Articles

Review Article

Published on 19 October 2012

Assessing biosimilarity and interchangeability of biosimilar products under the Biologics Price Competition and Innovation Act

Author byline as per print journal: Professor Shein-Chung Chow, PhD, Christine Ju, MSc Abstract: Biological (large molecule) drug products are made via living systems and are complex and variable in nature....

bioequivalence, biosimilarity, BPCIA, follow-on biologics, interchangeability

DOI: 10.5639/gabij.2013.0201.004

37.502 views

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Commentary

Published on 11 October 2012

The case for biosimilars–a payer’s perspective

Abstract:  Biosimilars have the potential for making savings in healthcare costs, and with resource allocation, if competition is permitted at the level of treatment induction. Submitted: 24 August 2012; Revised: 17 January 2013; Accepted: 4...

Author(s): Gustaf Befrits

biosimilar pharmaceuticals, biosimilars, EU, healthcare financing, substitution, Sweden

DOI: 10.5639/gabij.2013.0201.009

13.061 views

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Review Article

Published on 11 October 2012

Biosimilars in the European market

Author byline as per print journal: Professor Joan Rovira, PhD; Leandro Lindner, BSc; Emmanuel Giménez, BSc; Professor Jaime Espín, PhD; Antonio Olry de Labry, PhD; Leticia García, BSc Introduction and...

Author(s): Antonio Olry de Labry, PhD, Emmanuel Giménez, BSc, Leandro Lindner, BSc, Leticia García, BSc, Professor Jaime Espín, PhD, Professor Joan Rovira, PhD

biosimilars, European Union, market dynamics

DOI: 10.5639/gabij.2013.0201.012

26.742 views

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Perspective

Published on 11 October 2012

Why bioequivalence and unconditional interchangeability of generic drugs are not the same

Abstract: The patents for a number of cornerstone immunosuppressive drugs used in the field of solid organ transplantation have expired. Generic formulations are now available and several professional societies and...

Author(s): Professor Teun van Gelder, MD, PhD

bioequivalence, generics substitution, immunosuppression, transplantation

DOI: 10.5639/gabij.2013.0202.020

22.533 views

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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

9.282 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

12.337 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

20.240 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

26.544 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

14.939 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

36.025 views

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