Healthcare professionals’ perceptions and perspectives on biosimilar medicines and the barriers and facilitators to their prescribing in UK: a qualitative study

Aladul, Mohammed I.; Fitzpatrick, R; Chapman, Stephen

doi:10.1136/bmjopen-2018-023603

Cited by 44 publications

(39 citation statements)

References 24 publications

(17 reference statements)

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Most of the 23 selected publications used surveys, typically web-based questionnaires with 11-22 questions, or fully structured short interviews (n=17). 10 17 18 22-27 30-32 34-38 In addition, there were one qualitative interview study 19 and two real-world cross-sectional studies (n=2) 28 29 in which physicians filled a survey form and reported their prescribing, then recruited patients who also filled a questionnaire form to provide information on how the reported prescribing was actualised in practice. There were also discrete choice method surveys (n=2) 20 21 in which prescribers were given a hypothetical scenario and possible treatment options, and had to choose their preferred alternative.…”

Section: Study Characteristicsmentioning

confidence: 99%

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

et al. 2020

View full text Add to dashboard Cite

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 of the uptake of biosimilars.Data extraction and synthesisThe search resulted in altogether 451 studies and 331 after removing duplicates. Two researchers examined these based on the title, abstract and entire text, resulting in 20 studies. The references in these 20 studies were screened and three further studies were included. The data of these 23 studies were extracted. All the publications were quality assessed by two researchers.ResultsMost of the selected studies were conducted in Europe and commonly used short surveys. Physicians’ familiarity with biosimilars varied: 49%–76% were familiar with biosimilars while 2%–25% did not know what biosimilars were, the percentages varying from study to study. Their measured knowledge was generally more limited compared with their self-assessed knowledge. Physicians’ perceptions of biosimilars also varied: 54%–94% were confident prescribing biosimilars, while 65%–67% had concerns regarding these medicines. Physicians seemed to prefer originator products to biosimilars and prescribed biosimilars mainly for biologic-naive patients. They considered cost savings and the lower price compared with the originator biologic medicine as the main advantages of biosimilars, while their doubts were often related to safety, efficacy and immunogenicity. 64%–95% of physicians had negative perceptions of pharmacist-led substitution of biologic medicines.ConclusionsPhysicians’ knowledge of and attitudes towards biosimilars vary. Although physicians had positive attitudes towards biosimilars, prescribing was limited, especially for patients already being treated with biologic medicines. Perceptions of pharmacist-led substitution of biologic medicines were often negative. Education and national recommendations for switching and substitution of biologic medicines are needed to support the uptake of biosimilars.

show abstract

Section: Study Characteristicsmentioning

confidence: 99%

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

et al. 2020

View full text Add to dashboard Cite

show abstract

“…According to our findings, patient’s knowledge of use of the administration devices is one of the key factors to the success of substitution. The different administration devices can present an obstacle to switching 42. However, all administration devices for biosimilars and their reference products have been tested for usability at the time of marketing authorisation 43.…”

Section: Discussionmentioning

confidence: 99%

“…Frequent switching could overload the pharmacies in patient counselling and increase the risk of medication errors and potential switch-related adverse effects, such as nocebo effect. Multiple switches may also confuse patients and their caregivers 42. Troubleshooting may also be difficult in cases of frequent switching and adverse effects with long latency, such as immunogenicity and loss of efficacy.…”

Section: Discussionmentioning

confidence: 99%

Medication safety risks to be managed in national implementation of automatic substitution of biological medicines: a qualitative study

et al. 2019

View full text Add to dashboard Cite

ObjectivesTo explore relevant Finnish stakeholders’ perceptions on the automatic substitution of biological medicines with particular focus on medication safety and issues that need to be considered to create an appropriate model for automatic biological product substitution.DesignQualitative interview study.MethodsData were collected in semistructured individual (n=17), pair (n=7) and group (n=8) interviews (32 interviews, 62 participants) in 2018. Participants represented a wide range of stakeholders involved in the pharmacotherapy process: community pharmacists (n=8 interviews), authorities (n=7), prescribers (n=7), pharmaceutical industry and wholesalers (n=6), patients/customers (n=2), hospital pharmacists (n=1) and nurses (n=1). Inductive content analysis was performed.ResultsBenefits of automatic substitution were identified as cost savings, more patients receiving biological treatments and enhanced continuity of treatment. Six major risk categories were identified: (1) the patient’s medication is interrupted or complicated temporarily or permanently, (2) the patient uses two products with the same active substance, (3) the traceability of the product is compromised, (4) the patient cannot get into healthcare in case of problems, (5) the patient does not receive substitution-related advice from a pharmacy and (6) the patient is distracted by the support material he/she receives. Several risk mitigation measures were commonly mentioned: medication and device counselling by pharmacists (n=23), infrequent substitution interval (n=15) and better knowledge on biosimilars among healthcare providers (n=13).ConclusionAutomatic substitution of biologics is associated with risks that should be prospectively managed before implementing the procedure. The substitution also introduces new tasks and communication needs to those involved in actual medication use process, particularly to community pharmacists who will be responsible for substitution and counselling the patients.

show abstract

“…Although the uptake of biosimilars has increased considerably over recent years [3][4][5], some physicians have expressed concerns about the manufacturing process and quality [4]. Such concerns may be partly fuelled by reports of the potential for variability in the manufacturing process which might lead to divergence or 'drift' between biosimilars and the reference product.…”

Section: Introductionmentioning

confidence: 99%

Batch-to-Batch Consistency of SB4 and SB2, Etanercept and Infliximab Biosimilars

Ebbers

Fehrmann²,

Ottosen³

et al. 2020

BioDrugs

View full text Add to dashboard Cite

Background Biosimilars must meet stringent regulatory requirements, both at the time of authorization and during their lifecycle. Yet it has been suggested that divergence in quality attributes over time may lead to clinically meaningful differences between two versions of a biologic. Therefore, this study investigated the batch-to-batch consistency across a range of parameters for released batches of the etanercept biosimilar (SB4) and infliximab biosimilar (SB2). Methods SB4 (Benepali ® ) and SB2 (Flixabi ® ) were both developed by Samsung Bioepis and are manufactured in Europe by Biogen at their facility in Hillerød, Denmark. A total of 120 batches of SB4 and 25 batches of SB2 were assessed for consistency and compliance with specified release parameters, including purity, post-translational glycosylation (SB4 only), protein concentration, and biological activity. Results The protein concentration, purity, tumor necrosis factor-α (TNF-α) binding, and TNF-α neutralization of all batches of SB4 and SB2 were within the strict specification limits set by regulatory agencies, as was the total sialic acid (TSA) content of all batches of SB4. Conclusions Quality attributes of SB4 and SB2 batches showed little variation and were consistently within the rigorous specifications defined by regulatory agencies.As of August 2019, the Biogen Hillerød facility (Denmark) became Fujifilm Diosynth Biotechnologies Denmark ApS, a contract development and manufacturing organization (CDMO) for the manufacture of biosimilars developed by Samsung Bioepis. Key PointsBiosimilars are held to the same rigorous quality standards as any other biologic. SB4 and SB2 biosimilars demonstrated a high degree of batch-to-batch consistency.Quality attributes including purity, percentage of high molecular weight species, tumor necrosis factor-α (TNFα) binding, and TNF-α neutralization remained well within acceptance limits. 2

show abstract

Healthcare professionals’ perceptions and perspectives on biosimilar medicines and the barriers and facilitators to their prescribing in UK: a qualitative study

Cited by 44 publications

References 24 publications

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

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

Medication safety risks to be managed in national implementation of automatic substitution of biological medicines: a qualitative study

Batch-to-Batch Consistency of SB4 and SB2, Etanercept and Infliximab Biosimilars

Contact Info

Product

Resources

About