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

Abstract: Biosimilar products confront novel market authorization and post-marketing use hurdles. Existing evidence is insufficient to fully address physician and payer acceptability thresholds. Submitted: 4 March 2015; Revised: 5 March 2015; Accepted: 9 March 2015; Published online first: 20 March 2015 In this issue of GaBI Journal, Sandorff et al. [1] investigate payer and physician…

Author(s): Professor Alan Lyles, BSPharm, MPH, ScD, PhD (h.c.)

acceptability, biologicals, biosimilars, interchangeability, pricing

DOI: 10.5639/gabij.2015.0401.002

Editor's Letter

Published on 26 March 2015

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

This first 2015 GaBI Journal issue (fourth volume of the journal) is being published soon after the first US biosimilar approval and it contains a number of articles that illustrate how the development, marketing and acceptance of biosimilars differ globally including in North and South America and the Persian Gulf States. An Editorial entitled Biosimilars:…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2015.0401.001

This was a joint meeting of the American Society of Transplant Surgeons (ASTS), The Transplant Society (TTS) and the American Society of Transplantation (ATS). The Congress was packed with an impressive number of interesting Symposia, State-of-the-Art Lectures as well as Plenary and Poster Sessions covering all aspects of basic and clinical research and care of…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2014.0304.047

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: Biotech giant Amgen now has a biosimilars programme that includes nine different molecules. A representative from Amgen has spoken to GaBI about the company’s venture into biosimilars. Topics included how to encourage the use of biosimilars and how a Japanese example of biosimilars uptake can help Europe in increasing use of biosimilars. Submitted: 25…

Author(s): GaBI Journal Editor

biosimilar, naming, uptake

DOI: 10.5639/gabij.2014.0304.048

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

Abstract: Australia currently has a small generic and biosimilar medicine industry despite having a good track record in biomedical research and a sound reputation in producing high quality but small volume biological pharmaceuticals. In recent times, Australia has made incremental changes to its regulation of biosimilars – in patent registration, in the use of commercial…

Author(s): David Lim, DPH

Australia, biosimilars, confidential information, patent, regulation, remuneration

DOI: 10.5639/gabij.2014.0304.042

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: 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

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

The world market for medicinal products is expected to reach US$1 trillion in 2014. Global spending on medicines is expected to grow to nearly US$1.2 trillion by 2017 [1]. As governments around the world try to rein in healthcare expenses, generics and biosimilars can play a major role in reducing this budgetary burden. Intellectual property…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2014.0304.046