The past year has been a busy one for the biosimilars industry. Perhaps one of the most important milestones during 2013 was the European approval of the first monoclonal antibody biosimilar [Remsima/Inflectra (infliximab)] made as a collaboration by South Korean biotechnology company Celltrion and US-based generics major Hospira [1]. Celltrion has also gained approval for…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2014.0301.014

  Abstract: The number of drug shortages in the US has tripled between 2006 and 2012, with drug shortages now affecting most US oncologists and impacting on patient care. There is a need for new guidelines to control drug substitutions and to single out priority populations for relatively scarce drugs. The very real threat of…

Author(s): GaBI Journal Editor

5FU, clinical trials, drug shortages, legislation, oncologists

DOI: 10.5639/gabij.2014.0301.002

Abstract: ‘Non-binding recommendations’ from regulatory bodies are in place for evaluation and production of generic liposomal doxorubicin injection. However, how these nano-sized generics (‘nanosimilars’) should be characterized and evaluated, and particularly when the ‘reference listed product’ is no longer in production are among the major issues. We discuss these issues with respect to complexity of…

Author(s): Professor S Moein Moghimi, PhD, Z Shadi Farhangrazi, PhD

adverse reactions, complement system, immunogenicity, liposomes, nanoparticle size, vesicle morphology

DOI: 10.5639/gabij.2014.0302.017

Abstract: Although not derived from living sources, non-biological complex drug (NBCD) products have the immunogenicity and molecular complexity of biological drugs. NBCDs typically contain heterogenous mixtures of closely related nanoparticulate components that cannot be isolated, quantified, or entirely characterized physicochemically. Development of follow-on versions of NBCDs poses many of the same scientific challenges associated with…

Author(s): J Michael Nicholas, PhD

follow-on drugs, glatiramoids, iron-carbohydrate complexes, liposomes, non-biological complex drug (NBCD)

DOI: 10.5639/gabij.2014.0302.020

Author byline as per print journal: Professor Jacques Rottembourg, MD; Corinne Emery, MSc; Alessandra Moglia, PhD Study objective: To describe and compare the haematological parameters and the anaemia medication use in haemodialysis patients who were switched from the originator iron sucrose (IS) to an iron sucrose similar (ISS). Methods: A retrospective observational single-centre study describing chronic…

Author(s): Alessandra Moglia, PhD, Corinne Emery, MSc, Jacques Rottembourg, MD

anaemia, cost, haemodialysis, interchangeability, iron sucrose, iron sucrose similar, non-biological complex drug (NBCD), oxidative stress

DOI: 10.5639/gabij.2014.0303.029

Abstract: Two biosimilar TNF-alfa monoclonal antibody (mAb) products were approved for clinical use in the European Union on 10 September 2013, following a positive opinion by the Committee for Medicinal Products for Human Use (CHMP) in July 2013. The products, with trade names Remsima and Inflectra (INNs infliximab) contain an identical mAb. This approval shows…

Author(s): Meenu Wadhwa, PhD, Robin Thorpe, PhD, FRCPath

biosimilar, EPAR, infliximab, monoclonal antibodies

DOI: 10.5639/gabij.2014.0301.004

Author byline as per print journal: Steven Simoens, PhD; Claude Le Pen, PhD; Niels Boone, PharmD; Ferdinand Breedveld, MD, PhD; Antonella Celano; Antonio Llombart-Cussac, MD, PhD; Frank Jorgensen, MPharm, MM; Andras Süle, PhD; Ad A van Bodegraven, MD, PhD; Rene Westhovens, MD, PhD; Jo De Cock Introduction/Objectives: This manuscript aims to provide guidance to policymakers with…

Author(s): Ad A van Bodegraven, MD, PhD, Andras Süle, PhD, Antonella Celano, Antonio Llombart Cussac, MD, PhD, Frank Jorgensen, MPharm, MM, Jo De Cock, Niels Boone, PharmD, Professor Claude Le Pen, PhD, Professor Ferdinand Breedveld, MD, PhD, Rene Westhovens, MD, PhD, Steven Simoens, MSc, PhD

biologicals, biosimilars, competition, Europe, policy, sustainability

DOI: 10.5639/gabij.2018.0702.014

Abstract: As the number of innovator biologics and biosimilars increases worldwide, a growing debate has focused on how these products should be named. The simple concept of a name can have significant impact on prescribing, dispensing, and adverse event reporting processes and, consequently, patient safety. Submitted: 2 January 2014; Revised: 10 January 2014; Accepted: 11…

Author(s): Emily A Alexander, JD

adverse event reporting, biosimilars, naming

DOI: 10.5639/gabij.2014.0301.005

Abstract: For harmonization of the authorization requirements for specific generic applications within the EU, consistent criteria were drafted for 16 active substances, which are out now for public consultation. Submitted: 2 January 2014; Revised: 6 January 2014; Accepted: 7 January 2014; Published online first: 20 January 2014 Official draft guidance has recently become available for…

Author(s): Christoph Baumgärtel, MD, MSc

authorization, bioequivalence, generics, product-specific bioequivalence guidance

DOI: 10.5639/gabij.2014.0301.009

Introduction: Many regulatory authorities have published requirements for the approval of biosimilar medicinal products. However, there is no guidance on which quantitative standards should be used to define how similar a follow-on product must be to be considered biosimilar. Sample sizes for clinical biosimilar trials using traditional designs often exceed 500 patients. Several publications have…

Author(s): Austin J Combest, PharmD, MBA, Song Wang, PhD, Brian T Healey, PharmD, MS, MBA, RAC, Dirk J Reitsma, MD

Bayesian design, biosimilar, drug development, repeated measures analysis, statistics strategy

DOI: 10.5639/gabij.2014.0301.006

The European Medicines Agency recommends the use of pharmacodynamics (PD) markers when establishing biosimilarity, but no such biomarkers are known for the clinical efficacy of bevacizumab (Avastin). For this reason, confirmatory clinical efficacy studies are essential, write Hans Ebbers et al. of Utrecht University in The Netherlands [1]. The biosimilar monoclonal antibodies (mAb) guideline released…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2014.0301.013

Editor's Letter

Published on 05 December 2013

GaBI Journal publishes four issues in 2013

This issue marks the forth and final issue of the second year’s edition of the GaBI Journal. The journal has grown rapidly through the combined efforts of the publisher and her staff, all of the members of the executive editorial board and the international editorial advisory board, our contributors, advertisers and readers for which I…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2013.0204.042