Rheumatologists’ Perceptions of Biosimilar Medicines Prescription: Findings from a French Web-Based Survey

Beck, M.; Michel, Bruno; Rybarczyk-Vigouret, Marie-Christine; Levêque, Dominique; Sordet, Christelle; Sibilia, Jean; Velten, Michel

doi:10.1007/s40259-016-0202-5

Cited by 43 publications

(51 citation statements)

References 26 publications

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“…Twenty surveys met the inclusion criteria and were included in this systematic review ( Figure 1). The included studies originated from the United States of America [15][16][17] , Belgium 18,19 , France [20][21][22] , Germany 23,24 , Italy 25 , Ireland 26 , Malta 27 , Hungary 28 , and the United Kingdom (UK) 29 (Table 1).…”

Section: Resultsmentioning

confidence: 99%

“…Sixteen studies quantified clinicians' biosimilar prescribing habits. 15,17,[29][30][31][32][33][34]19,[21][22][23][24][25][26]28 In Danese et al 30 (EU, 2014), 61% of gastroenterologists felt little or no confidence in using biosimilars, 26% felt confident enough, 8% felt very confident, and 5% felt totally confident. When the survey was repeated one year after biosimilars became available in the EU, confidence had increased, as 19.5% of gastroenterologists felt little or no confidence in using biosimilars, 33.9% felt confident enough, 17.8% felt very confident, and 28.8% felt totally confident (EU, 2016).…”

Section: Biosimilar Prescribing Behaviorsmentioning

confidence: 99%

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Factors Affecting Health Care Provider Knowledge and Acceptance of Biosimilar Medicines: A Systematic Review

Leonard

Wascovich

Oskouei³

et al. 2019

JMCP

106

133

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Background: Newly developed biosimilar agents confer significant cost saving advantages, yielding the potential to mitigate rising drug costs and expand patient access to care for important biologic therapies. Biosimilar market uptake greatly depends upon healthcare provider willingness to promote, prescribe, and use biosimilars in clinical practice. Objective: To perform a systematic review evaluating current United States (U.S.) and European (EU) health care provider knowledge, perceptions, and prescribing behaviors of biosimilar medicines to assess the need for clinician-directed, biosimilar education. Methods: An electronic literature search was conducted using journal databases, including PubMed, Embase, and Cochrane Library. Terms related to biosimilar agents, survey questionnaires, and education were used. Two independent reviewers evaluated 158 citations published from January 1, 2014 to March 5, 2018, that were the result of this search. Studies in English were included if they surveyed U.S. or EU physician and/or pharmacist knowledge, attitudes, and/or prescribing preferences of biosimilar drugs. Overall trends in prescribing behavior and perceptions were abstracted. Results: A total of 20 studies met inclusion criteria. Three studies originated from the U.S. and 17 from Europe. Hospital specialists, gastroenterologists, and rheumatologists were the most frequently surveyed practitioners. Percent of biosimilar prescribing varied widely between countries and within similar practice fields. If used, biosimilars were predominantly prescribed in biologic-treatment naïve patients. An overall lack of biosimilar familiarity in both U.S. and EU health care settings accompanied concerns about biosimilar safety, efficacy, extrapolation, and interchangeability. Detailed descriptions of biosimilar education programs were lacking from the literature. Conclusions: Findings from this review indicate that U.S. and EU healthcare providers still approach biosimilar medicines with caution, citing limited biosimilar knowledge, low prescribing comfort, and safety and efficacy concerns as main deterrents for biosimilar use. To realize the full cost-saving potential of biosimilar medicines, clinician-directed, biosimilar education will be imperative to address gaps in biosimilar knowledge, facilitate prescribing changes, and ultimately increase biosimilar use.

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Section: Resultsmentioning

confidence: 99%

Section: Biosimilar Prescribing Behaviorsmentioning

confidence: 99%

Factors Affecting Health Care Provider Knowledge and Acceptance of Biosimilar Medicines: A Systematic Review

Leonard

Wascovich

Oskouei³

et al. 2019

JMCP

106

133

View full text Add to dashboard Cite

show abstract

“…A recent survey among U.S.‐based specialty physicians who already prescribe biologics revealed that, although the majority of respondents had heard of biosimilars, in‐depth knowledge of fundamental concepts such as the “totality of the evidence” was low . Other physician surveys have revealed general positivity toward biosimilars but uncertainty regarding issues such as extrapolation . Similar knowledge gaps are likely among pharmacists, nurses, and other health care practitioners .…”

Section: Health Care Professional and Patient Perceptions: Trust And mentioning

confidence: 99%

Global Acceptance of Biosimilars: Importance of Regulatory Consistency, Education, and Trust

et al. 2018

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Biosimilars of monoclonal antibody anticancer therapies are beginning to emerge, and more are likely to become available for clinical use in the near future. The extent to which biosimilars can contribute to cancer care will depend on their level of acceptance by health care systems, health care professionals, and patients. A better understanding of the regulatory basis for the approval of biosimilars may enhance confidence and trust in these agents. In order to have informed discussions about treatment choices with their patients, oncologists should familiarize themselves with the biosimilar paradigm.

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“…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

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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

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Rheumatologists’ Perceptions of Biosimilar Medicines Prescription: Findings from a French Web-Based Survey

Cited by 43 publications

References 26 publications

Factors Affecting Health Care Provider Knowledge and Acceptance of Biosimilar Medicines: A Systematic Review

Factors Affecting Health Care Provider Knowledge and Acceptance of Biosimilar Medicines: A Systematic Review

Global Acceptance of Biosimilars: Importance of Regulatory Consistency, Education, and Trust

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

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