Uncovering oncologists’ gaps and attitudes toward biosimilars: Impact of a two-phase educational program.

91 Background: Biosimilar agents are changing the clinical landscape in oncology. We sought to measure oncologists’ competence and knowledge of biosimilars and to address identified educational gaps related to biosimilars’ clinical application. Methods: We designed a 2-phase online educational program focused on biosimilars that included questions to measure oncologists’ knowledge and competence. These questions were administered before and then repeated after the education was delivered. Oncologists were also invited to submit their own questions about biosimilars and their use in clinical practice. To uncover key educational gaps, we identified questions with high incorrect responses at baseline, persistence of incorrect responses, and questions submitted by learners during Phase 1 of the education. These gaps were used to refine the teaching in Phase 2 of the education. Results: Between March and December 2017, a total of 1616 oncologists participated in the education. Among the subset of oncologists who answered at least 1 question, we identified persistent misunderstandings about biosimilars at baseline: 59% incorrectly believed a biosimilar could have efficacy that differs from its reference agent; a further 15% were unsure (n = 238) Absolute improvement in optimal response was 19% over baseline ( P = .0002) after Phase 1 of the education and 42% ( P < .0001) after Phase 2 66% did not understand that, in the US, biosimilars cannot be substituted at the pharmacy without the prescriber’s approval (n = 220) Absolute improvement in optimal response was 13% over baseline ( P = .0571) after Phase 1 of the education and 33% ( P < .0001) after Phase 2 82% did not understand extrapolation of indications among biosimilars (n = 114) Absolute improvement in optimal response was 41% over baseline ( P < .0001) after the education Oncologists’ willingness to prescribe biosimilars also increased. Conclusions: We uncovered gaps in oncologists’ understanding of the efficacy, substitution, and indications of biosimilars, which may explain some oncologists’ reluctance to consider biosimilars as a treatment option for their patients. This educational program increased oncologists’ competence with biosimilars.

BIOSIMILARS IN INFLAMMATORY BOWEL DISEASES: an important moment for Brazilian gastroenterologists

ABSTRACT Biosimilars are not generic drugs. These are more complex medications than small molecules, with identical chemical structures of monoclonal antibodies that lost their patency over time. Besides identical to the original product at the end, the process of achieving its final forms differs from the one used in the reference products. These differences in the formulation process can alter final outcomes such as safety and efficacy of the drugs. Recently, a biosimilar of Infliximab was approved in some countries, even to the management of inflammatory bowel diseases. However, this decision was based on studies performed in rheumatologic conditions such as rheumatoid arthritis and ankylosing spondylitis. Extrapolation of the indications from rheumatologic conditions was done for Crohn’s disease and ulcerative colitis based on these studies. In this article, the authors explain possible different mechanisms in the pathogenesis between rheumatologic conditions and inflammatory bowel diseases, that can lead to different actions of the medications in different diseases. The authors also alert the gastroenterological community for the problem of extrapolation of indications, and explain in full details the reasons for being care with the use of biosimilars in inflammatory bowel diseases without specific data from trials performed in this scenario.