Articles

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

9.545 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

8.561 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

7.432 views

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Abstracted Scientific Content

Published on 01 February 2017

Effective generics substitution

Submitted: 19 January 2017; Revised: 20 January 2017; Accepted: 23 January 2017; Published online first: 6 February 2017 In an article published in US Pharmacist [1] Manigault et al. emphasize...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2017.0602.019

5.107 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

27.082 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

17.996 views

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Published on 04 January 2017

2016/4 GaBI Journal Table of Contents

Contents Editor’s Letter Fourth and final issue of GaBI Journal’s fifth volume Editorial Physicians, Hippocrates and biosimilars: applying ancient principles in a modern society Original Research Naming and labelling of...

2.935 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

6.708 views

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Editor's Letter

Published on 16 December 2016

Fourth and final issue of GaBI Journal’s fifth volume

This fourth and final GaBI Journal issue of 2016 begins with the paper by Adjunct Professor Pekka Kurki about ‘applying ancient principles in a modern society’ in which he discusses...

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2016.0504.038

3.818 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

9.440 views

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Special Report

Published on 14 December 2016

Overview of the patent expiry of (non-)tyrosine kinase inhibitors approved for clinical use in the EU and the US

Author byline as per print journal: Subramanian Venkatesan, MSc; Associate Professor Martine Lamfers, PhD; Professor Sieger Leenstra, MD, PhD; Professor Arnold G Vulto, PharmD, PhD, FCP Abstract: Kinase inhibitors form the...

Author(s): Associate Professor Martine Lamfers, PhD, Professor Arnold G Vulto, PharmD, PhD, FCP, Professor Sieger Leenstra, MD, PhD, Subramanian Venkatesan, MSc

anticancer drugs, kinase inhibitors, market exclusivity, patent expiry, targeted therapies

DOI: 10.5639/gabij.2017.0602.016

60.397 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

8.155 views

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