Articles

Review Article

Published on 05 September 2014

Safety assessment of biosimilars in Europe: a regulatory perspective

Abstract: Clinical safety is important during the development of a biosimilar. This paper provides an overview of the main aspects related to the safety assessment of biosimilars. The European Medicines...

Author(s): Christian K Schneider, MD, Thijs J Giezen, PharmD, PhD, MSc

biosimilar, clinical safety, immunogenicity, pharmacovigilance

DOI: 10.5639/gabij.2014.0304.041

13.745 views

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Meeting Report

Published on 11 December 2015

First MENA educational workshop on regulation and approval of similar biotherapeutic products/biosimilars, Dubai, United Arab Emirates, 1 September 2015

Introduction: Similar biotherapeutic products (SBPs or biosimilars) include a rapidly expanding number of therapeutic products worldwide. However, agreement about the best practices for their regulation are lacking in many countries...

Author(s): Professor Philip D Walson, MD, Robin Thorpe, PhD, FRCPath

biologicals, biosimilars, follow-on drugs, MENA (Middle East, North Africa), North Africa), regulatory practice

DOI: 10.5639/gabij.2015.0404.039

13.661 views

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Letters to the Editor

Published on 18 April 2013

Challenges to generic medicines utilization in Yemeni healthcare system

Abstract: Generic medicines are promoted in many countries as an essential part of the healthcare system. However, in Yemen, there are many challenges to the utilisation of generic medicines. Currently,...

Author(s): Saleh Karamah AL-Tamimi, BPharm, MPharm (ClinPharm), Mohamed Azmi Ahmad Hassali, PhD, Alian A Alrasheedy, BPharm(Hons), MPharm(Clin), BCPS

challenges, consumers, generic medicines, healthcare professionals, Yemen

DOI: 10.5639/gabij.2013.0202.017

13.611 views

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Review Article

Published on 25 March 2020

Current trends for biosimilars in the Latin American market

Author byline as per print journal: Esteban Ortiz-Prado1,2, MD, MSc, MPH, PhD; Jorge Ponce-Zea3, MSc; Jorge E Vasconez1, MD; Diana Castillo,1, MD; Diana C Checa-Jaramillo1, MD; Nathalia Rodrí­guez-Burneo1, MD; Felipe...

biologicals, biopharmaceuticals, biosimilars, Latin America

DOI: 10.5639/gabij.2020.0902.011

13.385 views

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Editorial

Published on 29 October 2013

Suggested evaluation of biological drugs role for WHO – Editor’s response

Abstract: The Editor-in-Chief expresses his concerns about the proposal of a WHO run system to approve copy biologicals in the Milani and Gaspani paper [1]. The paper by Milani and...

Author(s): Professor Philip D Walson, MD

biological products, pegylated interferons, WHO

DOI: 10.5639/gabij.2013.0204.043

13.307 views

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Pharma News

Published on 27 June 2016

Switching from the infliximab reference product to CT-P13 in patients with rheumatoid arthritis or ankylosing spondylitis: results of the PLANETAS and PLANETRA extension studies

Submitted: 24 May 2016; Revised: 8 June 2016; Accepted: 10 June 2016; Published online first: 24 June 2016 CT-P13, also known by its brand names Remsima or Inflectra, is a...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2016.0502.023

13.301 views

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Pharma News

Published on 07 February 2013

‘Similar biologics’ approved and marketed in India

There have been established guidelines for approving generic versions of small molecule chemical drugs in India for some time already. However, no specific guidelines for ‘similar biologics’, as the Indian...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2013.0201.006

13.207 views

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Review Article

Published on 12 June 2017

Biosimilars in Italy: what do real-world data reveal?

Author byline as per print journal: Assistant Professor Gianluca Trifirò, MD, PhD; Ylenia Ingrasciotta, MSc; Ilaria Marcianò, MSc; Armando A Genazzani, DPhil, MD Abstract: This paper aims to provide an overview...

Author(s): Armando A Genazzani, DPhil, MD, Assistant Professor Gianluca Trifirò, MD, PhD, Ilaria Marcianò, MSc, Ylenia Ingrasciotta, MSc

biosimilars, comparative effectiveness, healthcare administrative databases, real world data, switching

DOI: 10.5639/gabij.2017.0603.023

13.161 views

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Commentary

Published on 11 October 2012

The case for biosimilars–a payer’s perspective

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

Author(s): Gustaf Befrits

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

DOI: 10.5639/gabij.2013.0201.009

13.004 views

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Regulatory

Published on 06 February 2015

Health Canada’s perspective on the clinical development of biosimilars and related scientific and regulatory challenges

Abstract: Biologicals have offered a new avenue for targeting therapy to treat life-threatening and chronic diseases. The recent or pending patent expirations of many successful biologicals have permitted the marketing...

Author(s): Agnes V Klein, MD, DPH, Jian Wang, MD, PhD, Ally Pen, PhD

biologicals, biosimilars, clinical trials, extrapolation, immunogenicity, regulatory

DOI: 10.5639/gabij.2015.0401.009

12.952 views

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