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NOR-SWITCH Shows That Switching Infliximab Biosimilar Is Safe
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.
Biosimilars Gastroenterology Roundup: March 2025
April 1st 2025As the biosimilar industry celebrates a decade of growth, the market continues to evolve with expanded treatment options, cost savings, and a flurry of new competitors—yet regulatory challenges, market dynamics, and patient accessibility remain key hurdles to unlocking its full potential.
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
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PBM Evolution Toward Value-Based Care Shifts to Transparent Pharmacy Pricing
March 30th 2025Josh Canavan, PharmD, RazorMetrics, and Chris O'Dell, Turquoise Health, predict pharmacy benefit managers (PBMs) will evolve toward value-based care, mirroring the broader shift toward open-cost structures.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
