The Efficacy, Safety, and Immunogenicity of Switching Between Reference Biopharmaceuticals and Biosimilars: A Systematic Review

Barbier, Liese; Ebbers, Hans C.; Declerck, Paul; Simoens, Steven; Vulto, Arnold G.; Huys, Isabelle

doi:10.1002/cpt.1836

Cited by 111 publications

(116 citation statements)

References 66 publications

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“…In line with findings from the considerable number of switch studies conducted over recent years [ 10 , 11 ], the interviewed experts largely considered switching from a reference product to a biosimilar to be a part of clinical care. However, stakeholders indicated a need for guidance regarding multiple switching, as regulatory guidance predominantly focusses on a single switch from a reference product to a biosimilar, and a harmonized regulatory position about interchangeability across Europe is lacking [ 10 , 11 , 18 ]. A clear Europe-wide one-voice regulatory position about interchangeability and switching is required to support stakeholders faced with switch decisions in Europe.…”

Section: Discussionmentioning

confidence: 85%

“…Several randomized, controlled and real-world studies have evaluated the efficacy, safety, and immunogenicity of switching from reference products to biosimilars. Overall, the vast majority of studies did not indicate any major safety, efficacy, or immunogenicity issues associated with this [ 10 , 11 ]. However, a number of real-world studies have reported a relatively high therapy discontinuation rate among patients after switching, which was mostly attributed to the occurrence of the nocebo effect [ 10 ].…”

Section: Introductionmentioning

confidence: 99%

“…Overall, the vast majority of studies did not indicate any major safety, efficacy, or immunogenicity issues associated with this [ 10 , 11 ]. However, a number of real-world studies have reported a relatively high therapy discontinuation rate among patients after switching, which was mostly attributed to the occurrence of the nocebo effect [ 10 ]. The nocebo effect is defined as a negative impact on the patient’s perceived treatment outcome resulting from the patient’s negative expectation about the (change in) therapy [ 12 , 13 ].…”

Section: Introductionmentioning

confidence: 99%

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European Stakeholder Learnings Regarding Biosimilars: Part II—Improving Biosimilar Use in Clinical Practice

et al. 2020

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Background Despite the benefits biosimilars offer in terms of cost savings and patient access, healthcare professionals and patients have been reluctant to use them. Next to insufficient understanding of and trust in biosimilars, healthcare professionals and patients have questions about switching and the nocebo effect when using biosimilars in clinical practice. In addition, clear motivation to use biosimilars may be lacking among these stakeholders. Objective This study aims to provide recommendations on how to improve biosimilar use on both a clinical and a practical level based on insights from healthcare professionals (physicians, hospital pharmacists, nurses), patients (or their representatives), and regulators across Europe. Methods We conducted 44 semi-structured interviews with experts from five stakeholder groups across Europe: physicians, hospital pharmacists, nurses, regulators, and patients/representatives. Interviews were transcribed ad verbatim and transcripts analysed according to the thematic framework method. Results Based on the insights and considerations of the experts interviewed, we identified a number of recommendations to improve the use of biosimilars in clinical practice. Regarding switch implementation, the experts voiced support for the following actions: (1) disseminate evidence from and experience with (multiple) switching; (2) provide clear, one-voice regulatory guidance about the interchangeability of biosimilars and their reference product; (3) apply a multi-stakeholder implementation and communication protocol to guide switching in clinical practice; (4) apply a pragmatic approach when taking switch decisions; and (5) avoid mandated switching, allowing stakeholder communication and alignment. When discussing approaches to increase the willingness of stakeholders to use biosimilars, we concluded that actions should be centred on (1) communicating the benefits provided by biosimilars and the introduction of market competition, (2) increasing awareness among stakeholders about medicine prices and their societal responsibility to use medicines in a cost-effective manner, (3) transparent reporting about the allocation of savings, (4) sharing biosimilar usage data among hospitals and prescribers to allow peer-to-peer benchmarking, and (5) applying a balanced combination of tangible and non-tangible incentives that can be tailored to offset the time and effort expended by stakeholders when switching to a biosimilar. Conclusions This study proposes a number of strategic, practical, and overarching recommendations to support healthcare professionals and inform decision makers to improve the clinical use of biosimilars and the willingness of stakeholders to use them. The proposed solutions to fully realise the potential of biosimilars for healthcare systems and patients include developing practical switch guidance, being transparent about the gains from bios...

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Section: Discussionmentioning

confidence: 85%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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European Stakeholder Learnings Regarding Biosimilars: Part II—Improving Biosimilar Use in Clinical Practice

et al. 2020

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“…An article on the ethics of biosimilars [ 33 ] cited three literature reviews [ 34 – 36 ] to conclude that the safety and efficacy of switching once from a reference product to a biosimilar is still controversial, and therefore physicians are ethically obligated to inform prospective biosimilar recipients of this “fact.” However, a close examination of the three reviews found that none of them identified any specific safety or lack of efficacy concern related to switching once from a reference biologic to a biosimilar. Another recent review of 178 switching studies also concluded that for the products studied, a single switch is not intrinsically linked to an increase in immunogenicity, safety, or efficacy issues [ 37 ]. Nonetheless, the “fact” that there is a supposed controversy about the practice of switching from a reference biologic to a biosimilar was cited by another publication as part of a set of arguments against a Canadian provincial policy of switching from reference infliximab to biosimilar infliximab [ 38 ].…”

Section: Types Of Biosimilar Disparagement and Misinformationmentioning

confidence: 99%

The Importance of Countering Biosimilar Disparagement and Misinformation

Cohen¹,

McCabe

2020

BioDrugs

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Biosimilar use is limited in some healthcare systems because biosimilars are not well understood by many healthcare professionals and patients. The knowledge gap is exacerbated by disparagement of biosimilars and dissemination of misinformation, whether intentional or otherwise. There are several different types of disparagement and misinformation directed towards biosimilars as a class, including statements about biosimilar science or policy that are factually incorrect; misleading information, where the information is correct, but is provided out of context; incomplete information, where only partial or a limited set of facts are provided; creation of a false narrative, especially in scientific and medical literature, that provides a set of references to support incorrect conclusions; and negative message framing of factual statements to create a negative perception. Disparagement and misinformation about biosimilars can be countered by educational efforts, appropriate oversight, and regulatory activities with the option of enforcement action by governmental agencies, if warranted. Balanced educational materials about biosimilars should be made easily accessible. Physicians, nurses, pharmacists, and patient advocacy groups should work together to provide patients with consistent, positive messages about the value of biosimilars.

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“…prior to the start of a biological treatment or during prolonged treatment) and policies related to interchangeability. For instance, there are multiple levels at which switching can be enacted: by the physician, by the pharmacist, or by the healthcare system (Barbier et al, 2020). Recommendations could clarify cases in which the switch should be under the responsibility of the treating physician, cases in which the patient can safely switch among biologic and biosimilar medicines (e.g.…”

Section: Implications For the Model List For The 2021 Updatementioning

confidence: 99%

The “Square Box”: Therapeutic Equivalence as a Foundation of the WHO Model List of Essential Medicines

et al. 2020

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Every two years, the World Health Organization (WHO) updates its Model List of Essential Medicines, intended as a guide for countries to adopt or adapt in accordance with local priorities and treatment guidelines, for the development of national essential medicines lists. When more than one therapeutic option is available for a given indication, the WHO Model List often includes a single medicine as representative of a group of equivalent and interchangeable medicines. The representative medicine of that group is listed with an accompanying 'square box' symbol. The intended purpose of the square box is to highlight pharmacological classes or groups of medicines for which countries, institutions and health professionals can assume homogeneous therapeutic efficacy and safety and select the most appropriate single medicine based on price, local availability, and acceptability. Though this concept of therapeutic equivalence within a therapeutic class has been endorsed by most authoritative textbooks of pharmacology since Goodman & Gilman's The Pharmacological Basis of Therapeutics and evidence-based guidelines, marketing forces have often made claims on individual drugs to distinguish them beyond relevant differences shown by reliable evidence: this has generated the concept of "metoo drugs" with its double meaning-i.e., market latecomers differing minimally from products preceding them and whose marketing budgets have significant opportunity costs, or medicines which may be useful to substitute for equivalent products in the event of shortages. The square box concept is applied in the context of a comprehensive list: therapeutic equivalence or interchangeability cannot always be easily established. Different interpretations have been applied to different groups of medicines over the 40+ year history of the Model List. This paper presents the concept of the square box, provides key examples and guidance on how square box listings should be practically interpreted in the development and implementation of national essential medicine lists, considers the applicability of a square box listing concept to biologic medicines and proposes that an updated review of the square box concept and listings is warranted.

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The Efficacy, Safety, and Immunogenicity of Switching Between Reference Biopharmaceuticals and Biosimilars: A Systematic Review

Cited by 111 publications

References 66 publications

European Stakeholder Learnings Regarding Biosimilars: Part II—Improving Biosimilar Use in Clinical Practice

European Stakeholder Learnings Regarding Biosimilars: Part II—Improving Biosimilar Use in Clinical Practice

The Importance of Countering Biosimilar Disparagement and Misinformation

The “Square Box”: Therapeutic Equivalence as a Foundation of the WHO Model List of Essential Medicines

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