Articles

Commentary

Published on 22 January 2014

Defining and characterizing non-biological complex drugs (NBCDs) – Is size enough? The case for liposomal doxorubicin generics (‘liposomal nanosimilars’) for injection

Abstract: ‘Non-binding recommendations’ from regulatory bodies are in place for evaluation and production of generic liposomal doxorubicin injection. However, how these nano-sized generics (‘nanosimilars’) should be characterized and evaluated, and...

Author(s): Professor S Moein Moghimi, PhD, Z Shadi Farhangrazi, PhD

adverse reactions, complement system, immunogenicity, liposomes, nanoparticle size, vesicle morphology

DOI: 10.5639/gabij.2014.0302.017

23.015 views

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Review Article

Published on 22 January 2014

Clinical development, immunogenicity, and interchangeability of follow-on complex drugs

Abstract: Although not derived from living sources, non-biological complex drug (NBCD) products have the immunogenicity and molecular complexity of biological drugs. NBCDs typically contain heterogenous mixtures of closely related nanoparticulate...

Author(s): J Michael Nicholas, PhD

follow-on drugs, glatiramoids, iron-carbohydrate complexes, liposomes, non-biological complex drug (NBCD)

DOI: 10.5639/gabij.2014.0302.020

32.244 views

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Original Research

Published on 20 January 2014

Retrospective chart review: disrupted anaemia control in haemodialysis patients following the switch to an iron sucrose similar (ISS) after long-term treatment with the originator iron sucrose (IS)

Author byline as per print journal: Professor Jacques Rottembourg, MD; Corinne Emery, MSc; Alessandra Moglia, PhD Study objective: To describe and compare the haematological parameters and the anaemia medication use in...

Author(s): Alessandra Moglia, PhD, Corinne Emery, MSc, Jacques Rottembourg, MD

anaemia, cost, haemodialysis, interchangeability, iron sucrose, iron sucrose similar, non-biological complex drug (NBCD), oxidative stress

DOI: 10.5639/gabij.2014.0303.029

23.640 views

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Perspective

Published on 20 January 2014

How to realize the potential of off-patent biologicals and biosimilars in Europe? Guidance to policymakers

Author byline as per print journal: Steven Simoens, PhD; Claude Le Pen, PhD; Niels Boone, PharmD; Ferdinand Breedveld, MD, PhD; Antonella Celano; Antonio Llombart-Cussac, MD, PhD; Frank Jorgensen, MPharm, MM;...

Author(s): Ad A van Bodegraven, MD, PhD, Andras Süle, PhD, Antonella Celano, Antonio Llombart Cussac, MD, PhD, Frank Jorgensen, MPharm, MM, Jo De Cock, Niels Boone, PharmD, Professor Claude Le Pen, PhD, Professor Ferdinand Breedveld, MD, PhD, Rene Westhovens, MD, PhD, Steven Simoens, MSc, PhD

biologicals, biosimilars, competition, Europe, policy, sustainability

DOI: 10.5639/gabij.2018.0702.014

17.735 views

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Commentary

Published on 20 January 2014

The biosimilar name debate: what’s at stake for public health

Abstract: As the number of innovator biologics and biosimilars increases worldwide, a growing debate has focused on how these products should be named. The simple concept of a name can...

Author(s): Emily A Alexander, JD

adverse event reporting, biosimilars, naming

DOI: 10.5639/gabij.2014.0301.005

14.813 views

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Original Research

Published on 16 December 2013

Alternative statistical strategies for biosimilar drug development

Introduction: Many regulatory authorities have published requirements for the approval of biosimilar medicinal products. However, there is no guidance on which quantitative standards should be used to define how similar...

Author(s): Austin J Combest, PharmD, MBA, Song Wang, PhD, Brian T Healey, PharmD, MS, MBA, RAC, Dirk J Reitsma, MD

Bayesian design, biosimilar, drug development, repeated measures analysis, statistics strategy

DOI: 10.5639/gabij.2014.0301.006

17.353 views

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Abstracted Scientific Content

Published on 12 December 2013

Biosimilarity of anticancer monoclonal antibodies in the clinic

The European Medicines Agency recommends the use of pharmacodynamics (PD) markers when establishing biosimilarity, but no such biomarkers are known for the clinical efficacy of bevacizumab (Avastin). For this reason,...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2014.0301.013

6.580 views

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Editor's Letter

Published on 05 December 2013

GaBI Journal publishes four issues in 2013

This issue marks the forth and final issue of the second year’s edition of the GaBI Journal. The journal has grown rapidly through the combined efforts of the publisher and...

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2013.0204.042

11.620 views

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Abstracted Scientific Content

Published on 04 December 2013

Biosimilar monoclonal antibodies – time for a regulatory rethink

The approval of biosimilars in the European Union (EU) is governed by the EU biosimilar framework released in 2004. But new arrivals on the biosimilar stage – monoclonal antibodies –...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2013.0203.041

8.971 views

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