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…

Contents Editor’s Letter What to look forward to in GaBI Journal, 2015, Issue 2 Commentary Pro-generics policies and the backlog in medicines registration in South Africa: implications for access to essential and affordable medicines Original Research Product naming, pricing, and market uptake of biosimilars Differences in pharmacokinetic behaviour of branded enoxaparin and a US generic version in a non-human primate model Pharmaceutical pricing…

Contents Editor’s Letter Fourth and final issue of GaBI Journal’s seventh volume Editorial Nomenclature for biosimilars; a continuing thorny issue Original Research Ongoing activities to influence the prescribing of proton pump inhibitors within the Scottish National Health Service: their effect and implications Review Article The need for distinct nomenclature for originator and biosimilar products Meeting…

Contents Editor’s Letter What to look forward to in GaBI Journal, 2020, Issue 2 Commentary Importance of the determination of the higher order structure in the in-use stability studies of biopharmaceuticals Review Article Global challenges in the manufacture, regulation and international harmonization of GMP and quality standards for biopharmaceuticals Current trends for biosimilars in the…

Editor's Letter

Published on 10 September 2024

What to look forward to in GaBI Journal, 2024, Issue 2

Issue 2 of Volume 13 of GaBI ­Journal starts with a Review Article by Paul et al., titled ‘Increasing adoption of quality-assured biosimilars to address access challenges in low- and middle-income countries’. The review focuses on treatment of non-communicable diseases as these disproportionately affect people living in low- and middle-income countries compared to high-income countries. Challenges…

Author(s): Robin Thorpe, PhD, FRCPath

DOI: 10.5639/gabij.2024.1302.007

Contents Editor’s Letter What to look forward to in GaBI Journal, 2017, Issue 2 Editorial Trends and challenges in biosimilars pricing and reimbursement policies in Europe and beyond Commentary Strategies for pricing of pharmaceuticals and generics in developing countries Original Research What pricing and reimbursement policies to use for off-patent biologicals in Europe? – results…

Abstract: Iran was the first country in the MENA (Middle East and North Africa) region to publish a legal framework for the registration of biosimilars. This framework is defined by the Iranian Food and Drug Administration (IFDA). It defines biosimilars as biological products that have the same Active Pharmaceutical Ingredient (API) as the Reference Medicinal…

Author(s): Jalal Naeli, MD

biopharmaceuticals, Iran, reference medicinal product

Contents Editor’s Letter First 2021 GaBI Journal issue highlights Original Research Biosimilars – status in July 2020 in 16 countries An assessment of trends in the Iranian pharmaceutical market following domestic production of selected medications (2007‒2017) and new considerations for health policymakers Review Article Continuous manufacturing versus batch manufacturing: benefits, opportunities and challenges for manufacturers…

Table Contents

Published on 15 April 2024

2024/1 GaBI Journal Table of Contents

Editor’s Letter First 2024 GaBI Journal issue highlights Original Research Budget impact analysis of a rituximab intravenous biosimilar in patients with follicular lymphoma and large B-cell non-Hodgkin lymphoma in Chile Pharmacokinetic bioequivalence studies of a new Etoricoxib tablet formulation developed using proprietary MiST technology — risk assessment and mitigation using GastroPlus software Perspective Comparative efficacy…

Contents Editor’s Letter Fourth and final issue of GaBI Journal’s third volume Editorial Availability and procurement of generics in hospitals among medium-sized European countries Letters to the Editor Access to alternative biopharmaceuticals in low- and middle- income countries Commentary Biosimilars versus ‘biobetters’ — a regulator’s perspective Original Research Availability and procurement conditions of originator and…