Epilepsy features the unpredictable onset of seizures that can be devastating to a patient’s quality of life. Fortunately there are medications available to control the onset of seizures. But because these have to be taken over the long term, healthcare providers need to consider whether to take advantage of cheap generic alternatives to brand-name antiepileptic…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2013.0201.002

Abstract: The clinical importance of biopharmaceuticals for the management of life threatening diseases is increasing but costs have become a major obstacle to the administration of these medicines, especially in resource limited healthcare systems. Introduction of biosimilars as a cost-effective alternative to innovator biopharmaceuticals has attracted the attention of both industry and policymakers. However, due…

Author(s): Professor Abdol Majid Cheraghali, PharmaD, PhD

biopharmaceuticals, biosimilars, Iran, pharmacovigilance

DOI: 10.5639/gabij.2013.0201.008

Author byline as per print journal: Richard O Dolinar, MD; Michael S Reilly Abstract  Biologicals are advanced prescription drugs to treat cancer, rheumatoid arthritis HIV/AIDS, multiple sclerosis and other debilitating diseases. In November 2010, the US Food and Drug Administration (FDA) began consultation with patient groups, physicians and industry on how to approve the first copies…

Author(s): Michael S Reilly, Esq, Richard O Dolinar, MD

biologicals, biosimilars, FDA guidelines, patient safety, pharmacovigilance

DOI: 10.5639/gabij.2013.0201.014

Editor's Letter

Published on 14 November 2012

Latest features in GaBI Journal, 2012, issue 3-4

This issue of the GaBI Journal uses a number of article formats to cover a range of issues related to generics and biosimilars. In Letters to the Editor, Dr Carlo Petrini presents and defends the suggestion that the clinical use of biosimilars poses ethical concerns that differ from those of other pharmaceutical products. He even…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2012.0103-4.037

Many healthcare professionals remain concerned about the safety and efficacy of biosimilars, and are hence reluctant to prescribe them for patients, despite the publication of guidelines for their approval by European regulatory authorities. This level of distrust may reflect a lack of engagement by the regulatory authorities with the medical community during the development of…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2012.0103-4.039

A recent study by IMS Health Austria (IMS) revealed that in Austria healthcare payers could have saved more than a quarter billion Euros during 2011 if physicians would have prescribed more generics to their patients. The total reimbursed medicines market in Austria totals Euros 1.89 billion. IMS estimates that 89% of the total market by…

Author(s): Christoph Baumgärtel, MD, MSc

DOI: 10.5639/gabij.2012.0103-4.038

Abstract:  Comment on the Letters to the Editor by Dr Carlo Petrini: A bioethicist’s view of the use of biosimilars, published in GaBI Journal, 2012, issue 3-4. Submitted: 9 November 2012; Revised: 12 November 2012; Accepted: 15 November 2012; Published online first: 19 November 2012 In GaBI Journal, 2012, issue 3-4, Dr Carlo Petrini [1] from the Italian National Institute of Health…

Author(s): Christian K Schneider, MD

DOI: 10.5639/gabij.2013.0201.001

Abstract: The Pharmaceuticals and Medical Devices Agency (PMDA) is Japan’s regulatory agency, which works together with the Ministry of Health, Labour and Welfare. At the 24th Drug Information Association Annual EuroMeeting in March 2012, PMDA presented an overview of recent trends and special topics in new drug review. Here, the current status and trends are…

Author(s): Toshiki Sugita, PhD

approval review, global clinical trials, Japanese regulatory authority, PMDA, prior assessment consultation

DOI: 10.5639/gabij.2013.0202.024

Submitted: 9 January 2013; Revised: 11 January 2013; Accepted: 15 January 2013; Published online first: 22 January 2013 In October 2012, the International Alliance of Patients’ Organizations (IAPO) launched its final Patient-Centred Healthcare Indicators Review and accompanying consultation report [1]. The review forms the initial stage of a wider project being undertaken by IAPO to develop a set of process and outcome…

Author(s): Yasemin Dil

DOI: 10.5639/gabij.2013.0201.005

Author byline as per print journal: Professor Shein-Chung Chow, PhD, Christine Ju, MSc Abstract: Biological (large molecule) drug products are made via living systems and are complex and variable in nature. As a result, generic forms of biological products, also termed biosimilars in the EU or follow-on biologics by the US Food and Drug Administration, can…

bioequivalence, biosimilarity, BPCIA, follow-on biologics, interchangeability

DOI: 10.5639/gabij.2013.0201.004

Abstract:  Biosimilars have the potential for making savings in healthcare costs, and with resource allocation, if competition is permitted at the level of treatment induction. Submitted: 24 August 2012; Revised: 17 January 2013; Accepted: 4 February 2013; Published online first: 13 February 2013 The last decade or so has seen the introduction of many truly innovative biological pharmaceuticals that have had a…

Author(s): Gustaf Befrits

biosimilar pharmaceuticals, biosimilars, EU, healthcare financing, substitution, Sweden

DOI: 10.5639/gabij.2013.0201.009

Author byline as per print journal: Professor Joan Rovira, PhD; Leandro Lindner, BSc; Emmanuel Giménez, BSc; Professor Jaime Espín, PhD; Antonio Olry de Labry, PhD; Leticia García, BSc Introduction and study objectives: To describe the development of biosimilars in 24 European Union (EU) Member States, plus Norway and Switzerland, and to identify the key parameters…

Author(s): Antonio Olry de Labry, PhD, Emmanuel Giménez, BSc, Leandro Lindner, BSc, Leticia García, BSc, Professor Jaime Espín, PhD, Professor Joan Rovira, PhD

biosimilars, European Union, market dynamics

DOI: 10.5639/gabij.2013.0201.012