Knowledge Of Biosimilars Research Articles

Assessing Knowledge and Attitude of Healthcare Professionals on Biosimilars: A National Survey for Pharmacists and Physicians in Taiwan.

Despite the first approval of biosimilars’ in 2010, biosimilar products usage has remained low in Taiwan. This cross-sectional survey study assessed healthcare professionals’ (HCPs)—hospital pharmacists, oncologists, and rheumatologists—knowledge, and attitudes toward biosimilars. More precisely, their knowledge and attitude towards biosimilars’ current usage and regulations in Taiwan were analyzed. The mean ± standard deviation knowledge score was 2.56 ± 0.86 out of 4 (n = 395), and a difference in knowledge score was determined according to the hospital types (p = 0.004). Rheumatologists possessed significantly higher confidence in their knowledge of biosimilars than other HCPs (p = 0.001). Pharmacists showed the highest acceptance—and rheumatologists the least—for switching patients from reference drugs to biosimilars (p = 0.02). Hospital type was associated with the respondent’s confidence in their knowledge (p = 0.04) and the preference for distinguishable naming of biosimilars (p = 0.007). Their knowledge scores were associated with their confidence in the efficacy and safety of biosimilars (p = 0.02). The study found that the current level of biosimilar knowledge of HCPs in Taiwan is low. The higher the knowledge score, the greater the confidence in biosimilars and the familiarity with relevant regulations.

Knowledge of biosimilars and perceptions of the naming conventions for biosimilar products in clinical practice in the United States

Knowledge of biosimilars and perceptions of the naming conventions for biosimilar products in clinical practice in the United States

The Clinical Implications of Nocebo Effects for Biosimilar Therapy.

Nocebo effects encompass negative responses to inert interventions in the research setting and negative outcomes with active treatments in the clinical research or practice settings, including new or worsening symptoms and adverse events, stemming from patients’ negative expectations and not the pharmacologic action of the treatment itself. Numerous personality, psychosocial, neurobiological, and contextual/environmental factors contribute to the development of nocebo effects, which can impair quality of life and reduce adherence to treatment. Biologics are effective agents widely used in autoimmune disease, but their high cost may limit access for patients. Biosimilar products have gained regulatory approval based on quality, safety, and efficacy comparable to that of originator biologics in rigorous study programs. In this review, we identified gaps in patients’ and healthcare professionals’ awareness, understanding, and perceptions of biosimilars that may result in negative expectations and nocebo effects, and may diminish their acceptance and clinical benefits. We also examined features of nocebo effects with biosimilar treatment that inform research and clinical practices. Namely, when biosimilars are introduced to patients as possible treatment options, we recommend adoption of nocebo-reducing strategies to avoid negative expectations, including delivery of balanced information on risk–benefit profiles, framing information to focus on positive attributes, and promoting shared decision-making processes along with patient empowerment. Healthcare professionals confident in their knowledge of biosimilars and aware of bias-inducing factors may help reduce the risk of nocebo effects and improve patients’ adherence in proposing biosimilars as treatment for autoimmune diseases such as rheumatoid arthritis and inflammatory bowel disease.

Barriers towards effective pharmacovigilance systems of biosimilars in rheumatology: A Latin American survey

PurposeThis review summarises the current status of regulatory guidelines for the approval of biosimilars in Latin America and highlights the main barriers to effective pharmacovigilance in this region. We also report results from a survey of Latin American rheumatologists assessing their understanding of prescribing biosimilars and the pharmacovigilance of these drugs.MethodsWe reviewed the current guidelines for the regulatory approval of biosimilars and barriers to effective pharmacovigilance in Latin American countries. Rheumatologists attending the II Pan‐American League of Rheumatology Associations PANLAR Review Course (Biosimilars update) in Lima, Peru were asked to complete a short survey to determine their knowledge of biosimilars.ResultsMany Latin American countries continue to lag behind Europe and the United States in establishing regulatory guidance and effective pharmacovigilance systems for biosimilars. Results from our survey also highlight a lack of awareness regarding the availability of biosimilars, their nomenclature, automatic substitution, and reporting adverse drug reactions because of these drugs.ConclusionsThe main barriers to effective pharmacovigilance in Latin America are the lack of consensus on the interchangeability of reference biologics and biosimilars, and the need for more suitably trained personnel to carry out effective postmarketing pharmacovigilance of biosimilars. Inconsistencies in biosimilar nomenclature make it difficult to adequately trace drugs and record adverse drug reactions associated with their use, creating a barrier to the global pharmacovigilance of biologics.

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.

Biosimilar Knowledge Among Oncology/Hematology Team Members in Colorado, USA: An Educational Initiative and Follow-Up Survey.

No data exist regarding oncology/hematology team members' knowledge of and views on biosimilars in Colorado, USA. Published research has suggested that health professionals may have a poor understanding of many issues related to biosimilars. Our goal was to increase oncology/hematology team members' knowledge of biosimilars and then use an anonymous online survey to assess the knowledge gained. We also aimed to examine oncology/hematology team members' overall interest in the subject and their motivation to learn more about biosimilars in the future. In phase I of the project, we developed printed materials covering many topics related to biosimilars, such as definition, regulation, and interchangeability, and the potential of biosimilars in optimal combination therapy for cancer. We distributed our brochures to each participating oncology/hematology office in Colorado. The oncology/hematology team members were then asked to complete the survey. A total of 62 team members responded to our survey. Nearly three-quarters of participants were oncology nurses or oncology nurse practitioners. More than 90% of survey respondents identified correct answers about the definition, regulations, interchangeability, safety, cost issues, and use of biosimilars in oncology and in older patients with cancer. Overall, and compared with those who had low levels of interest and motivation, significantly more (p < 0.05) study participants were interested in the subject of biosimilars [57 (92%) vs. 5 (8%)], motivated to learn more about them [59 (95%) vs. 3 (5%)], and interested in sharing information about biosimilars with colleagues and patients [51 (82%) vs. 11 (18%)]. Our results demonstrate that oncology/hematology team members participating in our study became familiar with many important issues related to biosimilars. Many survey respondents were highly motivated to participate in future training focused on biosimilars, which should pave the way for new educational projects in the area.

Patient attitudes and understanding about biosimilars: an international cross-sectional survey.

ObjectiveTo understand the levels of awareness, usage, and knowledge of biosimilars among patients, caregivers, and the general population in the US and the European Union; perceptions of biosimilars compared to originator biologics; perceived benefits and drawbacks of clinical trials; and whether advocacy groups impact patients’ willingness to try a biosimilar.MethodsAn international survey was conducted which contained up to 56 closed-ended (requiring yes/no or ranking answers) and open-ended questions, depending on the population assigned. The survey was divided into distinct sections, including medication-class awareness, usage, and knowledge about biologic and biosimilar therapies; perceptions of clinical trials; and involvement in advocacy groups. Interviews were conducted in adults categorized as: 1) diagnosed: patients with inflammatory bowel disease including Crohn’s disease and ulcerative colitis, rheumatoid arthritis, psoriasis, breast cancer, lung cancer, colorectal cancer, or non-Hodgkin’s lymphoma; 2) diagnosed advocacy: individuals with these diseases who participated in patient support groups; 3) caregiver: has a loved one with these conditions and is involved in medical decisions; 4) general population: aged 18–64 years, without these conditions. Statistical analyses among groups within a region (US or EU) used column proportions test with a 95% confidence interval.ResultsIn all, 3,198 individuals responded. Awareness about biologic therapies was significantly higher in diagnosed, diagnosed advocacy, and caregiver groups (45%–78%) versus general population (27%; P<0.05). Across all groups, awareness of biosimilars was low; only 6% of the general population reported at least a general impression of biosimilars. Awareness was significantly higher in the diagnosed advocacy group (20%–30%; P<0.05). Gaps in knowledge about biosimilars included safety, efficacy, and access to these agents. Respondents had generally positive perceptions of clinical trials, although barriers to participation were identified.ConclusionAn immediate need exists for patient education about biosimilars and clinical trials to ensure educated and informed decisions are made about biosimilar use.

Physicians' knowledge of biosimilars "insufficient"

Physicians' knowledge of biosimilars "insufficient"

Physicians' knowledge of biosimilars "insufficient"

Physicians' knowledge of biosimilars "insufficient"