In a recent statement published in the Journal of Crohn’s and Colitis, the European Crohn’s and Colitis Organization (ECCO) announced its support for switching from an originator product to a biosimilar in patients with inflammatory bowel disease (IBD).
In its position statement, ECCO asserts that switching from the originator to a biosimilar in patients with IBD is acceptable if it is in line with national recommendations and has been discussed among the physician, nurse, pharmacist, and patient. This view, which represents a change from ECCO’s previous position, is based on the clinical experience gained from investigational studies and postmarketing trials using the biosimilar version of infliximab.
Lead author and President Elect of ECCO, Silvio Danese, MD, said, “Findings from the 2015 ECCO survey of IBD specialists found that around 80% of specialists are either totally confident, very confident or confident enough in using biosimilars, which is a huge change compared to 39% when a similar survey was conducted back in 2013.”
As for all biologics, traceability should be based on a robust pharmacovigilance system. The authors also noted that several postmarketing studies are ongoing or near publication, which lends further support to the improved confidence in the safety and efficacy of the biosimilar (Celltrion’s Remsima®, which is marketed in the US as Inflectra®).
This marks a significant shift in attitude from the previous ECCO position paper, which advised that switching from an established biologic to a biosimilar was inappropriate and called for more data on the safety and benefit of biosimilars in general.
Dr. Danese and his colleagues concluded, “there have been no reports so far that switching from the reference to the biosimilar infliximab [Remsima] has caused problems, in either adult or pediatric IBD patients. On the contrary, an increasing number of publications have shown that there are no safety or efficacy concerns about switching.”
