Author byline as per print journal: Hillel P Cohen, PhD; Caridad Pontes, MD, PhD; Fernando de Mora, MBA, PhD

Submitted: 20 December 2024; Revised: 6 January 2025; Accepted: 8 January 2025; Published online first: 14 January 2025

Comment on ‘Misinformation about interchangeable biosimilars undermines US health policy, physician confidence, and patient health’ (GaBI Journal, 2024;13(2):55-60)

Dear Editor,

We have concerns about an article from Reilly and McKibben entitled ‘Misinformation about interchangeable biosimilars undermines US health policy, physician confidence, and patient health’ that was published in GaBI Journal on 15 July 2024 [1]. In this article Reilly and McKibben criticize the meta-analysis published by Herndon et al. [2] and conclude that the conclusions reached by Herndon et al. are not supported by the data. We believe that there are numerous severe factual errors within Reilly and McKibben that question their conclusions.

Reilly and McKibben warn the readers about what they consider a reduction of the quality standards required by the US Food and Drug Administration (FDA) for a biosimilar being awarded the interchangeability designation. The authors fundamentally claim that interchangeability, which in the US refers to the possibility for the pharmacist to dispense either the biosimilar or the originator without the prescriber’s intervention, should rely on pre-authorization switching studies in patients. The underlying view of the publication is that allowing pharmacists to foster transition from the originator to the biosimilar in a given patient without such studies having been conducted, may put the patient at an unexpected safety risk.

First and foremost, the publication does not accurately portray the science of ‘biosimilarity’ and of the evidence needed to warrant safety of the ‘exchange’ between the original reference biological and a biosimilar.

The authors do not acknowledge that the concepts of analytical and functional similarity are the key facts underpinning biosimilar and interchangeability [3, 4].  Drugs with the same structure and function, by definition, will have the same clinical impact, including efficacy and safety events [5-7]. Instead, Reilly and McKibben focus on the meta-analysis published by Herndon et al. as if the clinical data evaluated in the meta-analysis were the sole basis supporting single and multiple switches between reference product and biosimilar.

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This manuscript has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process, which may lead to differences between this version and the Version of Record.