Biosimilars Face High Expectations, But Also Barriers to Acceptance

Practitioners should expect that payers will mandate multiple switches to biosimilar tumor necrosis factor inhibitors (anti-TNFs) due to the cost benefits of these therapies, which so far appear to yield similar efficacy and safety outcomes to originator anti-TNFs, said Alan Moss, MD, at the virtual 2020 Advances in Inflammatory Bowel Disease (AIBD) meeting.

Alan C. Moss MD, is the director of the Crohn’s and Colitis Program at Boston Medical Center and associate professor of medicine at Harvard Medical School in Cambridge, Massachusetts.

Dr Moss said that longitudinal follow-up will be the key to identifying any novel issues with biosimilars in the treatment of Crohn disease and ulcerative colitis. He explained while biosimilars have structural differences from reference medications, they do not appear to have lesser potency. He cited a study that found “no notable differences in the efficacy, pharmacokinetics, pharmacodynamics, safety, or immunogenicity of IFX-dyyb and infliximab” when the biosimilar was used to treat active Crohn disease. The Nor-Switch study done in Norway showed that patients who achieved remission on the reference medication and switched to a biosimilar, followed over 52 weeks, had no worsening of disease. When these patients were followed for 78 weeks they showed no significant difference in disease activity, fecal calprotectin or trough levels.

Some physicians and patients may have concerns about substituting biosimilars for reference medications, Moss noted. Some people question the ethics of switching therapeutics for patients who have achieved remission or low disease activity with the reference drug for purposes of cost only. Among patients, the potential exists for the “nocebo effect,” in which patients expect poor results from a biosimilar and as a result do not achieve the response that should be seen.

Dr Moss also referenced the “unknown knowns” of biosimilars, including the long-term immunogenicity of biosimilars vs reference therapeutics; whether biosimilars will yield comparable mucosal healing rates in inflammatory bowel disease as reference medications; the possibility of a “drift” in quality with manufacturing changes; and tracking at the pharmacy level. 


—Rebecca Mashaw



Moss AC. Biosimilars: positioning in IBD as first-line or switch therapy. Talk presented at: Advances in Inflammatory Bowel Disease 2020 regional meeting; June 27, 2020; virtual.