Articles

Pharma News

Published on 07 February 2013

‘Similar biologics’ approved and marketed in India

There have been established guidelines for approving generic versions of small molecule chemical drugs in India for some time already. However, no specific guidelines for ‘similar biologics’, as the Indian...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2013.0201.006

13.207 views

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Perspective

Published on 11 January 2013

Biosimilarity in Latin America

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...

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

20.710 views

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Original Research

Published on 11 January 2013

The generic pharmaceutical industry: moving beyond incremental innovation towards re-innovation

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....

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

198.046 views

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Letters to the Editor

Published on 11 December 2012

Austria increases dialogue in order to involve physicians more with biosimilars

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...

Author(s): Christoph Baumgärtel, MD, MSc

DOI: 10.5639/gabij.2013.0201.003

12.945 views

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Abstracted Scientific Content

Published on 29 November 2012

Alleviating concerns around generic antiepileptic medications

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...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2013.0201.002

14.150 views

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Review Article

Published on 22 November 2012

Current status of biopharmaceuticals in Iran’s pharmaceutical market

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...

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

biopharmaceuticals, biosimilars, Iran, pharmacovigilance

DOI: 10.5639/gabij.2013.0201.008

25.939 views

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Perspective

Published on 22 November 2012

The future of biological therapy: a pathway forward for biosimilars

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....

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

biologicals, biosimilars, FDA guidelines, patient safety, pharmacovigilance

DOI: 10.5639/gabij.2013.0201.014

23.010 views

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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...

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2012.0103-4.037

10.589 views

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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

7.364 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

8.645 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

15.690 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, Japan’s regulatory agency, PMDA, prior assessment consultation

DOI: 10.5639/gabij.2013.0202.024

25.937 views

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