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European Commission Accepts Vifor's Commitments Regarding Messaging Involving Rival's Intravenous Iron Treatment and Closes Competition File

  • 22/07/2024
  • News

The European Commission (the Commission) has ended competition proceedings against Vifor Pharma (Vifor) by accepting commitments which Vifor had presented to address the Commission's concerns relating to Vifor's possible disparagement of Monofer®, a medicine of Pharmacosmos and the closest competitor of Vifor's intravenous iron deficiency treatment, Ferinject® (see, attached press release of today). The Commission had subjected these commitments to a market test in April and May 2024 (see, Van Bael & Bellis Life Sciences News & Insights, 22 April 2024).
 
According to the Commission, the market test caused Vifor to adjust its initially proposed commitments, but the fundamentals of Vifor’s commitments would not seem to have changed: 

  • Vifor will launch a multi-channel communication campaign to rectify possibly misleading messages regarding the safety of Monofer®.
  • Vifor will not engage in external communications regarding the safety profile of Monofer® without relying on that medicine’s Summary of Product Characteristics or on clinical trials that were specifically designed to compare Ferinject® and Monofer®.
  • Vifor will implement measures and safeguards to ensure compliance with these commitments.

A monitoring trustee will oversee Vifor’s compliance with its commitments which will last for 10 years. For its part, the Commission adopted a decision that causes the commitments to be binding on Vifor but does not establish any infringement of the competition rules by Vifor.
 
Vifor still has to deal with a parallel case which the Competition and Markets Authority started in the United Kingdom earlier this year (see, Van Bael & Bellis Life Sciences News & Insights, 1 February 2024) and which has not yet been concluded.

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