Interchangeability of Biosimilars: Overcoming the Final Hurdles

Barbier, Liese; Vulto, Arnold G.

doi:10.1007/s40265-021-01629-4

Cited by 13 publications

(9 citation statements)

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“…Data from both randomized controlled trials as well as from observational studies did not corroborate any of the voiced safety concerns with switching ( Cohen et al, 2018 ; Barbier et al, 2020c ). 3) Regulators should provide a more explicit and homogenous scientific position regarding biosimilar interchangeability and (multiple) switching ( Barbier and Vulto, 2021 ; Barbier et al, 2022 ). Similarly, clear and up-to-date position statements from learned healthcare professional and patient associations regarding biosimilar use and switching are paramount in building trust among healthcare professionals ( Somers et al, 2020 ).…”

Section: Discussionmentioning

confidence: 99%

Biosimilar Use and Switching in Belgium: Avenues for Integrated Policymaking

et al. 2022

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Background: By improving the affordability and accessibility of biologicals, biosimilar competition provides important benefits to healthcare systems and patients. In Belgium, biosimilar uptake and competition is limited compared to other European markets. Whereas other countries have initiated structured biosimilar introduction or switching plans, no such framework or guiding principles are yet available in Belgium.Objective: This study aims to develop recommendations that can inform policy action in Belgium on biosimilar use, especially in the context of switch decision-making, and this by drawing from the perspectives of healthcare professionals involved in procuring, prescribing, switching and dispensing biologicals including biosimilars.Methods: This study made use of the consensus-building Nominal Group Technique, consisting of a three-step process 1) individual grading, 2) three structured Focus Group Discussions, 3) final individual grading involving an expert group of Belgian healthcare professionals (physician specialists and hospital pharmacists).Results: Participants (n = 13) voiced challenges with the use of biosimilars and switching in practice, and a lack of incentives to use them. Six concrete areas for policy development to support stakeholders with biosimilar use and switch decision-making were identified: 1) address stakeholder hesitations regarding (multiple) switching, 2) provide meaningful incentives, 3) guide healthcare professionals with product decision-making, 4), align practical product modalities when possible, 5) involve healthcare professionals in policy making, and 6) provide practical switch support and patient information material, particularly in the ambulatory care setting. For each area, specific consensus-based recommendations were developed. Furthermore, a set of switch management and patient communication principles was derived, including amongst others, generating buy-in from involved stakeholders prior to switching and communicating with a one-voice message.Conclusion: Without cohesive actions to reduce hurdles and without tangible benefits or steering mechanisms, changes in biosimilar use are unlikely in Belgium. To overcome this and stimulate market competitiveness, this study advances a set of concrete policy recommendations. At large, policy makers should develop an integrated policy framework, with a pro-active, best-value biological implementation roadmap that provides guidance and compelling measures to incentivize healthcare professionals to use biosimilars. Particular consideration should go to the ambulatory care setting, since drivers for biosimilar use are quasi absent in this context.

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Section: Discussionmentioning

confidence: 99%

Biosimilar Use and Switching in Belgium: Avenues for Integrated Policymaking

et al. 2022

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“…In addition, the concept of loss aversion might also help explain the reluctance among prescribers to transition their patients from the originator biological to a biosimilar. Physicians often fear a decreasing efficacy after transitioning to a biosimilar, as well as a loss of possible informal benefits linked to the original biological (i.e., scientific support, clinical trial involvement) [ 102 – 104 ]. Pharmaceutical promotion is known to be a strong driver to prescribe new medicines [ 105 ].…”

Section: Discussionmentioning

confidence: 99%

Applications of Behavioral Economics to Pharmaceutical Policymaking: A Scoping Review with Implications for Best-Value Biological Medicines

Vandenplas

Simoens

Turk

et al. 2022

Appl Health Econ Health Policy

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Background and Objective Pharmaceutical policies are generally based on the assumption that involved stakeholders make rational decisions. However, behavioral economics has taught us that this is not always the case as people deviate from rational behavior in rather predictable patterns. This scoping review examined to what extent behavioral concepts have already been applied in the pharmaceutical domain and what evidence exists about their effectiveness, with the aim of formulating future applications and research hypotheses on policymaking for best-value biologicals. Methods A scoping literature review was conducted on the evidence of behavioral applications to pharmaceuticals. Scientific databases (Embase, MEDLINE, APA PsycArticles, and Scopus) were searched up to 20 October, 2021. Results Forty-four full-text scientific articles were identified and narratively described in this article. Pharmaceutical domains where behavioral concepts have been investigated relate to influencing prescribing behavior, improving medication adherence, and increasing vaccination uptake. Multiple behavioral concepts were examined in the identified studies, such as social norms, defaults, framing, loss aversion, availability, and present bias. The effectiveness of the applied interventions was generally positive, but depended on the context. Some of the examined interventions can easily be translated into effective policy interventions for best-value biological medicines. However, some applications require further investigation in a research context. Conclusions Applications of behavioral economics to pharmaceutical policymaking are promising. However, further research is required to investigate the effect of behavioral applications on policy interventions for a more sustainable market environment for best-value biological medicines. Supplementary Information The online version contains supplementary material available at 10.1007/s40258-022-00751-y.

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“…The concept of biosimilarity, and especially the fit-for-purpose reduction of clinical studies is difficult to explain to clinicians who are accustomed to rely on clinical trials in the context of new drug development. The mantra "similar but not the same" and "subtle differences" that trigger immune reactions has evoked considerable uncertainty and propelled investments in extensive switch studies (46). Furthermore, regulatory information forms the basis for subsequent coherent and accurate information dissemination on biosimilars and their use more locally.…”

Section: Regulatory Information and Positions On Biosimilars And Thei...mentioning

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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Interchangeability of Biosimilars: Overcoming the Final Hurdles

Cited by 13 publications

References 20 publications

Biosimilar Use and Switching in Belgium: Avenues for Integrated Policymaking

Biosimilar Use and Switching in Belgium: Avenues for Integrated Policymaking

Applications of Behavioral Economics to Pharmaceutical Policymaking: A Scoping Review with Implications for Best-Value Biological Medicines

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

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