Canadian Gastroenterology Groups Issue Joint Position That Takes Aim at Nonmedical Switching

The Canadian Association of Gastroenterology and Crohn’s and Colitis Canada this week announced a joint statement on biosimilars in the treatment of inflammatory bowel disease (IBD). The paper, which is slated to appear in the Journal of the Canadian Association of Gastroenterology, recommends that patients stable on biologic treatment should not be subject to nonmedical switching, and recommends against automatic substitution of biosimilars for their references.

Crohn’s and Colitis Canada’s president and chief executive officer, Mina Mawani, said in a statement announcing the position that “Opposition to a non-medical switch policy affecting patients with Crohn’s and colitis has been irresponsibly characterized as an emotional reaction to change. This work invalidates this portrayal and firmly indicates to policy makers that non-medical switch is not in the best interest of patients as this may result in worsening of disease in some patients.”

In the prepublication version of the paper made available by the organizations, the authors use a Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to rate the quality of evidence and the strength of recommendations. They focused on randomized controlled trials (RCTs) and cohort studies comparing biosimilars with originator products in IBD.

According to the authors, after assessing 1 RCT, the PLANETCD study, and 1 cohort study, a French equivalence study, the quality of evidence for using biosimilar infliximab in new patients with Crohn disease (CD) is low, according to GRADE, and the quality of evidence for doing so in new patients with ulcerative colitis (UC) is very low; the authors call for more RCTs. These evaluations led to a weak recommendation to use a biosimilar in new starts, but “If the price differential is modest, then the infliximab originator should be used.”

With respect to nonmedical switching, the authors say that 2 RCTs (the NOR-SWITCH study and a German switch study presented in abstract form at a 2018 meeting) in patients with IBD and 2 cohort studies (one published in abstract form in Inflammatory Bowel Diseases and the other from an Australian study presented in abstract form at a 2019 meeting), provided very low-quality evidence “against switching from originator infliximab to CT-P13 in IBD patients who are doing well on the original drug.” These evaluations led to a weak recommendation against nonmedical switching; the authors write that “data suggest that switching in this setting leads to an increased risk of worsening of disease, dose escalation and/or switching to an alternative therapy.” They add that “We do not recommend automatic substitution of biologic with a biosimilar in IBD patients given the paucity of evidence for the efficacy and safety of this approach.”

News of the upcoming publication of the position statement comes as other Canadian organizations are taking steps to reassure patients of the safety and efficacy of biosimilars. The Canadian Digestive Health Foundation, for one, has begun offering webinars for patients to discuss transitioning to biosimilars. The webinars have focused on Health Canada’s stance on biosimilars, clinical evidence of safety and efficacy, and the experiences of patients who have successfully switched. The organization has also issued a brochure for patients that explains how transitioning to a biosimilar takes place.