Articles

Regulatory

Published on 24 April 2013

Biosimilar development and regulation in Japan

Abstract: In Japan, biosimilars guidelines following the principles of the EU framework were established by Japan’s Ministry of Health, Labor and Welfare in March 2009. The guidelines cover the manufacturing...

Author(s): GaBI Journal Editor

biosimilar, Japan, regulatory

DOI: 10.5639/gabij.2013.0204.055

17.166 views

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Original Research

Published on 27 July 2016

Assessment of active pharmaceutical ingredients in drug registration procedures in Pakistan: implications for the future

Author byline as per print journal: Babar Khan, BPharm, MPH, PhD; Brian Godman, BSc, PhD; Ayesha Babar, BPharm, MPhil; Shahzad Hussain, BPharm, MPhil; Sidra Mahmood, PharmD, MSc; Tahir Aqeel, BPharm, MPhil...

Author(s): Ayesha Babar, BPharm, MPhil, Babar Khan, BPharm, MPH, PhD, Brian Godman, BSc, PhD, Shahzad Hussain, BPharm, MPhil, Sidra Mahmood, PharmD, MSc, Tahir Aqeel, BPharm, MPhil

API (active pharmaceutical ingredient), Drugs Regulatory Authority, generics, ibuprofen, Pakistan

DOI: 10.5639/gabij.2016.0504.041

17.151 views

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Review Article

Published on 04 April 2018

Protein heterogeneity and the immunogenicity of biotherapeutics

Abstract: High resolution analytical techniques reveal structural micro-heterogeneity within endogenous proteins, however, they are ‘seen’ as ‘self’ molecules by the immune system and immunological tolerance is established. In contrast the...

Author(s): Professor Roy Jefferis, PhD, DSc, MRCP, FRCPath

allotypes, erythropoietin, human IgG, idiotypes, immunogenicity, polymorphisms, post-translational modifications, structural heterogeneity

DOI: 10.5639/gabij.2018.0702.013

17.084 views

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Meeting Report

Published on 09 February 2016

Roundtable on biosimilars with European regulators and medical societies, Brussels, Belgium, 12 January 2016

Author byline as per print journal: Vito Annese, MD, PhD; Cristina Avendaño-Solá, MD, PhD; Professor Ferdinand Breedveld, MD; Niklas Ekman, PhD; Thijs J Giezen, MSc, PharmD, PhD; Professor Fernando Gomollón, MD,...

Author(s): Adjunct Professor Pekka Kurki, MD, PhD, Cristina Avendaño-Solá, MD, PhD, Elena Wolff-Holz, MD, Martina Weise, MD, Niklas Ekman, PhD, Professor Andrea Laslop, MD, Professor Ferdinand Breedveld, MD, PhD, Professor Fernando Gomollón, MD, PhD, Professor Lluís Puig, MD, PhD, Professor Tore Kristian Kvien, MD, Robin Thorpe, PhD, FRCPath, Thijs J Giezen, PharmD, PhD, MSc, Vito Annese, MD

biologicals/biosimilars, extrapolation, interchangeability, medical societies, prescribers, regulators

DOI: 10.5639/gabij.2016.0502.019

16.877 views

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Commentary

Published on 02 July 2012

Pharmacovigilance of biosimilars: challenges and possible solutions

Author byline as per print journal: Thijs J Giezen, PharmD, PhD; Sabine MJM Straus, MD, PhD Abstract:  Post-marketing surveillance is essential to detect, assess and prevent adverse reactions of chemically synthesized small...

Author(s): Sabine MJM Straus, MD, PhD, Thijs J Giezen, PharmD, PhD, MSc

biologicals, biosimilars, immunogenicity, pharmacovigilance, traceability

DOI: 10.5639/gabij.2012.0103-4.033

16.846 views

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Opinion

Published on 02 September 2014

Tell me the whole story: the role of product labelling in building user confidence in biosimilars in Europe

Abstract: The European Medicines Agency (EMA) has led the development of biosimilar regulatory pathways globally, tailoring their approach to meet the specific and scientifically determined needs of biosimilar development. However,...

Author(s): European Biopharmaceutical Enterprises

biosimilars, EMA (European Medicines Agency), labels, PIL (product information leaflet), Summary of Product Characteristics (SmPC)

DOI: 10.5639/gabij.2014.0304.043

16.810 views

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Editorial

Published on 05 August 2013

Italy’s final position paper on biosimilars and new price and reimbursement pathway

Abstract: The AIFA’s position paper recognizes the relevance of biosimilars to ensure the sustainability of drug expenditure but the new price and reimbursement procedure may not favour their prompt market...

Author(s): Gianluigi Casadei, MD

AIFA, biosimilars, market access, position paper, pricing, reimbursement

DOI: 10.5639/gabij.2013.0203.033

16.612 views

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Original Research

Published on 16 June 2014

Ongoing initiatives to improve prescribing efficiency in China; statins as a case history

Author byline as per print journal: Wenjie Zeng, BSc, PhD; Houmei Xi, B Eng; Brian Godman, BSc, PhD; Alexander E Finlayson, MD, MRCP;  Rickard E Malmstrom, MD, PhD Introduction: Pharmaceutical expenditure...

Author(s): Alexander E Finlayson, MD, MRCP, Brian Godman, BSc, PhD, Houmei Xi, B Eng, Rickard E Malmstrom, MD, PhD, Wenjie Zeng, BSc, PhD

China, drug utilization study, generics, health policies, pharmaceuticals, statins

DOI: 10.5639/gabij.2014.0303.030

16.500 views

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Special Report

Published on 18 November 2013

Analysis of European policy towards generic medicines

Abstract: In this paper, we provide an overview of a PhD project we undertook on European policy on generic medicines. In the course of our research, we identified various causes...

Author(s): Pieter Dylst, PharmD, Professor Arnold G Vulto, PharmD, PhD, FCP, Steven Simoens, MSc, PhD

demand-side policies, Europe, European policy, generic medicines, supply-side policies

DOI: 10.5639/gabij.2014.0301.011

16.473 views

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Perspective

Published on 06 August 2013

Assuring patient-centred care: engaging patients with rheumatoid arthritis in disease monitoring and pharmacovigilance

Abstract: With the advent of complex therapies in the form of biologicals, emerging biosimilars and non-biological complex drugs, monitoring for treatment related benefit and the potential for adverse effects is...

Author(s): Janet S Wyatt, RN, PhD, FAANP

biological therapy, patient engagement, pharmacovigilance, treatment response

DOI: 10.5639/gabij.2014.0301.008

16.443 views

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Original Research

Published on 03 August 2020

Physicochemical stability of the bevacizumab biosimilar, ABP 215, after preparation and storage in intravenous bags

Author byline as per print journal: Jolita Seckute1, PhD; Ingrid Castellanos2, PhD; Steven Bane1, PhD Study Objectives: To evaluate extended in-use stability of bevacizumab biosimilar, ABP 215, after dilution into...

ABP 215, administration, bevacizumab, biosimilar, infusion, stability

DOI: 10.5639/gabij.2020.0904.026

16.283 views

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Review Article

Published on 10 July 2018

Are there biosimilar orphan drugs for Gaucher disease? An overview in Mexico

Author byline as per print journal: G Castañeda-Hernández, PhD; L Carbajal-Rodríguez, MD; M Cerón-Rodríguez, MD; Professor LC Correa-González, MD; A Esquivel-Aguilar, PhD; SJ Franco-Ornelas, MD; JE García Ortiz, PhD; CM...

Author(s): A Esquivel-Aguilar, PhD, CM Hernández-Guadarrama, MD, E Terreros-Muñoz, MD, G Castañeda-Hernández, JE García Ortiz, PhD, JI Navarrete-Martínez, MD, L Carbajal-Rodríguez, MD, M Cerón-Rodríguez, MD, Professor LC Correa-González, MD, SJ Franco-Ornelas, MD, Y Santillán-Hernández

biosimilar, Gaucher disease, imiglucerase, non-originator imiglucerase, orphan drugs

DOI: 10.5639/gabij.2019.0802.008

16.240 views

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