Articles

Research News

Published on 17 October 2017

HIV patients will accept generic treatments

Human immunodeficiency virus (HIV) patients in high-income countries are likely to accept the introduction of generic antiretroviral (ARV) drugs, according to a study carried out by researchers in Ireland [1]....

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2017.0604.041

3.527 views

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Meeting Report

Published on 13 November 2017

Perspectives on the future of pegfilgrastim biosimilars

Author byline as per print journal: Professor Pere Gascón, MD; Ruediger Jankowsky, PhD; Karsten Roth, PhD Abstract: Cinfa Biotech, the biosimilars specialists of the Cinfa Group, reviewed pegfilgrastim biosimilar approaches to...

Author(s): Karsten Roth, PhD, Professor Pere Gascón, MD, Ruediger Jankowsky, PhD

biosimilars, biotech, G-CSF, neutropenia, pegfilgrastim

DOI: 10.5639/gabij.2017.0604.040

13.139 views

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Special Report

Published on 14 December 2017

USA and Europe differ in interchangeability of biosimilars

Abstract: This paper highlights differences between USA and Europe when it comes to the interchangeability of biosimilars. The lack of harmonization between USA and Europe may introduce confusion for stakeholders...

Author(s): GaBI Journal Editor

biosimilar, EMA, interchangeability

DOI: 10.5639/gabij.2017.0604.039

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Special Report

Published on 13 November 2017

Building stakeholder confidence in biosimilar medicines through evidence-based information sharing

Abstract: The European Commission held a stakeholder event to discuss biosimilar medicinal products in May 2017. A session on building stakeholder confidence in biosimilar medicines provided an update of the...

Author(s): Assistant Professor Gianluca Trifirò, MD, PhD

best practice, biosimilar, interchangeability, pharmacovigilance, switching

DOI: 10.5639/gabij.2017.0604.038

5.380 views

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Guidelines

Published on 06 September 2017

Biosimilars in Germany: guidance of the Drug Commission of the German Medical Association

Abstract: Biosimilars have been available in Europe for more than 10 years, but their adoption in Germany has not been very successful. As their pharmaceutical quality, efficacy (particularly in extrapolated...

Author(s): Professor Wolf-Dieter Ludwig, PhD, Stanislava Dicheva, PhD

biologicals, biosimilars, Germany, guidance, switching

DOI: 10.5639/gabij.2017.0604.037

15.727 views

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Perspective

Published on 17 October 2017

40th anniversary of essential medicines: a loud call for improving its access

Author byline as per print journal: Mohammad Bashaar, PhD; Professor Mohamed Azmi Hassali, PhD; Fahad Saleem, PhD Abstract: The soaring costs of medicine are a global dilemma. It was hoped that the...

Author(s): Fahad Saleem, Mohammad Bashaar, Professor Mohamed Azmi Hassali, PhD

access barriers, affordability, essential medicines, medicine prices

DOI: 10.5639/gabij.2017.0604.036

10.012 views

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Review Article

Published on 16 November 2017

Major lessons learned from Zarxio’s US launch: the start of a biosimilar revolution

Introduction: Launched in 2015, Zarxio™ (filgrastim-sndz) was the first biosimilar to gain US Food and Drug Administration (FDA) approval. In contrast, the first biosimilar was launched in Europe in 2006....

Author(s): Michael Sarshad, BSc, MBA

biosimilar, US Food and Drug Administration (FDA), Zarxio

DOI: 10.5639/gabij.2017.0604.035

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Original Research

Published on 06 September 2017

Pharmacy-mediated substitution of biosimilars – a global survey benchmarking country substitution policies

Introduction/Study objectives: Between March and May 2017, Pfizer conducted an internal global survey of 82 countries examining biosimilar pharmacy-mediated substitution to understand and benchmark the global policy landscape. Methods: Pfizer...

Author(s): Hannah Larkin, Judith Macdonald, Rebecca Lumsden, PhD

biosimilars, global, interchangeability, pharmacy, regulation, substitution

DOI: 10.5639/gabij.2017.0604.034

111.341 views

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Commentary

Published on 14 December 2017

Global policies on pharmacy-mediated substitution of biosimilars: a summary

Abstract: An extensive overview of policies related to pharmacy-mediated substitution of biosimilars across the world was carried out by Larkin et al. in 2017. The details of this are discussed...

Author(s): Thijs J Giezen, PharmD, PhD, MSc

biosimilar, policy, regulation, substitution, switching

DOI: 10.5639/gabij.2017.0604.033

6.804 views

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Letters to the Editor

Published on 14 December 2017

Comment on the non-biological complex drugs paper

Abstract: Comment on the Special Report by Professor Gerrit Borchard: Complexity in the making: non-biological complex drugs (NBCDs) and the pharmacopoeias, published in GaBI Journal, 2016;5(1):36-41. Submitted: 3 November 2017; Revised: 13...

Author(s): Karthik Bodhinathan, PhD, MSM

Glatiramer acetate, multiple sclerosis, non-biological complex drug (NBCD)

DOI: 10.5639/gabij.2017.0604.032

5.412 views

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Letters to the Editor

Published on 02 October 2017

Clear naming, traceability of biological medicines will protect patients

Author byline as per print journal: Adjunct Professor Valderilio Feijó Azevedo, MD, PhD, MBA; Associate Professor Brian Bressler, MD, MS, FRCPC; Madelaine A Feldman, MD, FACR; Professor Alejandro Mercedes, MD Abstract:...

Author(s): Alejandro Mercedes, MD, Associate Professor Valderilio Feijó Azevedo, MD, PhD, MSc, Brian Bressler, MD, Madelaine A Feldman, MD, FACR

Biological Qualifier (BQ), biosimilars, International Nonproprietary Name (INN), naming, pharmacovigilance, World Health Organization (WHO)

DOI: 10.5639/gabij.2017.0604.031

5.526 views

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Editor's Letter

Published on 15 December 2017

Fourth and final issue of GaBI Journal’s sixth volume

Change is inevitable but often resisted, including or even especially in medicine. Hand washing is still neglected 170 years after Semmelweis’ work, misuse of antibiotics persists 72 years after Fleming...

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2017.0604.030

3.024 views

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