Articles

Editorial

Published on 12 June 2017

Trends and challenges in biosimilars pricing and reimbursement policies in Europe and beyond

Abstract: Biosimilars policies are more controversial than those for generics. However, it is only a question of time before progress in biosimilars matches that of generics worldwide. Submitted: 21 April...

Author(s): Alessandro Curto, MSSc

biosimilars, Europe, pricing, reimbursement

DOI: 10.5639/gabij.2017.0602.012

10.514 views

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Editor's Letter

Published on 12 June 2017

What to look forward to in GaBI Journal, 2017, Issue 2

The use both generics and biosimilars offers the potential to increase availability of medicines through decreases in cost that should occur when an expensive product (drug) loses patent protection and...

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2017.0602.011

2.818 views

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Pharma News

Published on 10 February 2017

Top developments in biosimilars during 2016

Submitted: 27 January 2017; Revised: 31 January 2017; Accepted: 1 February 2017; Published online first: 6 February 2017 Previous years have been momentous for biosimilars [1] and 2016 is no...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2017.0601.010

7.398 views

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Opinion

Published on 01 March 2017

Austrian medicines authority positive towards biosimilar interchangeability

Abstract: Clinical evidence supporting biosimilar use is growing and for the first time, the Austrian Medicines and Medical Devices Agency takes a positive position on interchangeability. They now state that...

Author(s): Christoph Baumgärtel, MD, MSc

Austria, biosimilars, interchangeability

DOI: 10.5639/gabij.2017.0601.009

9.467 views

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Meeting Report

Published on 14 December 2016

Biosimilar product labels in Europe: what information should they contain?

Abstract: In 2016, a multi-stakeholder workshop was held on the topic of ‘Biosimilar Labelling’. The discussions concerning labelling particulars are outlined in this meeting report. Submitted: 21 November 2016; Revised:...

Author(s): GaBI Journal Editor

biosimilar, labelling, patients, pharmacists, physicians, Summary of Product Characteristics (SmPC)

DOI: 10.5639/gabij.2017.0601.008

9.365 views

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Meeting Report

Published on 01 March 2017

Roundtable on biosimilars: pharmacovigilance, traceability, immunogenicity, 15 November 2016, Madrid, Spain

Author byline as per print journal: Professor Francisco José de Abajo, MD, MPH, PhD; Professor Joan Albanell, MD; Olga Delgado Sanchez, PharmD; Kevin Klein, MSc; José Vicente Moreno-Muelas, MD; Sol Ruiz, PhD; Professor...

Author(s): José Vicente Moreno-Muelas, MD, Kevin Klein, PhD, Olga Delgado Sanchez, PharmD, Professor Francisco José de Abajo, MD, MPH, PhD, Professor Francisco Zaragozá, PhD, Professor Joan Albanell, MD, Professor Maria Jesús Sanz Ferrando, PhD, Robin Thorpe, PhD, FRCPath, Sol Ruiz, PhD

biologicals, immunogenicity, interchangeability, pharmacovigilance, Spain, traceability

DOI: 10.5639/gabij.2017.0601.007

8.508 views

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Special Report

Published on 23 January 2017

Patent expiry dates for biologicals: 2016 update

Abstract: Biosimilars have been approved in Europe since 2006 and in the US since 2015. With patents on originator biologicals expiring and ever-tightening healthcare budgets, biosimilars are expected to take...

Author(s): GaBI Journal Editor

biological, biosimilar, patent

DOI: 10.5639/gabij.2017.0601.006

26.943 views

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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

8.130 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

17.837 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

10.379 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

9.548 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

3.146 views

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