Biosimilars are as effective and safe as originator biological therapies for patients with inflammatory bowel disease (IBD), according to new data.
In a systematic review of real-world observational studies that included more than 7000 patients, the proportion of patients with IBD who were in clinical remission did not change significantly after they switched from an originator product to a biosimilar. Other outcomes, such as loss of response and treatment cessation, were similar between patients who switched to a biosimilar and those who continued the originator therapy.
The findings run counter to current clinical guidance in Canada. “Our results are different from those published in this journal in 2019,” wrote Susanna Meade, MD, of the University of British Columbia in Vancouver, and colleagues. They cited the Canadian Association of Gastroenterology and Crohn’s and Colitis Canada joint position statement suggesting that infliximab biosimilar induction should be limited to previously untreated patients. The joint statement acknowledged that it was a weak recommendation “based on low-quality evidence.”
The current findings were published October 25 in Journal of the Canadian Association of Gastroenterology.
Remission Maintained
In 2019, British Columbia became the first Canadian province to mandate biosimilar switching. Alberta, New Brunswick, and Quebec followed suit in 2021; the other provinces and territories are expected to do so by the end of the year. In the provinces that mandated the switch to biosimilars, cost savings were estimated to be $118.9 million in 2020 alone.
But Health Canada’s statement that the authorization of a biosimilar is not a declaration of equivalence has contributed to “concern and skepticism” among clinicians as to how biosimilars would perform in real-world settings in Canada, according to the researchers.
To evaluate the real-world efficacy of infliximab and adalimumab biosimilars, the researchers examined 43 observational studies that included 7462 adult patients with IBD. Their primary outcomes were efficacy and safety for patients who had switched from an originator therapy to a biosimilar. Secondary outcomes included loss of response, treatment persistence, and immunogenicity.
About 75% of patients who received infliximab were in clinical remission when they switched to a biosimilar. The same percentage remained in remission 1 year after the switch, compared with 78% of patients who didn’t switch. Among patients who received adalimumab, 86% were in remission at the time of the switch, and 82% remained in remission 6 months after switching. Results for loss of response, treatment cessation, and serious adverse events were similar between patients who continued the originator product and those who switched.
Controversial Issue
Commenting on the findings for Medscape, Stephen B. Hanauer, MD, professor of medicine at Northwestern University Feinberg School of Medicine in Chicago, said, “This review summarizes 43 individual studies that basically all say the same thing in one aspect or another: that they meet the criteria for biosimilar approval, which means they act just like the originator product.” Hanauer did not participate in the study. “Approved biosimilar infliximab is infliximab, and approved biosimilar adalimumab is adalimumab.”
Dr Stephen Hanauer
“This has remained a somewhat controversial issue in Canada,” said John Marshall, MD, director of gastroenterology at McMaster University in Hamilton, Ontario. “There’s been a lot of variety in opinion about the appropriateness and safety of switching from an innovator biologic to a biosimilar.” Like Hanauer, Marshall did not participate in the study.
This review should allay clinicians’ concerns, Marshall added. “Overall, this review gives reassurance to clinicians that there isn’t a signal for significant loss of response or concern for safety with biosimilar switch. It supports that strategy, which is obviously being implemented across Canada.”
Dr John Marshall
Marshall pointed out that the systematic review drew most of its data from observational studies. Nine of the reviewed studies compared patients who continued taking the originator product with patients who had switched to biosimilars. “Obviously, observational data have their limitations,” he said, “but with that, there’s no signal that switching to a biosimilar is an unsafe practice.”
The data that provided the basis for the 2019 joint position statement were “more limited,” said Marshall. “Since then, there’s been much more observational data that has provided reassurance. It may be that if that group repeated their review with all the data that are now available, they might make a different conclusion.”
Although he knew of no current effort to revise the 2019 statement, Marshall added, “I think all these things need to be revisited over time as more evidence accrues, and this may be a good opportunity to do so.”
The study was conducted without external funding. Hanauer disclosed relationships with AbbVie. Marshall is former editor of Journal of the Canadian Association of Gastroenterology and has disclosed relationships with Allergan/AbbVie, Amgen, AstraZeneca, Ferring, Janssen, Lupin, Organon, Pfizer, Pharmascience, Roche, Shire, Takeda, Viatris, Alimentiv, Bausch, Bristol Myers Squibb, Celltrion, Fresenius Kabi, Lilly, Novartis, Paladin, Qu Biologics, Sandoz, and Teva.
Richard Mark Kirkner is a medical journalist based in the Philadelphia area.
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