Articles

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

9.278 views

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Letters to the Editor

Published on 11 October 2012

A bioethicist’s view of the use of biosimilars

Abstract:  In recognition of the many ethically sensitive issues raised by the production and use of biosimilar medicinal products, the author imagines having to answer the non-multiple choice question ‘From...

Author(s): Carlo Petrini, PhD

bioethics, drugs, ethics committees, legislation, risk, safety

DOI: 10.5639/gabij.2012.0103-4.034

12.322 views

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Regulatory

Published on 20 August 2012

PMDA update: the current situation and future directions

Abstract: The Pharmaceuticals and Medical Devices Agency (PMDA) is a Japanese drug regulatory agency, sharing responsibilities with the Ministry of Health, Labour and Welfare. Its mission is to protect the...

Author(s): Yuki Ando, BA, Toshiyoshi Tominaga, PhD, Tatsuya Kondo, MD, PhD

approval review, international strategy, Japanese regulatory authority, PMDA, regulatory science, safety measure

DOI: 10.5639/gabij.2013.0201.013

20.198 views

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Editorial

Published on 02 August 2012

Generics policies–a globally-relevant implementation challenge

Abstract:  Vogler and Zimmerman, reporting on the 2011 Pharmaceutical Pricing and Reimbursement Information (PPRI) Conference, have noted the incomplete application of generics policies in many settings, and have called for...

Author(s): Andy Gray, MScPharm, FPS, FFIP

generics policies, transparency, WHO policy

DOI: 10.5639/gabij.2012.0103-4.027

26.525 views

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Perspective

Published on 01 August 2012

Health professionals in the risk communication process on counterfeit medicines

Abstract:  Communication is a key component in the fight against counterfeit medicines affecting the lives of patients. Two types of risk communication should be distinguished: pro-active and reactive. Reactive communication...

Author(s): Luc Besançon

counterfeit medicines, healthcare professionals, risk communication

DOI: 10.5639/gabij.2012.0103-4.026

14.923 views

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Guidelines

Published on 01 August 2012

ICH Q11: development and manufacture of drug substances–chemical and biotechnological/biological entities

Abstract:  The International Conference on Harmonisation (ICH) has endorsed a new guideline concerning the development and manufacture of chemical and biotechnological/biological drug substances. The guideline harmonises the scientific and technical...

Author(s): Keith McDonald, MSc, MRPharmS, Kowid Ho, PhD

biotechnological and chemical substances, drug substance quality, ICH Q11

DOI: 10.5639/gabij.2012.0103-4.025

35.942 views

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Readers' Comments

Published on 01 August 2012

A patient-centred paradigm for the biosimilars market

A patient-centred paradigm for the biosimilars market This article provides important insights into the use and application of complex biologicals, particularly biosimilars, in health delivery systems. One aspect of care that has...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2012.0102.024

5.294 views

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Abstracted Scientific Content

Published on 04 July 2012

Oncologists urged to embrace biosimilars to help control spiralling costs of cancer care

Oncologists urged to embrace biosimilars to help control spiralling costs of cancer care Oncologists have been urged to embrace biosimilar drug substitution to help control the spiralling costs of cancer care. However,...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2012.0102.022

7.808 views

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Regulatory

Published on 03 July 2012

Tighter EU rules on pharmacovigilance for biologicals

Received: 27 March 2012; Accepted: 22 May 2012 The new EU pharmacovigilance legislation which comes into force in July 2012 will include a tightening of requirements relating to product information and identification, as...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2012.0102.015

12.110 views

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Perspective

Published on 03 July 2012

Terminology for biosimilars–a confusing minefield

Author byline as per print journal: Robin Thorpe, PhD, FRCPath; Meenu Wadhwa, PhD Abstract:  Biosimilars are firmly established in the EU as copy biologicals with a clear and effective regulatory route for...

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

comparability, guidelines, non-innovator biologic, quality, safety

DOI: 10.5639/gabij.2012.0103-4.023

31.591 views

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