Abstract: This article explains what motivated the Digestive Cancers Europe’s (DiCE) recent position paper on biosimilar medicines for colorectal cancer. Submitted: 7 October 2019; Revised: 14 October 2019; Accepted: 15 October 2019; Published online first: 25 October 2019 Background Colorectal cancer may not be as widely known or talked about as some other types of…

Author(s): Zorana Maravic, BSc, MBA

biosimilars, colorectal cancer, digestive cancers, patients, position paper

DOI: 10.5639/gabij.2019.0803.017

Author byline as per print journal: Jon SB de Vlieger1, PhD; Professor Daan JA Crommelin2, PhD; Beat Flühmann3, PhD; Professor Imre Klebovich4, PharmD, PhD, DSc; Professor Stefan Mühlebach3,5, PhD; Vinod P Shah6, PhD Abstract: The 3rd International Symposium on Scientific and Regulatory Advances in Biological and Non-Biological Complex Drugs: A to Z in Bioequivalence (3rd…

Author(s): Beat Flühmann, PhD, Daan JA Crommelin, Imre Klebovich, Jon SB de Vlieger, PhD, Professor Stefan Mühlebach, PhD, Vinod P Shah, PhD

biological medicinal products, equivalence, nanomedicines, NBCD similar approach, non-biological complex drug (NBCD)

DOI: 10.5639/gabij.2019.0803.016

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

Author byline as per print journal: Eric CK Siu1,4, MSc, PhD; Anne Tomalin2,4, BA, BSc; Kevin West3,4, BA; Sandra Anderson4, BA, MBA; George Wyatt1,4, BSc, MBA Abstract: Since the introduction of the first infliximab biosimilar, Inflectra®, significant changes have taken place in the Canadian biosimilar landscape, and both the regulatory and the reimbursement processes have…

Author(s): Anne Tomalin, BA, BSc, Eric CK Siu, MSc, PhD, George Wyatt, BSc, MBA, Kevin West, BA, Sandra Anderson, BA, MBA

biosimilars, CADTH CDR, CADTH pCODR, Health Canada, INESSS, pCPA

DOI: 10.5639/gabij.2019.0803.014

Author byline as per print journal: Steven Kozlowski1, MD; Ellen Tworkoski2, MS, MPhil; Carmen Dekmezian2, MS; Yanchang Zhang2, MPH; Natasha Flowers2, BA; Alvin So3, MS; Andreas M Schick3, PhD; Michael Wernecke2, BA; Thomas MaCurdy2,4, PhD; Jeffrey A Kelman5, MD, MMSc Background: Drug pricing and availability are key concerns for reducing healthcare costs and meeting patient…

Author(s): Jeffrey A Kelman, MD, MMSc, Steven Kozlowski, MD, Ellen Tworkoski, MS, MPhil, Carmen Dekmezian, MS, Yanchang Zhang, MPH, Natasha Flowers, BA, Alvin So, MS, Andreas M Schick, PhD, Michael Wernecke, BA, Thomas MaCurdy, PhD

generic drugs, pharmacy, US Medicare

DOI: 10.5639/gabij.2019.0803.013

Author byline as per print journal: Brian Godman1,2,3, BSc, PhD; Eleonora Allocati4, BSc, MSc; Evelien Moorkens5, BSc, MSc Abstract: Siu et al. comprehensively assessed the rapidly changing regulation and reimbursement environment for biologicals and biosimilars in Canada and the resultant implications. The current situation in Canada is compared with similar initiatives across different countries to…

Author(s): Brian Godman, BSc, PhD, Eleonora Allocati, BSc, MSc, Evelien Moorkens, BSc, MSc

biologicals, biosimilars, Canada, policy, regulation, savings

DOI: 10.5639/gabij.2019.0803.012

Editor's Letter

Published on 25 November 2019

Latest features in GaBI Journal, 2019, Issue 3

Patients, their families and providers are facing increasing pressures related to the rapidly expanding global inequality which affects access to all components of a long, healthy, productive life including water, food, shelter, medical care, education, a free press, stable government and freedom from both natural and man-made threats including genocide and war. Attempts to increase…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2019.0803.011

Submitted: 29 January 2019; Revised: 4 February 2019; Accepted: 5 February 2019; Published online first: 14 February 2019 Generic prescription drug prices have been escalating rapidly in the US. In 2014 alone, generic drug prices increased by 38% on average. Public outcry has led to a flurry of recent legislative proposals, and two federal bills…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2019.0802.010

Introduction: The number of biosimilars, or similar biotherapeutic products, is expanding rapidly worldwide. A further 12 blockbuster biologicals are set to add to this number by 2020. Agreement about the best practices for the regulation, use, interchangeability and pharmacovigilance of biosimilars is lacking in many countries including in the Middle East and North Africa (MENA).Methods:…

Author(s): Andrea Laslop, MD, Jian Wang, MD, PhD, Robin Thorpe, PhD, FRCPath

biosimilars, costs, MENA (Middle East and North Africa), pharmacovigilance, regulators, switching

DOI: 10.5639/gabij.2019.0802.009

Author byline as per print journal: G Castañeda-Hernández, PhD; L Carbajal-Rodríguez, MD; M Cerón-Rodríguez, MD; Professor LC Correa-González, MD; A Esquivel-Aguilar, PhD; SJ Franco-Ornelas, MD; JE García Ortiz, PhD; CM Hernández-Guadarrama, MD; JI Navarrete-Martínez, MD; Y Santillán-Hernández, MD; E Terreros-Muñoz, MD Abstract: Enzyme replacement therapy (ERT) is the first-line treatment for Gaucher disease (GD). The…

Author(s): A Esquivel-Aguilar, PhD, CM Hernández-Guadarrama, MD, E Terreros-Muñoz, MD, G Castañeda-Hernández, JE García Ortiz, PhD, JI Navarrete-Martínez, MD, L Carbajal-Rodríguez, MD, M Cerón-Rodríguez, MD, Professor LC Correa-González, MD, SJ Franco-Ornelas, MD, Y Santillán-Hernández

biosimilar, Gaucher disease, imiglucerase, non-originator imiglucerase, orphan drugs

DOI: 10.5639/gabij.2019.0802.008

Author byline as per print journal: Brian Godman1,2,3,4, BSc, PhD; Andrew Hill5; Professor Steven Simoens6, MSc, PhD; Amanj Kurdi1,7, BSc, PhD; Jolanta Gulbinovič8, MD, PhD; Antony P Martin2,9; Angela Timoney1,10; Dzintars Gotham11, MBBS; Janet Wale12; Tomasz Bochenek13, MD, PhD; Celia C Rothe13; Iris Hoxha14; Admir Malaj15; Christian Hierländer16; Robert Sauermann16, MD; Wouter Hamelinck17; Zornitza Mitkova18;…

Author(s): Brian Godman, BSc, PhD, Steven Simoens, MSc, PhD

cancer, Europe, generic drug regulations, generics, health policies, pricing

DOI: 10.5639/gabij.2019.0802.007

Editor's Letter

Published on 14 August 2019

Unmet potential of Generics and Biosimilars to reduce healthcare costs

The high cost of pharmaceuticals has been gaining increasing attention as a threat to both healthcare systems and patients’ access to care globally. This GaBI issue contains articles focusing on the fact that generics and follow-on biologicals have yet to achieve their potential to mitigate these costs in most if not all countries. In an…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2019.0802.006