Editor’s introduction to the initial issue of the 14th volume of GaBI Journal
Published on 2025/04/10
Generics and Biosimilars Initiative Journal (GaBI Journal). 2025;14(1):3.
In this first issue of 2025, we have some controversial criticism of an article previously published in GaBI Journal [1}, as well as a paper on pricing of biosimilars/biologicals after patent expiry and a meeting report on claimed weakening of FDA regulatory standards for biosimilars and its perceived effects on undermining physician confidence in biosimilar products. The issue contains no articles on chemical generics, and we encourage potential authors to submit papers to GaBI Journal on this very important class of product, as well as articles on biosimilars.
The issue starts with two Letters to the Editor criticizing and challenging the information presented in the same article namely ‘Misinformation about interchangeable biosimilars undermines US health policy, physician confidence, and patient health’ by Reilly MS and McKibbin RD published in GaBI Journal, 2024, Issue 2 [1].
The first of these letters, titled ‘Comment on the article by Reilly MS and McKibbin RD’ by Adjunct Professor Pekka Kurki, a distinguished contributor to GaBI Journal and other international journals on the topic of biosimilars, disputes the arguments put forward in the criticized article and, in my view very reasonably, concludes that they lack a scientific basis.
The second letter titled ‘Comment on the article ‘Misinformation about interchangeable biosimilars’ by Drs Hillel P Cohen, Caridad Pontes and Fernando de Mora again points out many issues and problems with the article by Mr Reilly and Dr McKibbin and concludes that these authors’ claim that the meta-analysis conducted by Herndon et al. [2] is factually flawed on several important points is incorrect and that as a result of this and other problems, the conclusions of Reilly and McKibben are not scientifically substantiated and are in fact erroneous.
The Original Research paper in this issue is titled ‘An analysis of policy impacts on the price developments of biological medicines after patent expiration’ and is authored by Dr Peter Schneider, Mr Alexander Guggenberger, Dr Siegfried Eisenberg and Mr Lukas Rainer. Data on monthly prices of nine biological active ingredients (adalimumab, enoxaparin, etanercept, infliximab, insulin glargine, insulin lispro, pegfilgrastim, rituximab, trastuzumab) were collected. In addition to price information, data on: (a) medicines; (b) policy measures; and (c) other characteristics of examined countries was gathered. The results highlighted the significant impact of supply-side pricing policies, whereas demand-side measures did not foster a more competitive environment for biological medicines and have yet not lead to substantial price reductions.
The Meeting Report describes a webinar titled ‘Biosimilar Red Tape Elimination Act (S.2305): weakening FDA regulatory standards for biosimilars, undermining physician confidence and jeopardizing patient health’, which was held on 31 October 2024. It was held by the Alliance for Safe Biologic Medicines (ASBM) in collaboration with Generics and Biosimilars Initiative and the report is authored by Mr Michael S Reilly, Dr Ralph D McKibbin, Professor Philip J Schneider and Mr Andrew Spiegel. The webinar facilitated an in-depth discussion about Biosimilar Red Tape Elimination Act and highlighted its perceived shortcomings, particularly regarding the designation of all biosimilars as interchangeable.
Robin Thorpe, PhD., FRCPath
Editor-in-Chief, GaBIJournal
References
1. Reilly MS, McKibbin RD. Misinformation about interchangeable biosimilars undermines US health policy, physician confidence, and patient health. Generics and Biosimilars Initiative Journal (GaBI Journal). 2024;13(2):55-60. doi:10.5639/gabij.2024.1302.009
2. Schrieber S. Switches between biosimilars and their reference products. Generics and Biosimilars Initiative Journal (GaBI Journal). 2023;12(3):106. doi:10.5639/gabij.2023.1203.016
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