Although 75% of gastroenterologists believed that the efficacy of biosimilars and biologics were the same, most clinicians still preferred the brand-name drug option.
Although most Israeli gastroenterologists do not have concerns about the safety and efficacy of biosimilars, most clinicians still preferred the brand-name drug option, particularly regarding adalimumab, according to a study published in Medicina.1 Physicians are most opposed to switching to biosimilars in pregnant patients and those who have had difficulty achieving remission.
Biosimilars for inflammatory bowel disease (IBD) have been available in Europe since 2013, and the United States and Israel since 2016. They have been used to treat conditions including gastroenterology, oncology, immunology, hematology, and inflammatory diseases.2
“There is still insufficient evidence and a lack of clear guidelines regarding the preference of one drug over the other and regarding the replacement of the original drug with a biosimilar during treatment,” a team of Israeli investigators stated. “Many questions remain. Until enough evidence has accumulated from head-to-head comparisons, and until clear guidelines on the subject emerge, we decided to investigate the perception of Israeli gastroenterologists prescribing these drugs.”
A cross-sectional, 20-question survey was conducted among members of the Israeli Gastroenterology Association (IGA) between March and May 2022 regarding the prevalence of biosimilar uptake. The survey, sent via email, included questions about the decision to start a new biological treatment, switching between the originator and biosimilar, the clinician’s personal experience with biologic treatments, and demographic data, such as age, gender, and job position.
Of the 356 eligible gastroenterologists, 108 completed the questionnaire. The mean age was 47.6 years, 65% were men, 63% had more than 10 years of profession experience, and 45% worked in a hospital only. On average, physicians were treating 24 patients with IBD per month with biologics.
When asked about safety concerns, the average response was 2 on a scale in which 1 represented “not concerned” and 5 represented “concerned very much.” In total, 62% prescribed biosimilars to patients in the past year. Most (81%) of patients were biologically naïve and only 19% were switched to a biosimilar. When surveyed, 75% of gastroenterologists believed that the efficacy of biosimilars and biologics were the same. Thirteen percent believed that the originator was more effective, 2% thought the biosimilar was more effective, and 10% did not know.
When beginning a new biologic drug with no binding guidelines, over half (58%) of gastroenterologists preferred the brand-name infliximab and 67% preferred the brand-name adalimumab.
According to physicians, resistance to switching occurred in 19% of patients in remission over 2 years, 36% of pregnant women, 29% with active disease, and 70% of those with difficulty achieving remission. When a lack of response after switching occurred, most (78%) gastroenterologists decided to change the mechanism of action instead of returning to the brand-name drug (21%).
The patient’s perspective regarding changing the drug to a biosimilar was rated 4.1 on average. The statement that there is enough information on biosimilars available from randomized controlled trials was rated a 3.3, and the desire to learn about biological drugs from reliable sources was rated a 4.0.
Investigators believed a strength of the study was the range of gastroenterologists across Israel that participated in the survey. However, the validity of the questionnaire remains uncertain. Further, they were unable to determine why some eligible doctors chose not to participate.
“With the rapidly gained momentum of biosimilars and the expected introduction of more biosimilars to the IBD field in the coming years, studies such as this one are very valuable,” investigators concluded. “Its utility is in both directing the coming studies to answer unsolved questions and in guiding the delivery of special educational knowledge to IBD practicing physicians to relieve their concerns.”