(Finance) – The European Commission invited operators to comment on the commitments offered by Vifora leader in iron deficiency therapies, to address competition concerns related to alleged denigration of its closest competing treatment – and potentially unique – in Europe for the treatment of intravenous iron, Monofer by Pharmacosmos.
Following the opening of aformal investigation In June 2022, the Commission preliminarily established that Vifor is dominant in several national markets for the supply of intravenous iron medicines, namely in Austria, Finland, Germany, Ireland, Portugal, Romania, Spain, Sweden, France and Holland. The Commission is concerned that Vifor may have limited competition in the market for intravenous iron treatment illegally denigrating Monoferan iron deficiency treatment from its closest competitor in Europe, Pharmacosmos.
The Commission has indications that for many years Vifor may have spread potentially misleading information on the safety of Monoferro, mainly targeting healthcare professionals, which may have unduly hindered the adoption of Monoferro in the European Economic Area (EEA). Vifor’s conduct appears aimed at hindering competition against its blockbuster high-dose intravenous iron treatment, Ferinject.
To address the Commission’s competition concerns, Vifor offered the following commitments: launch a communication campaign global and multi-channel to rectify and nullify the effects of potentially misleading messages previously disseminated by Vifor regarding the safety of Monofer; for a period of 10 years and throughout the European Economic Area, do not engage in communications external medical and promotional information, in writing or orally, on the safety profile of Monofer using information that is neither based on Monofer’s Summary of Product Characteristics nor derived from randomized, controlled clinical trials; implement a series of measures and safeguards to ensure compliance.