Articles

Pharma News

Published on 26 March 2014

New EU guidance for the evaluation of medicinal products with modified drug release will be finished by the middle of 2014

Submitted: 2 March 2014; Revised: 7 March 2014; Accepted: 8 March 2014; Published online first: 21 March 2014 The guideline ‘Note for guidance on modified release oral and transdermal dosage...

Author(s): Christoph Baumgärtel, MD, MSc, Jan Neuhauser, MD

DOI: 10.5639/gabij.2014.0302.024

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Letters to the Editor

Published on 18 March 2014

Common or distinct INN for biosimilars? Only characteristics of the active substance prior to formulation should be considered

Submitted: 24 January 2014; Revised: 29 January 2014; Accepted: 30 January 2014; Published online first: 12 February 2014 To the Editor: I read with interest the letter of Dr Edward...

Author(s): Professor Paul J Declerck, PhD

DOI: 10.5639/gabij.2014.0301.003

9.631 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

9.616 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

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Special Report

Published on 21 September 2016

US FDA proposals for naming of biologicals and labelling of biosimilars

Abstract: There is considerable concern and debate over the naming of biologicals and labelling of biosimilars. To ensure that patients receive the safest and most effective treatment, it is paramount...

Author(s): GaBI Journal Editor

biologicals, biosimilars, labelling, naming, nomenclature, regulation

DOI: 10.5639/gabij.2016.0503.036

9.529 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

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Regulatory

Published on 26 October 2016

Regulatory Science Ireland: bridging the information gap on biosimilar medicines

Author byline as per print journal: Joan O’Callaghan, BSc Pharm; Sean Barry, PhD; Una Moore, PhD; Margaret Bermingham, PhD; J Michael Morris, PhD; Frank Hallinan, PhD; Brendan T Griffin, PhD Abstract: Regulatory...

Author(s): Brendan T Griffin, PhD, Frank Hallinan, PhD, J Michael Morris, PhD, Joan O’Callaghan, BSc Pharm, Margaret Bermingham, PhD, Sean Barry, PhD, Una Moore, PhD

biological medicines, biosimilar, Health Products Regulatory Authority, regulatory science, Regulatory Science Ireland

DOI: 10.5639/gabij.2016.0504.043

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Letters to the Editor

Published on 09 February 2016

First biosimilar of infliximab approved in Brazil: response from the Brazilian IBD society

Abstract: CT-P13 was the first infliximab biosimilar approved in Brazil. Approval was granted for all indications of the innovator. Despite similar efficacy and safety, vigilance remains essential. Submitted: 4 January...

Author(s): Professor Fabio V Teixeira, MSc, MD, PhD

biosimilar, CT-P13, inflammatory bowel disease (IBD), infliximab

DOI: 10.5639/gabij.2016.0501.002

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Regulatory

Published on 28 May 2015

Update on US state legislation on biosimilars substitution

Abstract: Since the biosimilars pathway was introduced, many US states have been considering, or have introduced, legislation to allow for substitution of biosimilars deemed interchangeable. This paper gives an update...

Author(s): GaBI Journal Editor

biologicals, biosimilars, legislation, notification, substitution

DOI: 10.5639/gabij.2015.0402.020

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Letters to the Editor

Published on 11 October 2012

A clinician’s view of the ethics of the use of biosimilars

Abstract:  Comment on the Letters to the Editor by Dr Carlo Petrini: A bioethicist’s view of the use of biosimilars Submitted: 8 October 2012; Revised: 9 October 2012; Accepted: 9 October 2012;...

Author(s): Dr Kalle Hoppu

DOI: 10.5639/gabij.2012.0103-4.035

9.283 views

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Editorial

Published on 15 December 2014

Availability and procurement of generics in hospitals among medium-sized European countries

Abstract: Dr Brian Godman reviews the paper by Vogler and co-authors on the procurement of generics or originators among European hospitals once multiple sources become available. Submitted: 28 November 2014;...

Author(s): Brian Godman, BSc, PhD

Europe, generics, hospitals, procurement

DOI: 10.5639/gabij.2014.0304.037

9.282 views

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