdoing. In late 2021, CSL Limited acquired Vifor Pharma for $11.7 billion.
The Commission has determined that Vifor’s final commitments would address its competition concerns regarding Monofer’s potential disparagement. As a result, the Commission has decided to bind Vifor to these commitments legally. Vifor will appoint a monitoring trustee to oversee the implementation of these commitments, which will be in effect for ten years.
