Author byline as per print journal: Niels Eckstein, PhD; Lea Röper, BSc; Bodo Haas, PhD; Henrike Potthast, PhD; Ulrike Hermes, PhD; Christoph Unkrig, MD; Frauke Naumann-Winter, PhD; Harald Enzmann, MD Aim: To provide a systematic overview on: i) safety profiles; ii) pharmacokinetic parameters; and iii) regulatory framework of anti-cancer tyrosine kinase inhibitors (TKI). Methodology: Recherché of pharmakokinetic (PK)-parameter: i) Germany’s federal drug database…

Author(s): Bodo Haas, PhD, Christoph Unkrig, MD, Frauke Naumann-Winter, PhD, Harald Enzmann, MD, Henrike Potthast, PhD, Lea Röper, BSc, Niels Eckstein, PhD, Ulrike Hermes, PhD

generics, narrow therapeutic index drugs, orphan drugs, product-specific bioequivalence guidance, tyrosine kinase inhibitors (TKI)

DOI: 10.5639/gabij.2014.0302.021

The International Alliance of Patients’ Organizations (IAPO) is an alliance of over 200 patient groups that represents the interests of patients worldwide. In November 2013, IAPO published its Information and Advocacy Toolkit on Biological and Biosimilar Medicines for Patients’ Organizations [1]. The Toolkit was developed to provide up-to-date, evidence-based information on the science, technology, and…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2014.0304.045

Abstract: The principles Health Canada use when extrapolating the indications and uses of a biosimilar product subsequent to a single clinical trial or limited number and scope of clinical trials during product development are discussed. The principles underlying the regulatory framework for subsequent entry biologics (SEBs or biosimilars) in Canada explain the position taken by…

Author(s): Agnes V Klein, MD, DPH, Jian Wang, MD, PhD, Patrick Bedford, BSc, MA

biosimilar, Canada, reference biological product, subsequent entry biologics (SEBs)

DOI: 10.5639/gabij.2014.0303.033

Author byline as per print journal: Shon Crampton1, BA; Alla Polozova1, PhD; Darin Asbury2, BS; Alexis Lueras2, BS; Paul Breslin1, BS; Jane Hippenmeyer3, PharmD; Jennifer Litowski1, PhD; Monica Goss2, PhD Study objectives: To investigate the quality and in-use stability of diluted ABP 980 (a trastuzumab biosimilar) versus reference trastuzumab to mimic dosing in intravenous (IV)…

ABP 980, biosimilar, stability, trastuzumab

DOI: 10.5639/gabij.2020.0901.002

Introduction: The Association of Southeast Asian Nations (ASEAN) Overview Workshop on GMP for Biologicals and Biosimilars was co-organized with the Generics and Biosimilars Initiative (GaBI). This meeting was intended to improve the understanding of the good manufacture practice (GMP) inspection framework for biological (and biosimilar) drugs among ASEAN countries. Methods: The workshop was held on…

Author(s): Adjunct Associate Professor Sia Chong Hock, BSc (Pharm), MSc, Elwyn Griffiths, DSc, PhD

ASEAN, biologicals, biosimilars, GMP

DOI: 10.5639/gabij.2019.0803.015

Submitted: 24 January 2014; Revised: 29 January 2014; Accepted: 30 January 2014; Published online first: 12 February 2014 To the Editor: I read with interest the letter of Dr Edward T Maggio which was published in Volume 2/Year 2013/Issue 4 of the Generics and Biosimilars Initiative Journal [1] on the naming issue for biosimilars and…

Author(s): Professor Paul J Declerck, PhD

DOI: 10.5639/gabij.2014.0301.003

Editor's Letter

Published on 18 March 2014

Editor’s introduction to the initial issue of the third volume of GaBI Journal

This issue of the GaBI Journal begins with editorial comments from our Deputy Editor-in-Chief Dr Robin Thorpe concerning the Review Article by Azevedo et al. covering biosimilar regulations and their implementation in some Latin American countries. Three Original Research papers describe real life clinical examples relating to the use and evaluation of follow-on products respectively;…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2014.0301.001

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