Analysis of Pharmacokinetic and Pharmacodynamic Parameters in EU- Versus US-Licensed Reference Biological Products: Are In Vivo Bridging Studies Justified for Biosimilar Development?

Tu, Chien Lung; Wang, Yi Lin; Hu, Teh Min; Hsu, Li-Feng

doi:10.1007/s40259-019-00357-2

Cited by 10 publications

(8 citation statements)

References 33 publications

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“…We commend Tu et al [2] for their paper, which confronts the same problem and supports by careful data analysis our contention that costly and duplicative studies are unnecessary to qualify a comparator for permitted studies when the terms of our proposed evidentiary basis are satisfied. However, in their comments on our paper, the authors stated,“Post-approval manufacturing changes or production site transfers were tightly controlled by regulatory authorities and the consistency between pre- and post-changed products were evaluated using the same principles and guidelines (e.g., International Conference on Harmonisation Q5E) adopted by most countries worldwide.…”

mentioning

confidence: 53%

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Comment on “Analysis of Pharmacokinetic and Pharmacodynamic Parameters in EU-Versus US-Licensed Reference Biological Products: Are In Vivo Bridging Studies Justified for Biosimilar Development?”

Webster¹,

Woollett

2019

BioDrugs

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mentioning

confidence: 53%

“…We wish to respond to commentary about our paper [1], “A ‘Global Reference’ Comparator for Biosimilar Development,” made in the article by Tu et al [2] recently published in BioDrugs .…”

mentioning

confidence: 99%

Comment on “Analysis of Pharmacokinetic and Pharmacodynamic Parameters in EU-Versus US-Licensed Reference Biological Products: Are In Vivo Bridging Studies Justified for Biosimilar Development?”

Webster¹,

Woollett

2019

BioDrugs

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“…This is akin to the situation wherein the second innovator product of two reference products—manufactured and approved in highly regulated yet different jurisdictions (e.g., EU and USA)—is essentially an nth-generation biosimilar of the product approved originally, as they share a common origin (i.e., they are based on the same drug and the same types of clinical trials). Some contend that bridging studies required to formally prove biosimilarity between local and international reference products are unnecessary and should be waived [ 94 , 95 ]. Understanding the scientific principles underpinning biosimilarity should provide a dependable basis for the intersection of other considerations that must be weighed by physicians exploring the feasibility of a biosimilar cross-switch.…”

Section: Biosimilar Switching Requires An Educated Decisionmentioning

confidence: 99%

Biosimilar-to-Biosimilar Switching: What is the Rationale and Current Experience?

Mysler¹,

Azevedo

Danese

et al. 2021

Drugs

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Over time, clinicians have become increasingly comfortable embracing the prescription of biosimilars-highly similar versions of innovator or reference biological agents-for their patients with inflammatory diseases. Although a switch from a reference product to a licensed biosimilar version (or vice versa) is a medical decision robustly supported by the stepwise accumulation of clinical trial evidence concerning comparable safety, immunogenicity, and efficacy between these products, a switch from one biosimilar to another biosimilar of the same reference product, or a cross-switch, is not. Similarity among biosimilars of a reference product is not a regulatory agency concern and therefore is unlikely to be investigated in randomized controlled trials in the foreseeable future. Yet in clinical practice, across a diverse range of patients, the option to cross-switch from one biosimilar to another can and does arise for valid reasons such as convenience or tolerability issues, or driven by third parties (e.g., payers). In the absence of clinical trial data, clinicians must attempt to objectively evaluate the emerging real-world cross-switching evidence within the context of what is known about the science underpinning a designation of biosimilar. That knowledge then needs to be integrated with what clinicians know about their patients and their disease on a case-by-case basis. This review aims to consolidate relevant emerging real-world data and other key information about biosimilar-to-biosimilar cross-switching for prescribing clinicians. In the absence of clear clinical guidelines addressing this topic at present, this review may serve to facilitate discretionary and educated treatment decision making.

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“…These limits did not originate from studies of biologics but from equivalence studies with small-molecule drugs, and experience with biosimilars indicates that most lie within substantially closer limits to their references [45]. However, the pharmacokinetics of several comparisons have fallen outside the acceptance limits, but, rather than preventing approval of the product, this has usually been attributed to some cause of inaccuracy and the data either accepted or the study re-run [44][45][46]. Despite their use, it is unknown whether these generic drug limits are optimal for the characterization of biologics.…”

Section: Requirements For Clinical Datamentioning

confidence: 99%

Comparability of Biologics: Global Principles, Evidentiary Consistency and Unrealized Reliance

Webster¹,

George

Woollett

2021

BioDrugs

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The principles of comparability assessments have been accepted globally as offering sensitive and reliable tools with which to evaluate potential changes to biologics that may arise either through processing changes or through the creation of a copy (biosimilar) by a different sponsor. The comparability approach has evolved through systematic advances in four areas: clear and convergent guidelines for evaluation of potential changes to biologics; risk-based systems of weighting analytical data; progressive improvements in analytical methods; and advanced understanding of post-translational modifications. Routine regulatory expectations for clinical equivalence data are being reevaluated, as they seldom contribute to the assessment of similarity. Similarly, we show that requirements to compare biosimilars and locally sourced versions of their reference products are of questionable scientific value and represent a double standard by comparison with the invariable acceptance of the clinical profiles of novel biologics without reference to their sources. The consistent application of evidentiary standards for comparability to all biologics offers an opportunity for regulators to curtail their own assessments of new biosimilars and instead to recognize comparability assessments made in another jurisdiction (reliance), thereby gaining important efficiencies in the regulatory review of biosimilars and improving the competitiveness of the biosimilars market. Such consistency can also enhance the confidence of all stakeholders, especially patients and their providers, in all biologics.

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Analysis of Pharmacokinetic and Pharmacodynamic Parameters in EU- Versus US-Licensed Reference Biological Products: Are In Vivo Bridging Studies Justified for Biosimilar Development?

Cited by 10 publications

References 33 publications

Comment on “Analysis of Pharmacokinetic and Pharmacodynamic Parameters in EU-Versus US-Licensed Reference Biological Products: Are In Vivo Bridging Studies Justified for Biosimilar Development?”

Comment on “Analysis of Pharmacokinetic and Pharmacodynamic Parameters in EU-Versus US-Licensed Reference Biological Products: Are In Vivo Bridging Studies Justified for Biosimilar Development?”

Biosimilar-to-Biosimilar Switching: What is the Rationale and Current Experience?

Comparability of Biologics: Global Principles, Evidentiary Consistency and Unrealized Reliance

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