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, there is no national level policy to enhance or promote generic medicines use. In addition, other challenges to the use of generic medicines in Yemen…

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

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 issues need addressing to fully capture their benefits. Submitted: 17 January 2013; Revised: 4 February 2013; Accepted: 8 February 2013; Published online first: 11 March 2013 Gustaf Befrits has provided us with…

Author(s): Brian Godman, BSc, PhD

biosimilars, economics

DOI: 10.5639/gabij.2013.0201.010

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 unit staff of four regional sickness funds in Austria. Results: Sickness funds include a variety of activities. The main target group is prescribers, who are…

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

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 and effective as the branded drug based on demonstrated bioequivalence. Though regulators acknowledge the worries from the field, we are of the opinion that there…

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

Author byline as per print journal: Robin Thorpe, PhD, FRCPath; Meenu Wadhwa, PhD Abstract: The importance of monoclonal antibodies as a product class and the challenge of assessing unwanted immunogenicity for these products have prompted the drafting of a new CHMP (Committee for Medicinal Products for Human Use) guideline. The ‘Guideline on immunogenicity assessment of…

Author(s): Meenu Wadhwa, PhD, Robin Thorpe, PhD, FRCPath

biosimilar, comparability, quality, risk, safety

DOI: 10.5639/gabij.2013.0201.007

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 regulatory authorities call these products, have existed in India until recently. This has been the case despite the fact that the requirements for granting regulatory…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2013.0201.006

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