Academic oncology clinicians’ understanding of biosimilars and information needed before prescribing

Abstract

Background:With increasing numbers of oncology biosimilars in the approval pipeline, it is important to investigate oncology clinicians’ understanding of biosimilars and what information they need prior to adoption.Methods:Between January and May 2018, 77 oncology clinicians (52 physicians, 16 pharmacists, and 9 advanced practice providers) completed a survey covering three domains: clinician understanding, prescription preferences, and patient involvement. An in-depth interview was designed based on themes identified in the first 50 surveys: cost, safety and efficacy, patient preference, and disease stage. Participants were chosen to participate in the interview based on outlying responses to survey questions.Results:When asked to define a biosimilar, 74% (57/77) of respondents could not give a satisfactory definition, and 40.3% (31/77) considered a biosimilar the same as a generic drug. The most important factor in biosimilar prescription was safety and efficacy (4.51 out of 5) followed closely by cost differences (4.34 out of 5). A 40% increase (53.2–94.8%) in clinicians’ prescribing likelihood was seen after a biosimilar is designated as interchangeable. Participants in this study were split regarding the importance of shared decision-making with patients [50.7% (39/77) important or extremely important, 39.0% (30/77) somewhat or not at all important]. Clinicians were also split concerning the role that pharmacists should play in the decision to prescribe or substitute biosimilars.Conclusion:Understanding of biosimilars is low, and educational needs are high. The information that clinicians deem important to assess, such as safety, efficacy and cost, will need to be provided before they are comfortable prescribing biosimilars.

Clinical and Regulatory Concerns of Biosimilars: A Review of Literature

“…After screening for eligibility, we included 16 studies in the analysis ( Table 2 ) [ 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 ]. The included studies were from Europe, UK, United States, Australia, Asia, and Africa [ 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 ]. The targeted healthcare professionals were: clinicians, GPs, pharmacists, nurses, consultants, care managers, and specialists in clinical settings where biologics are more involved such as oncology, rheumatology, endocrinology, gastroenterology, dermatology, nephrology, and hematology.…”

“…Cook et al reported that 74% of academic oncology clinicians did not know the basic definition of biosimilars and 40.3% of them considered biosimilars and generics as the same molecules [ 30 ]. In Park et al’s survey, 66.2% of Asian gastroenterologists knew the basic concepts of biosimilars, but only 6% of them felt confident to use biosimilar monoclonal antibodies [ 31 ].…”

“…If the FDA designated the biosimilar as an interchangeable medicine, 94.8% of academic oncology clinicians in Cook et al’s study would prescribe a biosimilar interchangeably with its originator [ 30 ]. In Park et al, 86.7% of Asian gastroenterologists were against automatic substitution at the pharmacy level [ 31 ].…”

Physicians’ Knowledge and Awareness about Biosimilars in Saudi Arabia: What is Imperative to Know ??

“…3 Indeed, before the actual prescribing of biosimilars, it is of utmost importance to know the efficacy, safety, cost, stability and appropriateness of biosimilars. [3][4][5] On the other hand, around 52.4% of the studied physicians believed that information regarding the acquisition of cost-differences is important to consider while using biosimilars. This study results were similar to another study which reported that around 86% of the participants were in favor of acquiring more information regarding cost differences between the reference drugs and biosimilars.…”

“…Biosimilars are quite effective among patients with chronic and severe diseases and in those patients who have failed to respond to earlier medications. 5,6 European Medicines Agency (EMA) stated that the biosimilarity profile of biosimilars in terms of efficacy and safety were quite high when compared with their therapeutic drugs. On the other side, a few healthcare organizations (HCOs) believed that biosimilars were complex proteins and could never be identical similar of the therapeutics agents.…”