Articles

For Patients

Published on 19 October 2012

IAPO launched the Patient-Centred Healthcare Indicators Review

Submitted:ย 9 January 2013;ย Revised:ย 11 January 2013;ย Accepted:ย 15 January 2013;ย Published online first:ย 22 January 2013 In October 2012, the International Alliance of Patientsโ€™ Organizations (IAPO) launched its final Patient-Centred Healthcare Indicators Review and accompanying...

Author(s): Yasemin Dil

DOI: 10.5639/gabij.2013.0201.005

7.518 views

Read more โ†’

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:ย 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

37.534 views

Read more โ†’

Commentary

Published on 11 October 2012

The case for biosimilarsโ€“a payerโ€™s perspective

Abstract:ย  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:ย 24 August 2012;ย Revised:ย 17 January 2013;ย Accepted:ย 4...

Author(s): Gustaf Befrits

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

DOI: 10.5639/gabij.2013.0201.009

13.073 views

Read more โ†’

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 Gimรฉnez, BSc; Professor Jaime Espรญn, PhD; Antonio Olry de Labry, PhD; Leticia Garcรญa, BSc Introduction and...

Author(s): Antonio Olry de Labry, PhD, Emmanuel Gimรฉnez, BSc, Leandro Lindner, BSc, Leticia Garcรญa, BSc, Professor Jaime Espรญn, PhD, Professor Joan Rovira, PhD

biosimilars, European Union, market dynamics

DOI: 10.5639/gabij.2013.0201.012

26.771 views

Read more โ†’

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

22.549 views

Read more โ†’

Letters to the Editor

Published on 11 October 2012

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

Abstract:ย  Comment on theย Letters to the Editorย by Dr Carlo Petrini: A bioethicistโ€™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

9.286 views

Read more โ†’

Letters to the Editor

Published on 11 October 2012

A bioethicist’s view of the use of biosimilars

Abstract:ย  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 โ€˜From...

Author(s): Carlo Petrini, PhD

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

DOI: 10.5639/gabij.2012.0103-4.034

12.348 views

Read more โ†’

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

20.281 views

Read more โ†’

Editorial

Published on 02 August 2012

Generics policiesโ€“a globally-relevant implementation challenge

Abstract:ย  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

26.553 views

Read more โ†’

Perspective

Published on 01 August 2012

Health professionals in the risk communication process on counterfeit medicines

Abstract:ย  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 Besanรงon

counterfeit medicines, healthcare professionals, risk communication

DOI: 10.5639/gabij.2012.0103-4.026

14.954 views

Read more โ†’