Author byline as per print journal: Professor Philip D Walson, MD, Professor Stefan Mühlebach, PhD, Beat Flühmann, PhD Introduction: In recent years a new category of medicinal products, the non-biological complex drugs (NBCDs) emerged. They are distinct from both the small molecules and the biological therapeutics by being composed of non-homomolecular large structures, some of…

Author(s): Beat Flühmann, PhD, Professor Philip D Walson, MD, Professor Stefan Mühlebach, PhD

follow-on drugs, nanomedicines, non-biological complex drug (NBCD), regulatory practice

DOI: 10.5639/gabij.2014.0301.010

Abstract: In this paper, we provide an overview of a PhD project we undertook on European policy on generic medicines. In the course of our research, we identified various causes for delayed market access of generic medicines and the need for policies to accelerate market access. These should work in conjunction with policies designed to…

Author(s): Pieter Dylst, PharmD, Professor Arnold G Vulto, PharmD, PhD, FCP, Steven Simoens, MSc, PhD

demand-side policies, Europe, European policy, generic medicines, supply-side policies

DOI: 10.5639/gabij.2014.0301.011

Abstract: The pharmacist is an important patient advocate in the transplant multidisciplinary team and can support patients in their medication taking to improve medication adherence. Medicine optimization and patient information are also vital to this aim. For more than 20 years patients transplanted at our institution have undergone a structured post-operative self-medication training programme so…

Author(s): Andrea Devaney

generics substitution, immunosuoppressives, self-medication, tacrolimus, transplantation

DOI: 10.5639/gabij.2014.0302.023

Submitted: 31 October 2013; Revised: 6 November 2013; Accepted: 11 November 2013; Published online first: 25 November 2013 To the Editor: I wanted to bring to your attention the following paper which was published in Volume 2/Year 2013/Issue 3 of the Generics and Biosimilars Initiative Journal. The Perspective paper titled Licensing and prescribing biosimilars in…

Author(s): Brendan Shaw, PhD

DOI: 10.5639/gabij.2013.0204.048

Abstract: Legislation in support of pharmacist notification to patients and providers of substitution of an interchangeable biologic for the originator biologic was recently vetoed in California. Automatic substitution of approved biosimilars without notifying the patient and physician/healthcare provider circumvents important pharmacovigilance. Submitted: 21 October 2013; Revised: 22 October 2013; Accepted: 25 October 2013; Published online…

Author(s): Janet S Wyatt, RN, PhD, FAANP

biologicals, patients, REMS

DOI: 10.5639/gabij.2013.0204.045

Abstract: The Editor-in-Chief expresses his concerns about the proposal of a WHO run system to approve copy biologicals in the Milani and Gaspani paper [1]. The paper by Milani and Gaspani [1] suggests that the World Health Organization (WHO) sets up a programme to approve follow-on pegylated interferons and similar biological medications, that is biological…

Author(s): Professor Philip D Walson, MD

biological products, pegylated interferons, World Health Organization (WHO)

DOI: 10.5639/gabij.2013.0204.043

Abstract: As the patents of a growing number of biological medicines have already expired or are due to expire, it has led to an increased interest from both the biopharmaceutical industry and the regulatory agencies in the development and approval of biosimilars. With the high urgency, European Medicines Agency released the first general guideline on…

Author(s): Eric Chi, PhD, Nan Zhang, PhD

biosimilar, biosimilarity index, equivalence margin, follow-on biologics, interchangeability

DOI: 10.5639/gabij.2014.0301.007

Author byline as per print journal: Professor Stefan Mühlebach, PhD, Professor Arnold Vulto, PharmD, PhD, Jon SB de Vlieger, PhD, Vera Weinstein, PhD, Beat Flühmann, PhD, Vinod P Shah, PhD Introduction: Besides biologicals, a new class of complex drugs – non-biological complex drugs (NBCDs), e.g. liposomes, iron carbohydrate products and glatiramoids – has emerged. Originator…

Author(s): Beat Flühmann, PhD, Jon SB de Vlieger, PhD, Professor Arnold G Vulto, PharmD, PhD, FCP, Professor Stefan Mühlebach, PhD, Vera Weinstein, PhD, Vinod P Shah, PhD

glatiramoids, iron sucrose, liposomes, nanomedicines, non-biological complex drug (NBCD), similars

DOI: 10.5639/gabij.2013.0204.054

Abstract: Biological product quality is susceptible to unexpected manufacturing issues, and the resulting variation may impact the safety or efficacy of these medicines and increase risks to patients. These risks can be managed more effectively by manufacturers’ adoption of the culture and practices of high reliability organizations and by their sharing of quality risk management…

Author(s): Gustavo Grampp, PhD, Sundar Ramanan, PhD

biologicals, manufacturing, quality, safety

DOI: 10.5639/gabij.2013.0204.049

Abstract: This paper provides a detailed comparison of biosimilars guidelines issued in Canada, the European Union, Japan and Korea; and by the World Health Organization (WHO). This comparison highlights the need for harmonization of global regulatory standards for the approval of biosimilars. Biosimilars are recognized around the world as safe and effective medicines. Despite this…

Author(s): GaBI Journal Editor

biosimilars, Canada, EU, guidelines, Japan, Korea, regulation, World Health Organization (WHO)

DOI: 10.5639/gabij.2014.0401.012

Author byline as per print journal: Barbara Milan, Sara Gaspani Introduction: The current pipeline of promising oral hepatitis C drugs could lead to a revolution in treatment for this disease in both developed and developing countries. At present, the recommended treatment is pegylated interferon alpha (in combination with ribavirin). However, the limited availability and high…

Author(s): Barbara Milani, Sara Gaspani

biosimilars, competition, drug regulation, hepatitis C, pegylated interferon alpha, prices

DOI: 10.5639/gabij.2013.0204.053

Editor's Letter

Published on 30 September 2013

Latest features in GaBI Journal, 2013, Issue 3

The GaBI Journal again contains manuscripts covering a wide range of pertinent topics. In an Editorial, Dr Gianluigi Casadei reviews Italy’s final position paper on biosimilars including the new price and reimbursement position from the Italian Medicines Agency (Agenzia Italiana del Farmaco, AIFA). Dr Casadei questions how much of a ‘step forward’ as well as…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2013.0203.032