NOR-SWITCH Shows That Switching Infliximab Biosimilar Is Safe

Stanton R. Mehr

A study from Norway on whether switching stable patients with rheumatoid arthritis (RA) treated with Remicade® to a biosimilar has revealed that outcomes were no different.

A study from Norway on whether switching stable patients with rheumatoid arthritis (RA) treated with Remicade® to a biosimilar has revealed that outcomes were no different.

The results of the NOR-SWITCH trial were announced at the United European Gastroenterology Week in Vienna, Austria, on October 18. This investigation was designed to determine how switching to Celltrion’s biosimilar (marketed as Remsima® in Europe and soon to be marketed as Inflectra® in the US) would affect patient status. This 2-year, post marketing study was designed to demonstrate noninferiority (not superiority) of Remsima to Remicade.

The approximately 500 patients entering the trial had to be receiving a stable dose of infliximab for at least 6 months at baseline. In this controlled study, half of the patients were switched to Remsima treatment. The results indicated no clinically meaningful difference in safety or efficacy. Although this trial was not designed to demonstrate the possible effects of switching back to the original product, it does bolster the case that in patients with RA, switching from Remicade to the biosimilar poses little risk.

What of switching these products in patients with other approved indications?

More data are needed to determine the effectiveness and safety of this option. In one study conducted by Celltrion’s marketing partner Pfizer, 3300 patients are being recruited to determine how often patients with inflammatory bowel disease switch from one anti-TNF to another. That study is due to end in June 2019. Will NOR-SWITCH spur US payers to encourage physicians to switch treatments, once Inflectra is launched in late November? It does offer a bit of insulation for proponents, but (1) only for Inflectra/Remsima—Remicade switches in RA not for other indications, and (2) these study results do not apply to other anti-TNFs.

However, Sandoz utilized a multiple-switching study design in one of the studies (Study 302) to support FDA approval of its etanercept biosimilar Erelzi™. In this study of plaque psoriasis, a subgroup of patients were switched between the originator product and Erelzi at weeks 12, 18, and 24, without negative effects.