Switching from infliximab to biosimilar may be safe and effective

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  • CT-P13 demonstrated noninferiority in NOR-SWITCH, a switching study from infliximab, but remains unstudied for individual indications or multiple switches.

Why this matters

  • TNF inhibitors such as infliximab are effective in a range of autoimmune diseases, but are expensive.
  • The biosimilar drug CT-P13 may offer a more affordable alternative.
  • It was FDA-approved in 2016 for 6 indications despite not being studied individually for each.
  • Switching from infliximab is controversial—in part because of concerns about anti-drug antibodies—and few data exist.

Key results

  • Disease worsening occurred in 53 (26%) patients in infliximab group vs 61 (30%) patients in CT-P13 group.
  • −4.4% adjusted risk difference (95% CI, −12.7% to 3.9%) within noninferiority margin.
  • Adverse event rates similar between groups.

Study design

  • Randomized, noninferiority, double-blind, parallel-group, multicenter comparative phase 4...