Articles

Editorial

Published on 13 March 2013

Health authority perspective on biosimilars

Abstract: Dr Brian Godman reviews Mr Gustaf Befrits’ paper on the case for biosimilars from a payer’s perspective. Biosimilars are increasingly important to payers with growing resource pressures. However, key...

Author(s): Brian Godman, BSc, PhD

biosimilars, economics

DOI: 10.5639/gabij.2013.0201.010

9.962 views

Read more →

Original Research

Published on 06 March 2013

How do regional sickness funds encourage more rational use of medicines, including the increase of generic uptake? A case study from Austria

Objective: To analyse similarities and differences between activities carried out by Austrian sickness funds to encourage more rational use of medicines, including increasing generics uptake. Methods: Semi-structured interviews with pharmacoeconomic...

Author(s): Sabine Vogler, PhD, Nina Zimmermann, MA

generics, generics uptake, medicines, monitoring, prescribing, rational use of medicines, sickness funds

DOI: 10.5639/gabij.2013.0202.027

42.453 views

Read more →

Perspective

Published on 06 March 2013

Equivalence of generic medicines in general and immunosuppressants in particular – a regulatory opinion on switching of ciclosporin, tacrolimus and mycophenolate mofetil

Abstract: This position paper deals with our regulatory opinion on registered generic immunosuppressants such as ciclosporin, tacrolimus and mycophenolate mofetil, and provides arguments why these medicines are considered equally safe...

Author(s): Marc Maliepaard, PhD, Yang Yu, PharmD, Professor Hubert GM Leufkens, PharmD, PhD

bioequivalence, drug safety, generics, immunosuppression, regulation

DOI: 10.5639/gabij.2013.0202.019

24.599 views

Read more →

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

13.275 views

Read more →

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

20.799 views

Read more →

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

198.418 views

Read more →

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

12.996 views

Read more →

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

14.178 views

Read more →

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

26.125 views

Read more →

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

23.077 views

Read more →

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

10.613 views

Read more →