A Japanese postmarketing surveillance study of biosimilar infliximab CT-P13 (Inflectra, Remsima) concludes that the biosimilar and its reference, Remicade, are comparable in terms of efficacy and adverse drug reactions in patients with inflammatory bowel disease (IBD) and that the biosimilar is a cost-efficient option that is interchangeable with the reference in real-world practice.
A Japanese postmarketing surveillance study of biosimilar infliximab CT-P13 (Inflectra, Remsima) concludes that the biosimilar and its reference, Remicade, are comparable in terms of efficacy and adverse drug reactions (ADRs) in patients with inflammatory bowel disease (IBD) and that the biosimilar is a cost-efficient option that is interchangeable with the reference in real-world practice.
It should be noted that, while interchangeability is a matter of law in the United States, it is treated as a medical matter in other territories; in the United States, the FDA may grant a designation of interchangeability that allows a biosimilar to be substituted at the pharmacy level for its reference. In other territories, interchangeability is understood to be a product characteristic that allows one medicine to be exchanged for another while producing the same clinical effect.
The current study enrolled 700 patients, and in this interim analysis, data for 523 patients (267 of whom had Crohn disease [CD] and 256 of whom had ulcerative colitis [UC]) were evaluated for safety and efficacy.
Patients were either subject to a nonmedical switch to CT-P13 (142 in the CD group and 77 in the UC group), subject to a medical switch after a loss of response to another agent or when restarting therapy after a prior discontinuation (80 in the CD group and 40 in the UC group), or initiating their anti—tumor necrosis factor therapy with CT-P13 (78 in the CD group and 139 in the UC group).
In total, 144 ADRs were reported in 106 patients. The most common ADR was infusion reaction, reported in 49 patients. A history of drug allergies was the most significant risk factor for infusion reactions. There were 29 serious ADRs in 22 patients, and 1 death due to retroperitoneal hemorrhage and pneumonia.
In patients who switched for nonmedical reasons, Crohn Disease Activity Index and partial Mayo scores that were lowered with previous treatment were maintained after the switch. In patients initiating treatment with CT-P13, disease activity scores dropped by week 2, and scores remained in “low ranges thereafter.” In patients subject to a medical switch, “the efficacy rate assessed by physicians increased and remained above 80%.”
This interim analysis, write the authors, shows that the incidence and type of ADRs experienced with CT-P13 are similar to those seen with the reference and that the biosimilar was effective in treating biologic-naïve patients as well as those switched for nonmedical reasons. In those switched to the biosimilar for medical reasons, treatment continuation did not differ significantly from continuation in the naïve group.
“These results showed that CT-P13 is a useful, cost-efficient biosimilar that is comparable to and interchangeable with the originator [infliximab] in patients with IBD,” the authors conclude.
Nakagawa T, Kobayashi T, Nishikawa K, et al. Infliximab biosimilar CT-P13 is interchangeable with its originator for patients with inflammatory bowel disease in real world practice [published online August 23, 2019]. Intest Res. doi: 10.5217/ir.2019.00030.