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

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: 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

Abstract: The attractiveness of the biosimilar regulatory pathway is threatened by so-called biobetters. This paper provides definitions and an overview of recent developments. Submitted: 27 October 2014; Revised: 7 November 2014; Accepted: 12 November 2014; Published online first: 25 November 2014 Concerning the biosimilar landscape, the European Medicines Agency (EMA) was among the first institutions…

Author(s): René Anour, DVM

biobetter, biosimilar, competition, interchangeability, regulatory pathways

DOI: 10.5639/gabij.2014.0304.039

Abstract: Dr Brian Godman reviews the paper by Vogler and co-authors on the procurement of generics or originators among European hospitals once multiple sources become available. Submitted: 28 November 2014; Revised: 3 December 2014; Accepted: 3 December 2014; Published online first: 16 December 2014 Vogler and co-authors have provided valuable insight into the procurement of…

Author(s): Brian Godman, BSc, PhD

Europe, generics, hospitals, procurement

DOI: 10.5639/gabij.2014.0304.037

Editor's Letter

Published on 17 December 2014

Fourth and final issue of GaBI Journal’s third volume

The interest in the development, regulatory approval, use, and post-marketing surveillance of generic and biosimilar pharmaceutical products continues to increase; as illustrated by the tremendous number of views (over 1,028,324 since 2012) of articles published in the GaBI Journal. I expect that this interest will continue to increase after publication of this fourth and final…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2014.0304.036

Abstract: Representatives from Amgen and Actavis have spoken to GaBI (Generics and Biosimilars Initiative) about biosimilars. Topics covered included the clinical development of biosimilars, the need for further education, how the partnership model between the companies was working, the commercialization of biosimilars and their views on non-proprietary names for biosimilars Biotech giant Amgen and generics…

Author(s): GaBI Journal Editor

biosimilar, clinical development, commercializaiton, INN

DOI: 10.5639/gabij.2014.0303.035

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