Contents Editor's Letter What to look forward to in GaBI Journal, 2013, Issue 2 Editorial National and regional activities by sickness funds in Austria to encourage the rational use of medicines Letters to the Editor Access to liposomal generic formulations: beyond AmBisome and Doxil/Caelyx Challenges to generic medicines utilization in Yemeni healthcare system Original Research…

Contents Editor's Letter Editor’s introduction to the wide range of topics in the initial issue of the second volume of GaBI Journal Letters to the Editor The ethics of biosimilars Austria increases dialogue in order to involve physicians more with biosimilars Editorial Health authority perspective on biosimilars Commentary The case for biosimilars–a payer’s perspective Original…

Contents Editor's Letter Latest features in GaBI Journal, 2012, issue 3-4 Letters to the Editor A bioethicist’s view of the use of biosimilars A clinician’s view of the ethics of the use of biosimilars Editorial Generics policies–a globally-relevant implementation challenge Reference price systems: stakeholder dialogue and involvement Commentary Statin generics: no differences in efficacy after…

Contents Editor's Letter What to look forward to in GaBI Journal, 2012, issue 2 Editorial Equal protection under the law: Children and the Best Pharmaceuticals for Children Act Regulatory Tighter EU rules on pharmacovigilance for biologicals Review Article What lessons can be learned from the launch of generic clopidogrel? Payers endorse generics to enhance prescribing…

Contents Editor's Letter Introduction to the GaBI Journal Editorial Generic medicine pricing: on track in Europe? Commentary Innovator companies should focus on innovations Review Article A review of generic medicine pricing in Europe Biologicals and biosimilars: a review of the science and its implications A patient-centred paradigm for the biosimilars market European payer initiatives to…

Abstract: The regulatory oversight of biologicals in Malaysia is established by the National Pharmaceutical Control Bureau (NPCB), Ministry of Health. At the agency, the Section on Biotechnology Product Registration exercises the marketing authorization function as the National Regulatory Authority (NRA). This paper provides an overview of the organization, regulatory expectations and current practices of the…

Author(s): Arpah Abas, BPharm, Yvonne Siew Khoon Khoo, BPharm (Hons) MMedSc, PhD (Pharmacology)

biologicals, evaluation, Malaysia, National Pharmaceutical Control Bureau (NPCB), regulation

DOI: 10.5639/gabij.2014.0304.044

Two countries that were affected by the recent economic recession in different ways, and amended their pharmaceutical policies very differently, have provided researchers with an invaluable data set pointing to the strengths and weaknesses of contrasting pharmaceutical sector policies. The use of antipsychotic medicines across Finland and Portugal following the recession has been analysed in…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2014.0304.049

Abstract: Clinical safety is important during the development of a biosimilar. This paper provides an overview of the main aspects related to the safety assessment of biosimilars. The European Medicines Agency’s ‘Guideline for similar biological medicinal products containing biotechnology-derived proteins as active substances: non-clinical and clinical issues’, which is currently under revision, forms the basis…

Author(s): Christian K Schneider, MD, Thijs J Giezen, PharmD, PhD, MSc

biosimilar, clinical safety, immunogenicity, pharmacovigilance

DOI: 10.5639/gabij.2014.0304.041

Editor's Letter

Published on 05 September 2014

Latest features in GaBI Journal, 2014, Issue 3

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.2014.0303.026

Abstract: The European Medicines Agency (EMA) has led the development of biosimilar regulatory pathways globally, tailoring their approach to meet the specific and scientifically determined needs of biosimilar development. However, the information-driven stepwise approach encouraged by this pathway leading to approval of biosimilar products is only reflected in a single section of the product labelling…

Author(s): European Biopharmaceutical Enterprises

biosimilars, EMA (European Medicines Agency), labels, PIL (product information leaflet), Summary of Product Characteristics (SmPC)

DOI: 10.5639/gabij.2014.0304.043

Abstract: Alternative biopharmaceuticals could substantially improve affordability of biotherapeutics in developing countries. However, it seems that these countries need a modified regulatory pathway to guarantee timely access to these medicines. Submitted: 27 August 2014; Revised: 14 September 2014; Accepted: 15 September 2014; Published online first: 29 September 2013 In recent years, biotherapeutics have gained a…

Author(s): Professor Abdol Majid Cheraghali, PharmaD, PhD

affordability, alternative biopharmaceuticals, regulation

DOI: 10.5639/gabij.2014.0304.038

Aim: To explore whether medicines used in hospitals in European countries are supplied as originators or generic medicines, and to investigate the procurement conditions, including the extent of discounts at which the medicines are provided. Methodology: In September 2009, we collected primary data for four commonly used medicines in 25 public hospitals in five medium-sized…

Author(s): Sabine Vogler, PhD, Nina Zimmermann, MA, Jan Mazag, PharmaDr

cardiovascular medicines, discounts, generics, procurement, rebates, tender

DOI: 10.5639/gabij.2014.0304.040