Articles

Perspective

Published on 14 December 2016

Pharmacovigilance of biosimilars and other biologicals within the hospital: current practices and future challenges

Author byline as per print journal: Barbara OM Claus, PharmD, PhD; Tiene Bauters, PharmD, PhD; Annemie Somers, PharmD, PhD Abstract: In the coming decade, many patents for biological pharmaceuticals will expire....

Author(s): Barbara OM Claus, PharmD, PhD, Professor Annemie Somers, PharmD, PhD, Tiene Bauters, PharmD, PhD

biologicals, biosimilars, hospitals, pharmacovigilance

DOI: 10.5639/gabij.2017.0601.005

8.160 views

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Review Article

Published on 23 January 2017

Ocular emulsions and dry eye: a case study of a non-biological complex drug product delivered to a complex organ to treat a complex disease

Author byline as per print journal: Anu Gore, PhD; Mayssa Attar, PhD; Chetan Pujara, PhD; Sesha Neervannan, PhD Abstract: Generic drugs are intended to provide a lower cost option of safe...

Author(s): Anu Gore, PhD, Chetan Pujara, PhD, Mayssa Attar, PhD, Sesha Neervannan, PhD

dry eye, ocular, ophthalmic, safety, topical

DOI: 10.5639/gabij.2017.0601.004

18.031 views

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Original Research

Published on 14 December 2016

Naming and labelling of biologicals – a survey of US physicians’ perspectives

Introduction: The US Food and Drug Association (FDA) released its requirements for the non-proprietary naming of biological products in January 2017. Before the FDA’s release, the Alliance for Safe Biologic...

Author(s): Harry L Gewanter, MD, FAAP, FACR, Michael S Reilly, Esq

ASBM, biosimilar, interchangeability, labelling, legislation, naming

DOI: 10.5639/gabij.2017.0601.003

10.433 views

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Letters to the Editor

Published on 26 October 2016

Pricing strategies for pharmaceuticals in developing countries: what options do we have?

Abstract: Effective pharmaceutical pricing policies in developing countries are important to ensure accessibility and affordability of essential medicines for the people. Submitted: 24 October 2016; Revised: 27 February 2017; Accepted:...

Author(s): Nada Moustafa Abdel Rida, MSc Candidate, Professor Mohamed Izham Mohamed Ibrahim, PhD

developing countries, external reference pricing, government strategies, medicines, pharmaceutical pricing policy, price containment

DOI: 10.5639/gabij.2017.0601.002

9.594 views

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Editor's Letter

Published on 08 March 2017

Editor’s introduction to the initial issue of the sixth volume of GaBI Journal

This first issue of 2017 includes a range of manuscripts of interest to readers. A Letter to the Editor from Professor Mohamed Izham Mohamed Ibrahim and Nada Moustafa Abdel Rida...

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2017.0601.001

3.160 views

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Abstracted Scientific Content

Published on 12 December 2016

Strategies used to delay or prevent access to affordable generic drugs in the US

Submitted: 28 November 2016; Revised: 29 November 2016; Accepted: 30 November 2016; Published online first: 5 December 2016 In the journal Blood, Jones et al. [1] discuss strategies used by...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2016.0504.051

5.024 views

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Abstracted Scientific Content

Published on 14 December 2016

An empirical study of market-based purchasing policies for generic pharmaceuticals in Sweden

Submitted: 1 December 2016; Revised: 6 December 2016; Accepted: 7 December 2016; Published online first: 12 December 2016 In Sweden, the government funds an insurance programme covering 75–80% of the...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2016.0504.050

4.104 views

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Abstracted Scientific Content

Published on 31 October 2016

Essential information for internists on biologicals and biosimilars

Submitted: 21 November 2016; Revised: 22 November 2016; Accepted: 24 November 2016; Published online first: 30 November 2016 Authors from the IRCCS – Istituto di Ricerche Farmacologiche ‘Mario Negri’, Milan,...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2016.0504.049

4.123 views

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Abstracted Scientific Content

Published on 31 October 2016

Effect of naming on pharmacists’ perceptions and dispensing of biosimilars

Submitted: 21 November 2016; Revised: 22 November 2016; Accepted: 24 November 2016; Published online first: 30 November 2016 A study of pharmacists investigated their perceptions of biosimilar naming conventions and...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2016.0504.048

6.967 views

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Meeting Report

Published on 16 December 2016

Data requirements to demonstrate biosimilarity in the EU

Abstract: How has the European Medicines Agency (EMA) changed its requirements for biosimilars since it first approved biosimilars in 2006? This is the question Dr Martina Weise, Head of Licensing...

Author(s): GaBI Journal Editor

biosimilar, biosimiliarity, data requirements, extrapolation

DOI: 10.5639/gabij.2016.0504.047

6.726 views

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Special Report

Published on 26 March 2015

Generic medicines entry into the Malaysian pharmaceutical market

Author byline as per print journal: Omotayo Fatokun, PhD; Professor Mohamed Izham Mohamed Ibrahim, PhD; Professor Mohamed Azmi Hassali, PhD Abstract: There are major barriers to generic medicine development and market...

Author(s): Omotayo Fatokun, PhD, Professor Mohamed Azmi Hassali, PhD, Professor Mohamed Izham Mohamed Ibrahim, PhD

generic medicines, Malaysia, market entry, patent, pharmaceutical market

DOI: 10.5639/gabij.2016.0504.046

12.111 views

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Special Report

Published on 12 December 2016

The role of European Pharmacopoeia monographs in setting quality standards for biotherapeutic products

Abstract: European Pharmacopoeia (Ph. Eur.) monographs for biotherapeutic products have existed since the 1990s and remain the publicly available standard defining the quality of these medicines. Continued development of such...

Author(s): Emmanuelle Charton, PhD

biotherapeutic products, complexity of biologicals, monographs, pharmacopoeia, public standards

DOI: 10.5639/gabij.2016.0504.045

20.510 views

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