Perceptions Of Biosimilars Research Articles

Physicians’ and patients’ perception of biosimilars and factors affecting biosimilar prescribing in selected Asian countries: a survey study

ABSTRACT Background This study evaluated physicians’ and patients’ beliefs about biosimilars in Hong Kong, India, Pakistan, Singapore, Taiwan, and Thailand. Research design and methods An online survey administered to physicians (dermatologists, n = 119; gastroenterologists, n = 148; rheumatologists, n = 161) between 22 October 2021 and 7 January 2022, and patients (n = 90) with rheumatic or inflammatory bowel disease between 25 October 2021 and 12 April 2022. Results Most (68%) physicians reported having a strong knowledge about biosimilars, yet 49% indicated that biosimilars are readily available to them. Physicians cited potential cost savings (81%) as the main benefit of biosimilars, and cost/coverage support (36%), patient support (25%), and increasing biosimilar awareness/education (24%) as main strategies for improving usage. Few (21%) patients reported having a strong knowledge about biosimilars. Patients cited offering alternatives in case of drug shortages (77%) as the main benefit of biosimilars, and cost/coverage support (53%), increasing awareness of product profile (22%), and providing biosimilars with a good efficacy profile/effective product (19%) as main strategies for improving usage. Conclusion Programs focused on cost/coverage support, patient support, and biosimilar awareness could improve acceptance of biosimilars for chronic immune-mediated inflammatory diseases in Asian countries, thereby increasing patient access to essential biologic therapies.

Consensus-Based Overarching Principles and Recommendations on the Use of Biosimilars in the Treatment of Inflammatory Arthritis in the Gulf Region.

Though biologic agents have significantly improved the treatment of inflammatory arthritis (rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis), high costs, stringent regulations, strict reimbursement criteria, and existing patents have limited patient access to treatments. While being highly similar in quality, safety, and efficacy to biologic reference products, biosimilars can reduce the financial burden and prevent underutilization of medication. The objective of this initiative was to develop an evidence-based consensus of overarching principles and recommendations aimed at standardizing the use of biosimilars in treating inflammatory arthritis in the Gulf region. A task force of practicing rheumatologists, a clinical pharmacist, a health economist, patients, regulators, and payors from across the Gulf region developed recommendations and overarching principles based on the outputs of a systematic literature review conducted to address Patient-Intervention-Comparison-Outcome (PICO) questions specific to key challenges regarding the use of biosimilars for the treatment of inflammatory arthritis in the region. As the data before 2017 have been previously reviewed in another publication, the current review focused on data published between January 2017 and August 2022 (PROSPERO ID CRD42022364002). Consensus on each statement required a level of agreement of 70% or greater. Consensus was reached for five overarching principles and nine recommendations by the task force. The principles emphasize the importance of improving the awareness, understanding, and perception of biosimilars, as well as the need for regulated regional real-world data generation and protocols to make biosimilars a viable and affordable treatment option for all patients. The consensus recommendations advocate the need for shared treatment decisions between rheumatologists and patients when considering biosimilars. They further recommend that confirmation of a biosimilar's efficacy and safety in a single indication is sufficient for extrapolation to other diseases for which the reference product has been approved. Finally, there is a need for pharmacovigilance and national health policies governing the adoption and prescription of biosimilars in clinical practice across the region. These are the first consensus recommendations for the Gulf region based on a systematic literature review and Preferred Reporting Items for Systematic Review and Meta-analysis (PRISMA) guidelines, integrating clinical evidence with clinical expertise to optimize decision making for the use of biosimilars in patients with inflammatory arthritis. They were formulated based on predominantly international data because of the limited regional data and therefore can be generalized to serve as recommendations for healthcare professionals in other parts of the world.

Biosimilar perceptions among autoimmune prescribers and pharmacists in health system specialty pharmacy.

By the end of 2023, 10 self-administered biosimilars indicated for autoimmune conditions are expected to launch in the United States, resulting in alternative treatment options for patients and a potential for cost savings. However, studies about perception and knowledge of self-administered biosimilars among health system prescribers and health system specialty pharmacists are limited. To assesses knowledge and perceptions of biosimilars among autoimmune prescribers and health system specialty pharmacists across the United States. An anonymous, cross-sectional self-administered online questionnaire was conducted among prescribers and health system specialty pharmacists practicing in the specialties of rheumatology, dermatology, and gastroenterology across the United States. The survey was available from January 2023 to February 2023. 31 prescribers and 44 pharmacists completed the questionnaire. Only 16.0% of prescribers and 13.4% of pharmacists reported being "very prepared" to have conversations with patients about biosimilar options. 43% of prescribers indicated they would prescribe a biosimilar to biologic naive patients. However, 13.3% of prescribers would be willing to prescribe a biosimilar to patients successfully established on biologic therapy. Among pharmacists, 68.1% were comfortable recommending a biosimilar substitution to a biologic naive patient, but only 18.1% would recommend a biosimilar substitution to an existing patient successfully established on a biologic therapy. Less than half of prescribers (48.0%) and pharmacists (42.0%) understood regulations of interchangeability and substitution. Our study highlights several knowledge gaps and hesitancies that exist among health system specialty prescribers and pharmacists regarding biosimilar products. Education efforts are needed to overcome the lack of biosimilar adoption, which will increase affordability of therapy for patients and health care savings.

Unveiling the Biosimilar Paradox of Oncologists' Perceptions and Hesitations in South Korea: A Web-Based Survey Study.

Biosimilars offer a cost-effective alternative to original biopharmaceuticals with comparable efficacy and safety. The perception and familiarity of prescribers toward biosimilars play a critical role in their market penetration. Yet, few studies have explored the perception of oncologists toward biosimilars, much less in Asia. The objective of this study is to understand barriers of adopting biosimilars among oncologists and explore strategies to promote their use in clinical practice settings. A web-based survey was conducted among Korean oncologists from September to October 2022, assessing their perception of biosimilars and prescribing practices. Among the 118 surveyed oncologists, 75.4% (89 out of 118) had previously prescribed biosimilars. When asked about their preference, 48.3% (57 out of 118) of the respondents preferred originators to biosimilars, whereas 16.1% (19 out of 118) favored biosimilars over the originators. The primary reason for preferring the originators was trust in safety and efficacy (94.7%, 54 out of 57). Still, a paradox was noted as 87.0% (47 out of 54) and 85.2% (46 out of 54) of these also acknowledged the comparable efficacy and safety of biosimilars. A relatively small number of the respondents (16.1%, 19 out of 118) did not consider prescribing biosimilars to biologic-naïve patients at all, and up to 56.8% (67 out of 118) expressed reluctance to switch prescriptions from originators to biosimilars. However, 90.7% (107 out of 118) of respondents considered changing their prescription to biosimilars if patients faced financial stress. Concerns regarding the efficacy when switching to biosimilars were expressed by 42.7% (38 out of 89) of oncologists with biosimilar prescribing experience, increasing to 69.0% (20 out of 29) among those without such experience. Korean oncologists perceived biosimilars to be as safe and effective as originators. However, there is a notable mismatch between this perception and their prescribing practices, particularly among those who have not prescribed biosimilars before. The financial burden of patients served as a significant driver for prescribing biosimilars, yet marginal price differences between originators and biosimilars may be associated with the low adoption rate of biosimilars in Korea. Active price competition may enhance market penetration of biosimilars.

P85 Switching from adalimumab originator to biosimilar: a 3-year retrospective cohort analysis

Abstract Biological drugs have revolutionized the treatment of immune-mediated inflammatory diseases. Clinical experience and evidence suggest that biosimilars can be used as safely and effectively as their originator. However, patients’ perceptions of biosimilars are that they are inferior to the originator. Currently, few studies have assessed the tolerability and efficacy of switching from the adalimumab originator to a biosimilar in patients with well-controlled moderate-to-severe psoriasis. Our objective was to describe the clinical experience of switching patients from the adalimumab originator to a biosimilar and that of switching back to the originator for those intolerant to biosimilars. A single-centre, retrospective cohort study was conducted to identify patients with moderate-to-severe psoriasis who had switched from the adalimumab originator (Humira®) to a biosimilar (Amgevita® or Imraldi®) from 2018 to 2022. Patient data were obtained from a combination of patient records and databases, including the British Association of Dermatologists Biologics and Immunomodulators Register (BADBIR) and the National High Tech Prescribing Hub. Patients were excluded from the study if their treatment duration on an adalimumab biosimilar was < 16 weeks or if they were being treated for an indication other than psoriasis. From 2018 to 2022, 100 patients who switched from the adalimumab originator to a biosimilar were identified. At week 16, 81 patients (81%) maintained their initial switch from the adalimumab originator to biosimilar. Nineteen (19%) patients who were switched to an adalimumab biosimilar were switched back to the originator secondary to adverse events. Maintenance or improvement in baseline Psoriasis Area and Severity Index (PASI) and Dermatology Life Quality Index (DLQI) was observed in 91% and 90%, respectively, in patients who remained on a biosimilar. For those intolerant to biosimilars, maintenance or improvement in baseline PASI and DLQI was still observed although in fewer patients: 63% and 47%, respectively. Our study demonstrates that drug efficacy was recaptured and adverse events were ameliorated for all patients switched from an adalimumab biosimilar back to the originator. For patients who did not tolerate biosimilar switch, reasons for switching back to the originator mirrored those reported in the literature. All patients who switched back to the originator from a biosimilar recovered from loss of efficiency and the adverse events they had reported. Physicians should be confident in switching patients with well-controlled psoriasis to adalimumab biosimilars. For the small proportion of patients who experienced loss of efficacy or adverse events, all were recaptured by either switching to an alternative adalimumab biosimilar or switching back to the adalimumab originator.

"Biosimilar, so it looks alike, but what does it mean?" A qualitative study of Danish patients' perceptions of biosimilars.

Biosimilars are highly similar follow‐on products for biologics that can foster biologics competition. Questionnaire studies have attempted to gauge the patient perspective on biosimilars, but none have delved deeper into how patients view biologics and switching of these. Considering Denmark has one of the highest biosimilar uptakes worldwide, the aim of this study was to investigate how Danish patients with psoriasis, arthritic diseases or inflammatory bowel disease perceive biosimilars. Twelve participants were semi‐structurally interviewed in either a focus group or an internet‐based, individual interview between May 2019 and July 2019. Content analysis was inductively applied. Participants on originators voiced more reluctance towards using biosimilars than those already using them. Both participants using originator and biosimilar products expressed concerns about reoccurrence of disease symptoms due to differences in effectiveness and safety. Participants generally struggled with understanding biosimilarity, and they voiced a need to be well‐informed about switching. They were all aware of and accepted how healthcare budget restrictions played a role in the push to use biosimilars. To improve biosimilar uptake and willingness to switch to a biosimilar, patient‐centred information on efficacy and safety and explanation of the societal benefits of the savings from using biosimilars must be carefully communicated.

Knowledge and perception of biosimilars in ambulatory care: a survey among Belgian community pharmacists and physicians

BackgroundWith the approval of biosimilars for subcutaneously administered products, such as adalimumab, etanercept and insulin, biosimilars become increasingly available in ambulatory care. Little is known about the knowledge and attitudes of healthcare providers who are in charge of dispensing and prescribing biosimilars in this context. This study aims to assess the knowledge and perception about biosimilars among community pharmacists and physicians.MethodsBelgian community pharmacists (n = 177) and physicians (n = 30) were surveyed on their knowledge, experience with dispensing/prescribing biologicals including biosimilars, perception regarding interchangeability, switching and substitution and informational and educational needs. Descriptive and statistical analyses were performed.ResultsOnly 32% of community pharmacists and 52% of physicians had yet dispensed/prescribed a biosimilar. Approximately 35% of community pharmacists felt insufficiently trained to counsel patients with biosimilar therapy, which was significantly higher compared to their self-assessed competence to counsel patients with biological therapy in general (p = 0.023). Community pharmacists experienced questions about similarity between reference products and biosimilars (47%) and their interchangeability (42%). Over 40% of physicians found patient uncertainty about efficacy and safety challenging when prescribing biosimilars. A similar proportion of physicians would only prescribe a biosimilar in indications for which the biosimilar has been tested clinically. The majority of pharmacists (58%) was in favor of substitution of biologicals, on the condition that the prescriber would be contacted. Also over 40% of physicians was open to this approach in case of substitution. Educational support, budget for additional staff and transparency about savings were considered suitable stimuli to incentivize biosimilar use. The need for information about biologicals including biosimilars was nearly unanimous among community pharmacists. Also 67% of physicians requested more information. Both community pharmacists and physicians preferred to be informed by their respective professional associations.ConclusionsThis study showed a substantial need for targeted educational measures to increase the knowledge and confidence about both biological medicines in general and biosimilars in particular among Belgian community pharmacists and physicians. The results may inform educational and policy measures to stimulate biosimilar use in ambulatory care.

Physicians’ perceptions of the uptake of biosimilars: a systematic review

ObjectivesTo examine physicians’ perceptions of the uptake of biosimilars.DesignSystematic review.Data sourcesMedLine Ovid and Scopus databases at the end of 2018.Eligibility criteriaOriginal scientific studies written in English that addressed physicians’ perceptions...

Patients’ beliefs and behaviours are associated with perceptions of safety and concerns in a hypothetical biosimilar switch

Although patient acceptance is important for biosimilar adoption and reducing healthcare costs, many patients perceive biosimilars to be unsafe and have concerns about switching. Studies show that patients' characteristics influence negative perceptions toward generic drugs, but little research has explored biosimilar acceptance. This study examines which demographic and psychological characteristics are associated with patients' safety perceptions and concerns about switching to biosimilars. Ninety-six patients taking bio-originators for rheumatic conditions (65% for rheumatoid arthritis) completed the Brief Illness Perceptions Questionnaire, Beliefs about Medicines Questionnaire and Perceived Sensitivity to Medicines Scale. Demographic factors, information seeking, concerns about switching and safety perceptions were also assessed. Pearson's correlations and hierarchical linear regressions were conducted to explore whether patient characteristics are associated with perceptions of biosimilars. Negative safety perceptions were associated with being female, short-term bio-originator use, illness beliefs, seeking health information online, high perceived sensitivity to medicines and negative beliefs about medicines. Only being female (β = 0.24, P = 0.02) was independently associated. More concerns about switching were associated with being female, illness beliefs, high perceived sensitivity to medicines, information-seeking behaviours and preferring innovator drugs. Seeking health information online (β = 0.20, P = 0.04), preferring innovator drugs (β = 0.29, P = 0.004) and stronger emotional responses (β = 0.26, P = 0.01) were independently associated. Perceived bio-originator effectiveness was inversely associated with preferring biosimilars (rs= - 0.33, P < 0.001). Patients who have stronger emotional responses to their condition, are females, seek health information online and prefer innovator drugs that have more negative perceptions about biosimilars. Experiences with bio-originators influence attitudes towards switching.

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.

Strategies for Overcoming Barriers to Adopting Biosimilars and Achieving Goals of the Biologics Price Competition and Innovation Act: A Survey of Managed Care and Specialty Pharmacy Professionals.

The Biologics Price Competition and Innovation Act (BPCIA) of 2009, which included pathways for FDA approval of biosimilar products, was designed to promote more affordable, expanded patient access to biologic therapies. Achieving these BPCIA goals depends on overcoming formidable barriers to biosimilar adoption. Managed care and specialty pharmacy professionals are uniquely qualified to inform initiatives to address these barriers. To assess perceptions regarding strategies for overcoming barriers to biosimilar adoption among managed care and specialty pharmacy professionals by conducting a survey study. Invitations to complete the online survey were emailed by the Academy of Managed Care Pharmacy (AMCP) to members and customers and to contacts sourced from a commercial database. In addition to questions on respondent demographics and perceptions of biosimilars, the survey listed 16 strategies for overcoming key barriers to biosimilar adoption. On a 5-point scale, participants rated their opinion on the likelihood that each strategy would have the potential to assist in achieving BPCIA goals. The survey also listed 6 barriers to biosimilar adoption. On a 5-point scale, participants rated their perceived difficulty in overcoming each barrier. The survey concluded with an open-text item that asked participants to list 3 additional strategies for overcoming biosimilar adoption barriers. Response frequencies were calculated to describe participants' ratings of the strategies and barriers. Statistical analyses were conducted to assess whether the ratings differed among respondents grouped by work organization. For the open-text item, we conducted qualitative content analyses to categorize strategies by stakeholder groups that might take primary implementation roles. A total of 300 managed care and specialty pharmacy professionals completed the survey. There was considerable variation in the preferences, policies, and practices regarding biosimilar adoption among respondents' work organizations. Responses to several survey items reflected positive attitudes about the safety and efficacy of biosimilars; for example, 84% agreed or strongly agreed that FDA-approved biosimilars are safe and effective for patients who switch from a reference biologic. Based on pooled percentages for ratings of likely and extremely likely to overcome barriers to biosimilar adoption, the highest-rated strategies were for prescriber education about evidence from switching studies (91%) and FDA guidance on pharmacy-level substitution of reference biologics with biosimilars (90%). The lowest-rated strategies were for requiring therapeutic drug monitoring for patients who switch to biosimilars (39%) and using quotas to incentivize providers to prescribe biosimilars (40%). For the qualitative analysis, the highest numbers of respondents' suggested strategies indicated primary implementation roles of biosimilar manufacturers (40%), the federal government (26%), and managed care organizations (15%). Reflecting the unique knowledge, perspectives, and practices of managed care and specialty pharmacy professionals, the study findings are relevant to informing and advancing initiatives for achieving BPCIA goals. The survey study reported in this article was part of a continuing education program funded by an independent educational grant, which was awarded by Sandoz, a Novartis Division, to PRIME Education. The Academy of Managed Care Pharmacy (AMCP) received grant funding from PRIME to assist in developing the survey and writing the manuscript. The grantor had no role in the study design, execution, analysis, or reporting. Greene and Pardo are employed by PRIME. Singh and Carden are employed by AMCP. Greene, Singh, Carden, and Pardo have no other disclosures. Lichtenstein received an honorarium from PRIME for serving as faculty for the continuing education program and has been a consultant for Pfizer, Cellceutix, and Merck.

PSY130 - Perceptions of Biosimilars Across Physician Specialities in Europe

This study assessed perceptions of biosimilars across physician specialties (rheumatology, dermatology, gastroenterology) in EU5 to gain insights on patient access. A cross-sectional survey was conducted in Q4 2016 in the EU5 among national, regional and hospital physicians. Respondents completed a Physician Biosimilar Perceptual Questionnaire, which assessed the overall perception of anti-TNF biosimilars, specific barriers to prescribing them and cost factors influencing the current use and adoption of biosimilars. A total of 670 physicians (n=250 rheumatologists; n=220 dermatologists; n=200 gastroenterologists) in the EU5 were recruited as part of the study. Rheumatologists tended to possess greater awareness of biosimilars, most notably in the treatment of rheumatoid arthritis (RA; 83%) when compared to dermatologists (61%) and gastroenterologists (72%-74%). Gastroenterologists expressed the greatest level of agreement with statements concerning the efficacy, safety and trustworthiness of biosimilars, with nearly half (range: 37% to 54%) of this group agreeing with such statements as “I trust biosimilars as much as branded biologics”. Dermatologists (range: 14% to 38%) and rheumatologists (range: 25% to 41%) possessed similar but lower levels of agreeance with such statements. Whereas both rheumatologists and gastroenterologists reported unfavorable associations between biosimilars and statements regarding long-term efficacy and safety, these specialists did possess a favorable association with formulary coverage. In contrast, dermatologists, who possess less experience with biosimilars, had few favorable associations across the surveyed domains. Differences emerged in the perception of biosimilars across physician specialties in the EU5. Whereas rheumatologists expressed the greatest level of awareness of biosimilars, gastroenterologists possessed the most confidence in their safety and efficacy. These results suggest that tailored education targeted to specialty could enhance adoption of biosimilars in the treatment of chronic immunologic conditions.

Perception of Originator Biologics and Biosimilars: A Survey Among Belgian Rheumatoid Arthritis Patients and Rheumatologists.

Among patients and rheumatologists, current knowledge and perception of biosimilars in comparison with originator biologics is unknown. The aim of this study was to investigate this knowledge and perception in Belgian rheumatologists and rheumatoid arthritis (RA) patients. Anonymous web surveys were conducted in Belgian RA patients (n=121) and rheumatologists (n=41) during the period January-March 2016. The surveys covered topics on knowledge, similarity, price, preference, interchangeability, extrapolation and switching. Descriptive and statistical analyses of responses were performed. Familiarity with biosimilars was reported by 49% of patients, of whom 77% knew what biosimilars were. RA patients equally questioned the proven efficacy of originators and biosimilars in RA, as well as their side effects and suitability. Furthermore, RA patients questioned the safety of biosimilars more often than that of originators (35 vs. 20%, respectively; p=0.0094). Rheumatologists, more so than patients, expressed concerns that there might be differences between originators and biosimilars in terms of quality, safety, and price (p=0.0292, p<0.0001, p=0.0129, respectively). The opinions of rheumatologists on interchangeability and extrapolation of indications varied. The price of an originator contributed substantially to the medicine preference of rheumatologists (p=0.0002), but not patients. Our study showed that rheumatologists, more so than patients, were convinced that there can be differences between originators and biosimilars. Despite safety being the major concern of patients, patients trusted their physician's decision to start on or switch to a biosimilar. The evolution of the uptake of biosimilars in Belgium might thus depend mainly on the perception of physicians.

Medical specialists' attitudes to prescribing biosimilars.

Biosimilars are a cost-effective alternative to biologics that could improve patients' access to expensive biological medicines. Currently, there are little data on doctors' perceptions of biosimilars and in what situations they are comfortable prescribing biosimilars. In this study, we investigated medical specialists' perceptions of biosimilars and the factors associated with the acceptance of biosimilars. A national sample of 110 of 327 medical specialists working in the areas of rheumatology, dermatology, gastroenterology, oncology and haematology completed an online questionnaire examining attitudes towards prescribing biosimilars, indication extrapolation and switching patients to a biosimilar. Most specialists held positive views of biosimilars, with between 54 and 74% confident in the safety, efficacy, manufacturing and pharmacovigilance of biosimilars. Seventy-one percent of specialists agreed that they would prescribe biosimilars for all or some conditions meeting relevant clinical criteria. Specialists were less confident about indication extrapolation and switching patients from an existing biologic. Acceptance of biosimilars was significantly associated with a lower perceived time to explain a biosimilar to a patient and lower number of weekly patient appointments. The most common situations that they would not prescribe a biosimilar was where there was a lack of clinical data supporting efficacy (32%), or evidence of adverse effects (17%). Medical specialists held generally positive attitudes towards biosimilars but were less confident in indication extrapolation and switching patients from a biologic. Providing clinicians with guidance on how to explain biosimilars to patients and written patient material may help overcome some of the barriers to the use of biosimilars. Copyright © 2017 John Wiley & Sons, Ltd.