There is a Canadian plan to switched at least 26,000 patients, including those being treated with infliximab for ulcerative colitis and Crohn's disease, from biological therapies (etanercept, infliximab, insulin glargine, filgrastim, pegfilgrastim, glatiramer) to biosimilars, with estimated saving of CAN$227-380 million over the next four years.
In November 2019, the Canadian Association of Gastroenterology and Crohn’s and Colitis Canada issued a joint position paper recommending against “nonmedical switching from originator infliximab to biosimilar in patients who have stable irritable bowel disease and are doing well on the original product”. This statement was based on the evaluation of the direct and indirect costs, logistic hurdles linked with the low number of infusion centres in the region, and clinical issues including the potential increase of disease-related surgeries and for disruption and delay in access to care as well as the non-medical switch from biologics to biosimilars.
In Europe, the European Medicines Agency has referred switching decisions to each member state and they have agreed that no further clinical studies are required. Not all European countries have released specific regulations, although switching to equivalent biosimilars is encouraged. Collaborative switching programmes should be implemented that can provide the patients with adequate information/
The authors conclude that “only real-world experience will tell us the effects of non-medical switching to biosimilars”.