Articles

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

16.791 views

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Letters to the Editor

Published on 02 September 2014

Access to alternative biopharmaceuticals in low- and middle-income countries

Abstract: Alternative biopharmaceuticals could substantially improve affordability of biotherapeutics in developing countries. However, it seems that these countries need a modified regulatory pathway to guarantee timely access to these medicines....

Author(s): Professor Abdol Majid Cheraghali, PharmaD, PhD

affordability, alternative biopharmaceuticals, regulation

DOI: 10.5639/gabij.2014.0304.038

6.334 views

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Original Research

Published on 02 September 2014

Availability and procurement conditions of originator and generic medicines in hospitals – an exploratory study in five medium-sized European countries

Aim: To explore whether medicines used in hospitals in European countries are supplied as originators or generic medicines, and to investigate the procurement conditions, including the extent of discounts at...

Author(s): Sabine Vogler, PhD, Nina Zimmermann, MA, Jan Mazag, PharmaDr

cardiovascular medicines, discounts, generics, procurement, rebates, tender

DOI: 10.5639/gabij.2014.0304.040

10.932 views

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Meeting Report

Published on 03 July 2014

First GCC stakeholder meeting on approval process, interchangeability/substitution and safety of biosimilars 2017 – Report

Author byline as per print journal: Gianluca Trifirò, MD, PhD; Meteb Al-Foheidi, MD, FRCPC; Ali M Alhomaidan, PhD; Ahmed H Aljedai, PharmD, MBA, BCPS, FCCP, FAST; Musaed Abdullah Alkholief, PhD;...

Author(s): Ahmed H Aljedai, PharmD, MBA, BCPS, FCCP, FAST, Ali M Alhomaidan, PhD, Assistant Professor Gianluca Trifirò, MD, PhD, Aws Alshamsan, BPharm, RPh, PhD, Meteb Al-Foheidi, MD, FRCPC, Mohammad A Alsenaidy, MSc, PhD, Musaed Abdullah Alkholief, PhD, Professor Tore Kristian Kvien, MD

biologicals, biosimilars, GCC, interchangeability, regulatory, Saudi Arabia

DOI: 10.5639/gabij.2018.0704.032

7.859 views

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Original Research

Published on 03 July 2014

Barriers to market uptake of biosimilars in the US

Author byline as per print journal: Joshua P Cohen, PhD; Abigail E Felix, BA; Kim Riggs, MPH; Anumeha Gupta, MD Background: In the US, a new approval pathway for biosimilars has been established...

Author(s): Abigail E Felix, BA, Anumeha Gupta, MD, Joshua P Cohen, PhD, Kim Riggs, MPH

biosimilar, formulary, interchangeability, originator biological, payers, price discount, therapeutic switching

DOI: 10.5639/gabij.2014.0303.028

27.202 views

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Pharma News

Published on 16 June 2014

ECCO 2013 survey highlights lack of confidence in biosimilars

Results of a survey carried out by the European Crohn’s and Colitis Organisation (ECCO) highlight a lack of confidence in biosimilars and the need for continued education. The results of...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2014.0303.034

6.724 views

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Original Research

Published on 16 June 2014

Pricing of oral generic cancer medicines in 25 European countries; findings and implications

Author byline as per print journal: Brian Godman1,2,3,4, BSc, PhD; Andrew Hill5; Professor Steven Simoens6, MSc, PhD; Amanj Kurdi1,7, BSc, PhD; Jolanta Gulbinovič8, MD, PhD; Antony P Martin2,9; Angela Timoney1,10;...

Author(s): Brian Godman, BSc, PhD, Steven Simoens, MSc, PhD

cancer, Europe, generic drug regulations, generics, health policies, pricing

DOI: 10.5639/gabij.2019.0802.007

38.257 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

16.462 views

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Legal

Published on 16 June 2014

Biosimilars: considerations in light of the Italian legal framework

Abstract: Biological and biotechnological medicines are important pharmaceutical innovations due to their influence on the treatment of many conditions and because they have led the way in devising new and...

Author(s): Enrico Adriano Raffaelli, LLB, JD, Fausto Massimino, LLB, JD

advertising, biosimilars, competition, Italy, public tenders, scientific information

DOI: 10.5639/gabij.2019.0801.002

11.380 views

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Interview

Published on 16 June 2014

Biosimilars collaboration at Amgen and Actavis

Abstract: Representatives from Amgen and Actavis have spoken to GaBI (Generics and Biosimilars Initiative) about biosimilars. Topics covered included the clinical development of biosimilars, the need for further education, how...

Author(s): GaBI Journal Editor

biosimilar, clinical development, commercializaiton, INN

DOI: 10.5639/gabij.2014.0303.035

12.234 views

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Review Article

Published on 16 June 2014

Recommendations for the regulation of biosimilars and their implementation in Latin America

Author byline as per print journal: Valderilio Feijó Azevedo, MD, PhD; Eduardo Mysler, MD; Alexis Aceituno Álvarez, PharmD, PhD; Juana Hughes, MSc; Francisco Javier Flores-Murrieta, PhD, FCP; Eva Maria Ruiz de Castilla, MS, MAA, PhD...

Author(s): Alexis Aceituno Álvarez, PharmD, PhD, Associate Professor Valderilio Feijó Azevedo, MD, PhD, MSc, Eduardo Mysler, MD, Eva Maria Ruiz de Castilla, MS, MAA, PhD, Francisco Javier Flores-Murrieta, PhD, FCP, Juana Hughes, MSc

biological products, biosimilarity, biosimilars, Latin America, reference biotherapeutic product (RBP), regulatory pathways

DOI: 10.5639/gabij.2014.0303.032

31.535 views

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