Abstract: There are many variables responsible for the pricing of generic medicines in Europe. This editorial looks at the many policy initiatives currently being undertaken. Submitted: 3 November 2011; Revised manuscript received: 23 November 2011; Accepted: 14 December 2011 In this first issue of the Generics and Biosimilars Initiative Journal, Professor Steven Simoens describes the…

Author(s): Associate Professor Marc A Koopmanschap, PhD

DOI: 10.5639/gabij.2012.0101.002

Editor's Letter

Published on 14 February 2012

Introduction to the GaBI Journal

I am proud and pleased to be able to write the introduction to this first issue of the Generics and Biosimilars Initiative Journal (GaBI Journal). This journal is designed to complement GaBI Online which has successfully covered generic and biosimilar issues since 2009. The Publisher, the members of our Editorial Boards, and I, that is, ‘we’;…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2012.0101.001

Contents Editor's Letter What to look forward to in GaBI Journal, 2014, Issue 2 Editorial Complex molecules – current developments Commentary Defining and characterizing nonbiological complex drugs (NBCDs) – Is size enough? The case for liposomal doxorubicin generics (‘liposomal nanosimilars’) for injection Original Research Biosimilars naming, label transparency and authority of choice – survey findings…

Contents Editor’s Letter Latest features in GaBI Journal, 2015, Issue 3 Editorial Advances in analytical characterization of biosimilars Letters to the Editor Access to safe and effective biopharmaceuticals Commentary The challenges of nomenclature – INN, biosimilars and biological qualifiers Review Article Biosimilars patent litigation in the EU and the US: a comparative strategic overview Biosimilars:…

Contents Editor’s Letter What to look forward to in GaBI Journal, 2016, Issue 2 Editorial Adjusted indirect comparisons between generics – bioequivalence and interchangeability Review Article Assessment of the interchangeability between generics  Legal Biosimilars patent litigation in Canada and Japan: a comparative strategic overview and EU and US update Perspective New monoclonal antibody biosimilars approved…

Contents Editor’s Letter Fourth and final issue of GaBI Journal’s fifth volume Editorial Physicians, Hippocrates and biosimilars: applying ancient principles in a modern society Original Research Naming and labelling of biologicals – the perspective of hospital and retail pharmacists Assessment of active pharmaceutical ingredients in drug registration procedures in Pakistan: implications for the future Review…

Contents Editor’s Letter Editor’s introduction to the initial issue of the ninth volume of GaBI Journal Original Research Stability of the trastuzumab biosimilar ABP 980 compared to reference product after intravenous bag preparation, transport and storage at various temperatures, concentrations and stress conditions Pharmaceutical pricing policy in Saudi Arabia: findings and implications Perspective An evolving…

Introduction: The European Union (EU) and the European Medicines Agency (EMA) have led the development of a regulatory framework for biosimilars since 2004. By end of December 2019, 64 biosimilars of 15 originator biological medicines have a marketing authorization in Europe. Now, for the second time, the Alliance for Safe Biologic Medicines (ASBM) asked European…

Author(s): Madelaine A Feldman, MD, FACR, Michael S Reilly, Esq

biological medicines, biosimilar, EU, prescribers, substitution, survey

DOI: 10.5639/gabij.2020.0903.020

Contents Editor’s Letter What to look forward to in GaBI Journal, 2022, Issue 2 Commentary Substitution and interchangeability: time for a conversation? Original Research On statistical evaluation for interchangeability of biosimilar products A case study of AstraZeneca’s omeprazole/esomeprazole chiral switch strategy Review Article Manufacture and regulation of cell, tissue and gene therapy products: global perspectives,…

Opinion

Published on 12 January 2026

Biosimilars: still safe, still effective, still not generics. Why is FDA suddenly pretending they are?

Abstract:The US Health and Human Services (HHS) and the US Food and Drug Administration’s (FDA) new initiative to ‘genericize’ biosimilars by fast-tracking approvals and eliminating key clinical and switching studies represents a radical departure from established global regulatory science. This policy dismisses the foundational distinction between complex biologicals and simple generic drugs—a distinction unanimously upheld by international regulators like…

Author(s): Michael S Reilly, Esq, Professor Philip J Schneider, MS, FASHP, FASPEN, FFIP, Andrew Spiegel, Esq

biosimilars, FDA guidelines, genericization of biosimilars, interchangeable biosimilar, pharmacy substitution, totality of evidence

DOI: 10.5639/gabij.2026.1501.

Contents Editor’s Letter Latest features in GaBI Journal, 2014, Issue 3 Editorial Regional regulatory processes for the approval of biosimilars; differences and similarities Original Research Barriers to market uptake of biosimilars in the US Retrospective chart review: disrupted anaemia control in haemodialysis patients following the switch to an iron sucrose similar (ISS) after long-term treatment…

Contents Editor’s Letter Fourth and final issue of GaBI Journal’s fourth volume Commentary Bioequivalence of narrow therapeutic index drugs and immunosuppressives Original Research Prescribing practices for biosimilars: questionnaire survey findings from physicians in Argentina, Brazil, Colombia and Mexico Perspective Non-Biological Complex Drugs (NBCDs) and their follow-on versions: time for an editorial section Opinion Challenges of…