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

Abstract: As a practicing endocrinologist and Chairman of the Alliance for Safe Biologic Medicines, I am writing to commend the World Health Organization for its attention to and upcoming action on the important issue of non-proprietary names for biotech medicines. Submitted: 20 September 2013; Revised: 21 September 2013; Accepted: 21 September 2013; Published online first:…

Author(s): Richard O Dolinar, MD

biological identification, INN, public safety, World Health Organization (WHO)

DOI: 10.5639/gabij.2013.0204.047

Author byline as per print journal: Andrew Mica, MBA, Martha Mutomba, PhD, Larry Green, PharmD Introduction: When drug shortages occur, healthcare providers (HCPs) often must ration drugs, cancel or delay treatments, or utilize alternative drugs that may be less efficacious and/or are associated with increased risk of adverse outcomes, potentially impacting patient care. The likelihood…

Author(s): Andrew Mica, MBA, et al.

biological, drug shortages, healthcare provider, manufacturing, supply chain

DOI: 10.5639/gabij.2013.0203.038

Abstract: With the advent of complex therapies in the form of biologicals, emerging biosimilars and non-biological complex drugs, monitoring for treatment related benefit and the potential for adverse effects is as critical as monitoring for signs and symptoms of rheumatoid arthritis disease progression. With a focus on strengthening patient and provider education and engagement, patients…

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

biological therapy, patient engagement, pharmacovigilance, treatment response

DOI: 10.5639/gabij.2014.0301.008