Articles

Commentary

Published on 24 April 2013

Commentary on the recommendations of the European Society for Organ Transplantation Advisory Committee on generic substitution of immunosuppressive drugs

Abstract: In 2010, the Council of the European Society for Organ Transplantation formed an Advisory Committee to formulate recommendations on the use of generic drugs in solid organ transplant recipients....

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

ciclosporin, generics substitution, immunosuppression, mycophenolate, tacrolimus, transplantation

DOI: 10.5639/gabij.2013.0203.031

23.563 views

Read more →

Editorial

Published on 05 August 2013

Italy’s final position paper on biosimilars and new price and reimbursement pathway

Abstract: The AIFA’s position paper recognizes the relevance of biosimilars to ensure the sustainability of drug expenditure but the new price and reimbursement procedure may not favour their prompt market...

Author(s): Gianluigi Casadei, MD

AIFA, biosimilars, market access, position paper, pricing, reimbursement

DOI: 10.5639/gabij.2013.0203.033

16.572 views

Read more →

Editor's Letter

Published on 30 September 2013

Latest features in GaBI Journal, 2013, Issue 3

The GaBI Journal again contains manuscripts covering a wide range of pertinent topics. In an Editorial, Dr Gianluigi Casadei reviews Italy’s final position paper on biosimilars including the new price...

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2013.0203.032

4.384 views

Read more →

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

25.936 views

Read more →

Guidelines

Published on 06 May 2013

Update on clinical practice guideline on the use of epoetin and darbepoetin in adult patients with cancer

Abstract: Chemotherapy-induced anaemia can be treated using erythropoiesis-stimulating agents (ESAs), but these can cause serious side-effects including tumour progression, venous thromboembolism, and shorter survival. Following extensive review of recent literature,...

Author(s): GaBI Journal Editor

chemotherapy-induced anaemia, darbopoetin, epoetin, erythropoetin-stimulating agents, haemoglobin, thromboembolism

DOI: 10.5639/gabij.2013.0202.018

6.638 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

20.709 views

Read more →

Perspective

Published on 02 July 2012

Biosimilars in oncology: current and future perspectives

Abstract: Cancer represents a significant, and growing, burden on healthcare systems. This is driven, at least in part, by escalating cancer drug budgets. Loss of patent protection on biopharmaceuticals enables...

Author(s): Matti Aapro, MD

biosimilars, cost burden, oncology

DOI: 10.5639/gabij.2013.0202.023

27.518 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, generic, immunosuppression, regulation

DOI: 10.5639/gabij.2013.0202.019

24.545 views

Read more →

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

22.455 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

42.362 views

Read more →

Letters to the Editor

Published on 18 April 2013

Challenges to generic medicines utilization in Yemeni healthcare system

Abstract: Generic medicines are promoted in many countries as an essential part of the healthcare system. However, in Yemen, there are many challenges to the utilisation of generic medicines. Currently,...

Author(s): Saleh Karamah AL-Tamimi, BPharm, MPharm (ClinPharm), Mohamed Azmi Ahmad Hassali, PhD, Alian A Alrasheedy, BPharm(Hons), MPharm(Clin), BCPS

challenges, consumers, generic medicines, healthcare professionals, Yemen

DOI: 10.5639/gabij.2013.0202.017

13.606 views

Read more →