Author byline as per print journal: Professor Teun van Gelder, MD, PhD; Benedicte Lunddahl, DVM; Professor Barbara OM Claus, PharmD, PhD Abstract: The Medicines for Europe’s Biosimilar Medicines Group met at the 2017 European Association of Hospital Pharmacists conference in France to discuss pharmacovigilance, traceability and building trust in biosimilar medicines. Submitted: 22 May 2017; Revised: 21…

Author(s): Barbara OM Claus, PharmD, PhD, Benedicte Lunddahl, DVM, Professor Teun van Gelder, MD, PhD

biological, biosimilar, European Union, pharmacovigilance, regulatory, traceability

DOI: 10.5639/gabij.2017.0603.026

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

Submitted: 10 February 2015; Revised: 24 February 2015; Accepted: 25 February 2015; Published online first: 6 March 2015 The past year has once again been a busy one for the biosimilars industry. One of the most important milestones during 2014 was the news that the US Food and Drug Administration (FDA) had accepted several biosimilars…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2015.0401.010

Submitted: 30 January 2018; Revised: 8 February 2018; Accepted: 12 February 2018; Published online first: 26 February 2018 The past year has once again been a busy one for the biosimilars industry. Important milestones achieved during 2017 were the biosimilar approvals of Renflexis (infliximab-abda), Cyltezo (adalimumab-adbm), Mvasi (bevacizumab-awwb), Ixifi (infliximab-qbtx) and Ogivri (trastuzumab-dkst), along with…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2018.0701.008

Abstract:  This commentary discusses the need to develop methods to ensure the availability of non-profitable, off-patent medicines to children and other populations. The history and some of the shortcomings of legislative attempts to provide drug therapy to children are briefly reviewed. Some examples of the inability of the current generics and non-generics pharmaceutical industry as…

Author(s): Professor Philip D Walson, MD

off-patent drugs, orphan, paediatric

DOI: 10.5639/gabij.2012.0101.010

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

Author byline as per print journal: Rana Musa Ali Al-ali “Malkawi”, MSc; Wesal Salem Al Haqaish, BPharm; Hayel Obeidat, MD Abstract: The regulatory oversight of medicinal products in Jordan is the responsibility of the Jordan Food and Drug Administration (JFDA). In 2015, JFDA adopted biosimilar guidelines, which are similar to those used by the European…

Author(s): Hayel Obeidat, MD, Rana Musa Ali Al-ali “Malkawi”, MSc, Wesal Salem Al-haqaish, BPharm

biological, biosimilar, EMA, INN, Jordan FDA, regulation

DOI: 10.5639/gabij.2018.0702.016

Abstract: Biological and biotechnological medicines are important pharmaceutical innovations due to their influence on the treatment of many conditions and because they have led the way in devising new and innovative pharmacological therapies. In addition, biosimilars, which can be authorized on the date of expiry of a biological originator’s patent, give an opportunity for the…

Author(s): Enrico Adriano Raffaelli, LLB, JD, Fausto Massimino, LLB, JD

advertising, biosimilars, competition, Italy, public tenders, scientific information

DOI: 10.5639/gabij.2019.0801.002

Author byline as per print journal: Sandeep N Athalye1, MBBS, MD; Dev B Baruah1, MPharm; Shivani Mittra1, MPharm, PhD; Ankit Ranpura1, MD; Kuldeep Kumar1, PhD; Elena Wolff-Holz2, MD Abstract: Ethnic sensitivity assessments in the form of bridging pharmacokinetics (PK) studies are often needed for biosimilar monoclonal antibodies (mAbs) to meet regulatory requirements in regions like…

biosimilar development, ethnic sensitivity assessments, global access, monoclonal antibodies, multi-regional clinical trials, regulatory reforms

DOI: 10.5639/gabij.2023.1202.010

Author byline as per print journal: Brian Godman, BSc, PhD; Claudia Wild, PhD; Alan Haycox, PhD Abstract: Venkatesan S et al. have researched patent rights and pricing for (non-)tyrosine kinase inhibitors. It is not clear why the patent rights are so long and why prices of (non-)tyrosine kinase inhibitors can be high. These issues are discussed.…

Author(s): Alan Haycox, PhD, Brian Godman, BSc, PhD, Claudia Wild, PhD

cancer medicines, generics, health gain, prices, tyrosine kinase inhibitors (TKI)

DOI: 10.5639/gabij.2017.0603.021

Abstract: Notwithstanding the scientific and regulatory differences between generic and biosimilar medicines, the European Medicines Agency/Committee for Medicinal Products for Human Use has consistently applied a ‘same active substance’ approach to both. Submitted: 28 November 2014; Revised: 20 January 2015; Accepted: 27 January 2015; Published online first: 30 January 2015 It is often stated that…

Author(s): Barbara J van Zwieten-Boot, Marcel Hoefnagel, Peter MJM Jongen, R Martijn van der Plas

active substance, biosimilar, EMA, Europe, guidelines, regulatory

DOI: 10.5639/gabij.2015.0401.004

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