Monoclonal Antibody Biosimilars in Oncology: Critical Appraisal of Available Data on Switching

Declerck, Paul; Bakalos, Georgios; Ζιντζαράς, Ηλίας; Barton, Bettina; Schreitmüller, Thomas

doi:10.1016/j.clinthera.2018.03.018

Cited by 23 publications

(26 citation statements)

References 16 publications

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“…This systematic literature review aims to synthesize the currently available data on switching and to assess the safety, immunogenicity, and efficacy of switching between RPs and their respective biosimilar version(s). This review broadens the scope of previous studies 14,17 by reviewing switch data for biologicals of every therapeutic class for which a European market authorization has been granted, more specifically: (i) recombinant human growth hormones (rhGHs), (ii) erythropoietins, (iii) granulocyte colony stimulating agents, (iv) insulins, (v) tumor necrosis factor alpha inhibitors (anti-TNFs), (vi) gonadotropins, (vii) low-molecular-weight heparins, and (viii) mAbs used in oncology. Further, we aim to provide a critical insight on the current state-of-the-art related to switching.…”

Section: Key Concepts and Terminologymentioning

confidence: 76%

“…2 Further, other reviews have been conducted but these mostly focussed on one specific product class or therapeutic area. 17,70,71 Two other systematic literature reviews (McKinnon and Cohen 72,73 ) have been published that included switch studies derived from multiple product classes and disease areas. Switch studies were included until June of 2017 in these reviews.…”

Section: Current Switch Evidence -Learnings and Considerationsmentioning

confidence: 99%

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

Barbier

Ebbers

Declerck

et al. 2020

Clin Pharma and Therapeutics

Self Cite

102

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To date, no consensus exists among stakeholders about switching patients between reference biological products (RPs) and biosimilars, which may have been curbing the implementation of biosimilars in clinical practice. This study synthesizes the available data on switching and assesses whether switching patients from a RP to its biosimilar or vice versa affects efficacy, safety, or immunogenicity outcomes. A total of 178 studies, in which switch outcomes from a RP to a biosimilar were reported, was identified. Data were derived from both randomized controlled trials and real‐world evidence. Despite the limitations stemming from a lack of a robust design for most of the studies, the available switching data do not indicate that switching from a RP to a biosimilar is associated with any major efficacy, safety, or immunogenicity issues. Some open‐label and observational studies reported increased discontinuation rates after switching, which were mainly attributed to nocebo effects. Involvement of the prescriber in any decision to switch should remain and attention should be paid to the mitigation of a potential nocebo effect.

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Section: Key Concepts and Terminologymentioning

confidence: 76%

Section: Current Switch Evidence -Learnings and Considerationsmentioning

confidence: 99%

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

Barbier

Ebbers

Declerck

et al. 2020

Clin Pharma and Therapeutics

Self Cite

102

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“…Generics and biosimilars can help to improve the cost‐effectiveness of cancer drugs and make them accessible to more patients . Table summarizes the differences between generics and biosimilars.…”

Section: Approaches To Decreasing Cancer Medicine Costsmentioning

confidence: 99%

Enhancing global access to cancer medicines

Cortés

Peréz-García

Llombart-Cussac

et al. 2020

CA A Cancer J Clinicians

143

108

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Globally, cancer is the second leading cause of death, with numbers greatly exceeding those for human immunodeficiency virus/acquired immunodeficiency syndrome, tuberculosis, and malaria combined. Limited access to timely diagnosis, to affordable, effective treatment, and to high‐quality care are just some of the factors that lead to disparities in cancer survival between countries and within countries. In this article, the authors consider various factors that prevent access to cancer medicines (particularly access to essential cancer medicines). Even if an essential cancer medicine is included on a national medicines list, cost might preclude its use, it might be prescribed or used inappropriately, weak infrastructure might prevent it being accessed by those who could benefit, or quality might not be guaranteed. Potential strategies to address the access problems are discussed, including universal health coverage for essential cancer medicines, fairer methods for pricing cancer medicines, reducing development costs, optimizing regulation, and improving reliability in the global supply chain. Optimizing schedules for cancer therapy could reduce not only costs, but also adverse events, and improve access. More and better biomarkers are required to target patients who are most likely to benefit from cancer medicines. The optimum use of cancer medicines depends on the effective delivery of several services allied to oncology (including laboratory, imaging, surgery, and radiotherapy). Investment is necessary in all aspects of cancer care, from these supportive services to technologies, and the training of health care workers and other staff.

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“…Assessing the effects of switching in a "real-world" setting can be challenging, as patients may be switched back and forth among different products in clinical practice [23]. Observational studies of the use of epoetins and granulocyte colony-stimulating factors in patients with chronic kidney disease or cancer in Italy have demonstrated that there is frequent switching between different biological products belonging to the same class in routine clinical care [24,25].…”

Section: Current Evidence On the Effects Of Switchingmentioning

confidence: 99%

Interchangeability of Biosimilars: What Level of Clinical Evidence is Needed to Support the Interchangeability Designation in the United States?

et al. 2020

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A biosimilar is a biologic drug that is "highly similar to a reference (originator) product, with no clinically meaningful differences between the two products in safety, purity, and potency". Regulatory approval of a biosimilar is based on analytical, structural, and functional comparisons with the reference product, comparative nonclinical (in vivo) studies, clinical pharmacokinetics and/or pharmacodynamics, and immunogenicity. In addition, comparative clinical efficacy and safety assessments are usually conducted and, taken together, comprise the "totality of the evidence" supporting biosimilarity. For a biosimilar to meet the additional designation of interchangeability in the United States (US), the applicant must demonstrate that the biological drug can be expected to produce the "same clinical result as the reference product in any given patient" and "if the biological drug is administered more than once to an individual, the risk in terms of safety or diminished efficacy of alternating or switching between the use of the biological drug and the reference product is no greater than the risk of using the reference product without such alternation or switch". The challenges faced in conducting clinical studies to support a designation of interchangeability, as defined in the final interchangeability guidance from the US Food and Drug Administration, are considered. Potential alternative approaches to generating adequate and sufficient clinical data to support a designation of interchangeability are also presented.

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Monoclonal Antibody Biosimilars in Oncology: Critical Appraisal of Available Data on Switching

Abstract: From the scarce data available, the consequences of switching between reference product mAbs and their biosimilar(s) in the oncology setting are as yet unknown. Additional clinical evidence from well-designed switching studies is needed to guide switching decisions.

Cited by 23 publications

References 16 publications

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

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

Enhancing global access to cancer medicines

Interchangeability of Biosimilars: What Level of Clinical Evidence is Needed to Support the Interchangeability Designation in the United States?

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