Articles

Abstracted Scientific Content

Published on 14 November 2012

The potential for doctors to contribute to biosimilar guidelines

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...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2012.0103-4.039

7.397 views

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Published on 14 November 2012

Austria could save Euros 256 million by using more generics

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...

Author(s): Christoph Baumgärtel, MD, MSc

DOI: 10.5639/gabij.2012.0103-4.038

8.675 views

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Letters to the Editor

Published on 12 November 2012

The ethics of biosimilars

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...

Author(s): Christian K Schneider, MD

DOI: 10.5639/gabij.2013.0201.001

15.740 views

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Conference Report

Published on 12 November 2012

Recent trends and special topics in new drug review in PMDA

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...

Author(s): Toshiki Sugita, PhD

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

DOI: 10.5639/gabij.2013.0202.024

26.000 views

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For Patients

Published on 19 October 2012

IAPO launched the Patient-Centred Healthcare Indicators Review

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...

Author(s): Yasemin Dil

DOI: 10.5639/gabij.2013.0201.005

7.502 views

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Review Article

Published on 19 October 2012

Assessing biosimilarity and interchangeability of biosimilar products under the Biologics Price Competition and Innovation Act

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....

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

DOI: 10.5639/gabij.2013.0201.004

37.437 views

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Commentary

Published on 11 October 2012

The case for biosimilars–a payer’s perspective

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...

Author(s): Gustaf Befrits

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

DOI: 10.5639/gabij.2013.0201.009

13.034 views

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Review Article

Published on 11 October 2012

Biosimilars in the European market

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...

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

26.671 views

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Perspective

Published on 11 October 2012

Why bioequivalence and unconditional interchangeability of generic drugs are not the same

Abstract: The patents for a number of cornerstone immunosuppressive drugs used in the field of solid organ transplantation have expired. Generic formulations are now available and several professional societies and...

Author(s): Professor Teun van Gelder, MD, PhD

bioequivalence, generics substitution, immunosuppression, transplantation

DOI: 10.5639/gabij.2013.0202.020

22.501 views

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Letters to the Editor

Published on 11 October 2012

A clinician’s view of the ethics of the use of biosimilars

Abstract:  Comment on the Letters to the Editor by Dr Carlo Petrini: A bioethicist’s view of the use of biosimilars Submitted: 8 October 2012; Revised: 9 October 2012; Accepted: 9 October 2012;...

Author(s): Dr Kalle Hoppu

DOI: 10.5639/gabij.2012.0103-4.035

9.272 views

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Letters to the Editor

Published on 11 October 2012

A bioethicist’s view of the use of biosimilars

Abstract:  In recognition of the many ethically sensitive issues raised by the production and use of biosimilar medicinal products, the author imagines having to answer the non-multiple choice question ‘From...

Author(s): Carlo Petrini, PhD

bioethics, drugs, ethics committees, legislation, risk, safety

DOI: 10.5639/gabij.2012.0103-4.034

12.315 views

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