On April 27th, the journal Digesitve Diseases and Sciences published a editorial by Frank I. Scott, MD entitled “Infliximab Versus Biosimilars for IBD: Is It Better to Fight Than Switch?. Dr. Scott heads the Crohn’s and Colitis Center, Division of Gastroenterology and Hepatology, Department of Medicine, at the University of Colorado.
In the editorial, Dr. Scott discusses a study appearing in the April issue of Digestive Diseases and Sciences which presents the most comprehensive review to date of data supporting non-medical switching between infliximab and CT-P13 (marketed as Inflectra).
Forty-nine randomized controlled trials, observational studies, and conference abstracts were included in the authors’ review. Of these, only three of the reviewed studies were randomized controlled trials, including NOR-SWITCH and two as-yet-unpublished IBD-specific trials. From the article:
Collectively, these studies demonstrated no significant difference in sustained clinical response between bio-originator infliximab and its biosimilars.
Despite these reassurances, significant questions remain regarding the long-term safety of non-medical switching strategies. While the summarized data in their review, for the most part, suggest that switching between bio-originator infliximab and CT-P13 is safe, the data quality is limited. As noted previously, only one randomized controlled trial has been published, with two additional studies included which are pending publication. Significant heterogeneity among existing observational studies limits their interpretation as well. Further, while non-medical switching policies have been enacted, there has been incomplete pharmacovigilance reporting on the patient level and pharmacoepidemiologic evaluation at the population level. Lastly, since the available data pertain to single switches from originator compound to CT-P13, they incompletely reflect the multi-directional switching that may occur in practice with non-medical switching.\
Unfortunately, loss of response to therapies in both CD and UC is well described, obscuring the differentiation of loss of response due to expected rates versus that which can be attributed to the switch itself. Accurately measuring this risk will be vital in considering the true medical, ethical, and financial burdens related to non-medical switching. Further, it is unlikely that such risk–benefit balances are identical across different biologics, as accumulating data suggest that specific agents are preferable in UC versus CD and vice versa.
In conclusion, the review by [the authors] summarizes the current state of the evidence with regards to non-medical switching for bio-originator infliximab and CT-P13. While the totality of evidence appears reassuring, significant questions remain regarding the quality of and comparability of these data. Further prospective research is required before non-medical switching can be widely adopted, and long-term observation is requisite when it does occur to ensure the safety and effectiveness of such strategies.