Biosimilar medicines: Why the science matters

González‐Quevedo, Rosa; Wolff-Holz, Elena; Carr, Melanie; Burgos, Juan García

doi:10.1016/j.hlpt.2020.03.004

Cited by 5 publications

(7 citation statements)

References 4 publications

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“…As recognized by the interviewees, extensive efforts have been made by European regulators to provide clear information regarding biosimilars and the science behind the regulatory evaluation to the public [ 2 , 52 – 57 ]. Investments in providing unbiased biosimilar information and conveying trust in the regulatory evaluation must be continued (recommendation 1) to further improve stakeholder understanding.…”

Section: Discussionmentioning

confidence: 99%

European Stakeholder Learnings Regarding Biosimilars: Part I—Improving Biosimilar Understanding and Adoption

et al. 2020

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Background Despite the benefits offered by biosimilars in terms of cost savings and improved patient access to biological therapies, and an established regulatory pathway in Europe, biosimilar adoption is challenged by a lack of knowledge and understanding among stakeholders such as healthcare professionals and patients about biosimilars, impacting their trust and willingness to use them. In addition, stakeholders are faced with questions about clinical implementation aspects such as switching. Objective This study aims to provide recommendations on how to improve biosimilar understanding and adoption among stakeholders based on insights of healthcare professionals (physicians, hospital pharmacists, nurses), patient(s) (representatives) and regulators across Europe. Method The study consists of a structured literature review gathering original research data on stakeholder knowledge about biosimilars, followed by semi-structured interviews across five stakeholder groups including physicians, hospital pharmacists, nurses, patient(s) (representatives) and regulators across Europe. Results Although improvement in knowledge was observed over time, generally low to moderate levels of awareness, knowledge and trust towards biosimilars among healthcare professionals and patients are identified in literature ( N studies = 106). Based on the provided insights from interviews with European experts ( N = 44), a number of challenges regarding biosimilar stakeholder understanding are identified, including a lack of practical information about biosimilars and their use, a lack of understanding about biosimilar concepts and a lack of knowledge about biologicals in general. Misinformation by originator industry is also believed to have impacted stakeholder trust. In terms of possible solutions and actions to improve stakeholder understanding, broad support exists to (1) organize initiatives focussed on explaining the rationale behind biosimilar concepts and the approval pathway, (2) invest in education about biologicals in general, (3) develop clear and one-voice regulatory guidance about biosimilar interchangeability and switching across Europe, (4) disseminate real-world clinical biosimilar (switch) data, (5) share biosimilar experiences by key opinion leaders and among peers, (6) provide practical biosimilar product information, (7) provide guidance about biosimilar use, (8) actively counterbalance misinformation and organize information initiatives by neutral entities, (9) organize multi-stakeholder informational and educational efforts, aligning information between involved stakeholder groups and (10) design initiatives in a way that ensures active information uptake. Furthermore, interviewees argue that governments should be proactive in these regards. Conclusions This study argues in favour of a structural, multi-stakeholder framework at b...

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Section: Discussionmentioning

confidence: 99%

European Stakeholder Learnings Regarding Biosimilars: Part I—Improving Biosimilar Understanding and Adoption

et al. 2020

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“…Biosimilar approval may rely in part on the knowledge of the reference product and is predominately based on comparative analytical and functional data, since this is a much more sensitive approach in detecting potential differences than a clinical study. As such, generally fewer clinical studies need to be carried out for a biosimilar than for the reference product [ 5 , 7 , 8 ].…”

Section: Introductionmentioning

confidence: 99%

“…As biosimilars represent a different development and approval paradigm, their acceptance by healthcare providers, patients and policy makers may require a change in mind-set [ 7 ]. Multiple studies have assessed the awareness and knowledge about biosimilars among healthcare providers and patients, identifying generally low to moderate levels of knowledge and trust in biosimilars and related concepts [ 14 ].…”

Section: Introductionmentioning

confidence: 99%

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

Barbier

Vandenplas

Simoens

et al. 2021

J of Pharm Policy and Pract

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Background With 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. Methods Belgian 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. Results Only 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. Conclusions This 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.

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“…While biosimilar evaluation and approval relies on a solid centrally coordinated European regulatory pathway, with external stakeholder dissemination strategies to explain the underlying science underpinning their evaluation and use ( 19 , 26 , 33 , 44 , 45 ), this study found that at the national level the information and guidance available on biosimilars considerably varies between medicines agencies. Information on biosimilars, and positions on their use, i.e., on interchangeability, and the associated practices of switching and substitution, are not consistently available and vary in extent and content.…”

Section: Discussionmentioning

confidence: 90%

“…Several studies have shown rather limited knowledge and confidence levels in biosimilars among European healthcare providers and patients, indicating uncertainty and resulting in hesitation to use them ( 10 – 18 ). Limited understanding and trust in biosimilars may in part be explained by the fact that the science underpinning biosimilar development poses a new paradigm, different from that of the development of novel drugs, for stakeholders to become acquainted to, understand and trust, and a general lack of understanding of biological medicines and biotechnology ( 19 , 20 ). Furthermore, disparagement and misinformation about biosimilars, whether intentional or otherwise, is considered to have strongly contributed to misconceptions about biosimilars among healthcare providers and patients ( 21 , 22 ).…”

Section: Introductionmentioning

confidence: 99%

Regulatory Information and Guidance on Biosimilars and Their Use Across Europe: A Call for Strengthened One Voice Messaging

et al. 2022

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BackgroundBeyond evaluation and approval, European and national regulators have a key role in providing reliable information on biosimilars and the science underpinning their development, approval, and use.ObjectivesThis study aims to (i) review biosimilar information and guidance provided by EMA and national medicines agencies and (ii) explore stakeholder perspectives on the role of regulators in enabling acceptance and use of biosimilars.MethodsThis study consists of (i) a comparative review of regulatory information and position statements across medicine agencies (n = 32) and (ii) qualitative interviews with stakeholders in Europe (n = 14).ResultsThe comparative analysis showed that regulatory information and guidance about biosimilars offered by national medicines agencies in Europe varies, and is limited or absent in multiple instances. Approximately 40% (13/31) of the national medicines agencies' websites did not offer any information regarding biosimilars, and for about half (15/31) no educational materials were provided. Only less than half of national medicines agencies provided guidance on biosimilar interchangeability and switching (8/31 and 12/31, respectively). Among the national medicines agencies that did offer guidance, the extent (e.g., elaborate position vs. brief statement) and content (e.g., full endorsement vs. more cautious) of the guidance differed substantially. Countries that have a strong involvement in EU level biosimilar regulatory activities generally had more elaborate information nationally. Interviewees underwrote the need for (national) regulators to intensify biosimilar stakeholder guidance, especially in terms of providing clear positions regarding biosimilar interchangeability and switching, which in turn can be disseminated by the relevant professional societies more locally.ConclusionThis study revealed that, despite strong EU-level regulatory biosimilar guidance, guidance about biosimilars, and their use differs considerably across Member States. This heterogeneity, together with the absence of a clear EU-wide position on interchangeability, may instill uncertainty among stakeholders about the appropriate use of biosimilars in practice. Regulators should strive for a clear and common EU scientific position on biosimilar interchangeability to bridge this gap and unambiguously inform policy makers, healthcare professionals, and patients. Furthermore, there is a clear opportunity to expand information at the national level, and leverage EU-developed information materials more actively in this regard.

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Biosimilar medicines: Why the science matters

Cited by 5 publications

References 4 publications

European Stakeholder Learnings Regarding Biosimilars: Part I—Improving Biosimilar Understanding and Adoption

European Stakeholder Learnings Regarding Biosimilars: Part I—Improving Biosimilar Understanding and Adoption

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

Regulatory Information and Guidance on Biosimilars and Their Use Across Europe: A Call for Strengthened One Voice Messaging

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