Patients Feel Uneasy Around Biosimilar Use in IBD, More Education on Biosimilars Needed

Credit: ResearchGate

A new study suggested that, despite biosimilar drugs being just as safe as originator drugs—and more cost-friendly—patients feel tense about getting prescribed biosimilars, and the study reveals there is a lack of biosimilar awareness.¹

The study, led by Ferdinando D’Amico, MD, of Vita-Salute San Raffaele University in Milan, Italy, as well as from the department of biomedical sciences at Humanitas University, found out that gastroenterologists know very little about biosimilars in terms of their effectiveness, safety, and the complexity of the reverse and multiple switches. Since gastroenterologists don’t know enough about the effectiveness and safeness of biosimilar use and how it could treat inflammatory bowel disease (IBD), the knowledge about the drug may not be communicated enough to patients.

A 2017 survey confirmed practitioners’ lack of knowledge about biosimilars. International physicians from many specialties, including gastroenterology, completed the survey.

The survey revealed “specific knowledge gaps related to biosimilars,” such as the struggle to correctly define terms like extrapolation and interchangeability. Many also had a difficult time to articulate the difference between biosimilars and originators. Because of the lack of knowledge, the investigators wanted to learn gastroenterologists’ attitude toward biosimilars and how they go about prescribing these drugs.

The team designed a cross-sectional study targeted at clinicians worldwide who work with patients with IBD. Clinicians completed the survey from January 2023 – February 2023. The survey had 46 questions, which addressed demographics; specialty; level of experience; practices and attitudes toward biosimilar use; interchangeability including reverse and multiple switches; nocebo effect and non-medical switch; and current and future perspectives.

The survey only mandated the demographic questions—participants could choose not to fill out questions in other categories. Because of this, the team reported the number of respondents who answered each question.

A total of 234 physicians from 38 countries responded to the survey. A good percentage of the respondents (86%) were gastroenterologists, 2.5% were surgeons, and the rest of the respondents were internal medicine specialists and general practitioners.

Most participants (74.4%) worked >10 years in the field of IBD, making them highly experienced. About the same percentage of participants worked in hospitals caring for >500 IBD patients a year (37.1%) and institutions caring for 100-500 patients (38.5%). Only 24.3% of participants worked in centers with <100 patients.

The survey revealed 83.3% of participants believe biosimilars are just as effective and safe as originator drugs. Only 3.9% believed that biosimilars are less effective and safe.

Most of the participants rated their overall confidence with biosimilars as moderate, which is roughly 8.5 on a scale from 0 – 10. While clinicians gave biosimilars a moderate score, they rated their patients’ average rating of confidence as only 7.7.

A great number of practitioners (83.3%) reported that patients should be told what a biosimilar is before they are switched over—and 70% of clinicians reported that they already explain what a biosimilar or originator drug is to their patient.

Back in 2022, Joel M. Gelfand, MD, of Penn Medicine, told HCPLive how he goes about explaining biosimilars to patients, telling them it’s “good news” and the drugs have been “carefully tested and studied at a number of levels.”²

Furthermore, in the survey, nearly half of the practitioners had patients who refused to switch over to biosimilars, but of their patients, only 5% of their patients refused. Yet, safety (7.8%) was not a main source of fear for patients—fear stemmed from biosimilars’ lower effectiveness (36.2%) and disease flares (23.8%).¹

“Patients who have responded to originator drugs may fear losing their response and, consequently, may experience the nocebo effect,” the team wrote. “To overcome this limitation, providing adequate patient information is essential and has been associated with significant improvements in patient outcomes.”

For nocebo effects, 86.4% of the physicians knew what the term referred to but roughly one-third could not say whether their patients experienced this.

According to the survey, patients fear lower effectiveness and disease flares because of low knowledge on biosimilars. Some (17.4%) believe there are little data available on biosimilars and 11.9% of the respondents did not have access to biosimilars in their hospital.

People may choose to switch from a biosimilar to an originator because of biosimilar unavailability (37% of participants), the loss of response to a biosimilar (27.8%) and an allergic reaction to the biosimilar (14.8%).

Over half of the participants (50.5%) switched from one biosimilar to another because of biosimilar unavailability, allergic reactions, and a lack of a response.

“Interestingly, approximately three-quarters of patients who lost their response after switching to a biosimilar regained their response after reverse switching to an originator,” investigators wrote. “This observation is intriguing and suggests that there may be situations where this strategy could be considered.”

Ultimately, while 52.2% of physicians believed they would soon prescribe the biosimilars of vedolizumab and ustekinumab, 30.4% said the availability of vendolizumab and ustekinumab would not make a difference to the treatment for IBD patients.

References

1. ^{D’Amico F, Solitano V, Magro F, Olivera PA, Halfvarson J, Rubin D, Dignass A, Al Awadhi S, Kobayashi T, Queiroz NSF, et al. Practical Management of Biosimilar Use in Inflammatory Bowel Disease (IBD): A Global Survey and an International Delphi Consensus. Journal of Clinical Medicine. 2023; 12(19):6350. https://doi.org/10.3390/jcm12196350}
2. ^{Addressing Patients’ Concerns with Biosimilars. HCPLive. Assessed October 17, 2023. https://www.hcplive.com/view/addressing-patients-concerns-with-biosimilars}