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

Abstract: Biosimilar monoclonal antibodies (mAbs) are making their way onto the drug market. Because these are complex molecules in terms of structure and function, assessing similarity between originator and biosimilar mAb is challenging. This review discusses the hallmarks of similarity testing between originator products and mAb biosimilars in terms of product quality attributes, non-clinical and…

Author(s): Vera Brinks, MSc, PhD

biosimilar monoclonal antibodies, immunogenicity, similarity assessment

DOI: 10.5639/gabij.2013.0204.052

Abstract: Despite the fact that US Food and Drug Administration has yet to receive a biosimilars application, many US states have been considering legislation which could potentially limit biosimilars substitution. The Biologics Price Competition and Innovation Act (BPCI Act) of 2009 was signed into law on 23 March 2010 by President Barack Obama. The BPCI…

Author(s): GaBI Journal Editor

biologicals, biosimilars substitution, state legislation

DOI: 10.5639/gabij.2013.0203.040

Abstract: The AIFA’s position paper recognizes the relevance of biosimilars to ensure the sustainability of drug expenditure but the new price and reimbursement procedure may not favour their prompt market access. Submitted: 26 June 2013; Revised: 10 July 2013; Accepted: 11 July 2013; Published online first: 24 July 2013 In the final position paper on…

Author(s): Gianluigi Casadei, MD

AIFA, biosimilars, market access, position paper, pricing, reimbursement

DOI: 10.5639/gabij.2013.0203.033

Editor's Letter

Published on 03 July 2013

What to look forward to in GaBI Journal, 2013, Issue 2

The first of two Letters to the Editor is from Ms Gaspani and Ms Milani expressing their concerns about the lack of clear regulatory guidelines for approval of liposomal generic formulations. Liposomal products are only one and perhaps some of the best-characterized example of non-biological complex drugs (NBCDs). NBCDs while not having a biological source…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2013.0202.028

Abstract: Dr Brian Godman reviews the paper by Vogler and Zimmermann on sickness fund activity in Austria to preferentially encourage the prescribing of generics. This is particularly important given the resources that can be released through increased prescribing of generics. Submitted: 10 June 2013; Revised: 11 June 2013; Accepted: 12 June 2013; Published online first: 20 June 2013 Vogler and Zimmermann have…

Author(s): Brian Godman, BSc, PhD

Austria, demand-side measures, generics, sickness funds

DOI: 10.5639/gabij.2013.0202.026

Abstract: Dr Brian Godman reviews the paper by Markovic-Pekovic et al. regarding recent reforms in the Republic of Srpska. These include prescribing restrictions where concerns with the value of products and measures to obtain low prices for generics, which is important given the rhetoric. Submitted: 11 June 2013; Revised: 13 June 2013; Accepted: 17 June…

Author(s): Brian Godman, BSc, PhD

demand-side measures, generics, renin-angiotensin inhibitor drugs, Srpska, statins, supply-side measures

DOI: 10.5639/gabij.2013.0203.029