Abstract: The introduction of new legislation in Latin America for the approval of biosimilar products follows implementation of EU legislation in 2005 for biosimilars approval. The establishment of regulatory processes for these complex drugs will ensure that evidence of safety and efficacy is obtained before approval. Biosimilars are high on the health-policy agenda because they…

Author(s): Chang Chiann, PhD, Leonardo de Souza Teixeira, PhD, Fabiana Fernandes de Santana e Silva Cardoso, MSc, Isabela da Costa César, PhD, Gerson Antônio Pianetti, PhD

biosimilarity, complex drugs, Latin America

DOI: 10.5639/gabij.2013.0202.021

Background: Due to the declining innovativeness of the classic R & D model in the original pharmaceutical industry, the generic pharmaceutical industry is aiming to become an innovation generator itself. Objective: The objective of this article is to gain insight into the re-innovation model in some of the innovative generic pharmaceutical firms. To this effect,…

Author(s): Fereshteh Barei, PhD, Professor Claude Le Pen, PhD, Steven Simoens, MSc, PhD

competition strategy, product portfolio, re-innovation, super generics, technology platforms

DOI: 10.5639/gabij.2013.0201.011

Abstract: Comment on the GaBI Journal article titled The potential for doctors to contribute to biosimilar guidelines [1] and the GaBI Online article titled Dialogue needed to build confidence in biosimilars [2], both by GaBI Journal Editor, Dr Julie Clayton. Submitted: 18 November 2012; Revised: 3 December 2012; Accepted: 4 December 2012; Published online first:…

Author(s): Christoph Baumgärtel, MD, MSc

DOI: 10.5639/gabij.2013.0201.003

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