Big Molecule Watch
December 14, 2016

European Crohn’s and Colitis Organisation Supports Switch to Biosimilars

The European Crohn’s and Colitis Organisation (“ECCO”) released a statement last week supporting the switch from the reference infliximab to biosimilar infliximab in patients with inflammatory bowel disease (“IBD”).  ECCO’s new position is particularly significant, given its earlier position taking a cautious approach to biosimilars and suggesting that “rigorous testing [of biosimilars] is necessary in patients with IBD to ensure that appropriate efficacy and safety standards are met.”

ECCO’s new position statement relied on recent studies of infliximab in IBD patients, including the NOR-SWITCH study sponsored by the Norwegian government, which compared Johnson & Johnson’s Remicade (infliximab) to Celltrion’s approved biosimilar Remsima.  On the basis of these studies, as well as a “better understanding” of the regulatory process for biosimilars, ECCO made the following statements, among others:

  • “When a biosimilar product is registered in the EU, it is considered to be as efficacious as the reference product when used in accordance with the information provided in the Summery of Product Characteristics.”
  • “Switching from the originator to a biosimilar in patients with IBD is acceptable.”
  • “Switching from originator to a biosimilar should be performed following appropriate discussion between physicians, nurses, pharmacists, and patients, and according to national recommendation.”

According to its website, ECCO is a non-profit organization that was founded in 2001 with the mission of improving the care of patients with IBD in Europe.  ECCO is comprised of 36 member states as well as individual members throughout Europe.