Articles

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

6.553 views

Read more →

Abstracted Scientific Content

Published on 21 April 2017

Generic prices estimated for four novel cancer drugs

Submitted: 13 March 2017; Revised: 15 March 2017; Accepted: 16 March 2017; Published online first: 29 March 2017 Generic drug manufacturing of four major cancer drugs could massively reduce their...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2017.0602.018

6.543 views

Read more →

Special Report

Published on 02 March 2023

Follow-on biologicals/biosimilars approved in Brazil: May 2023 update

Abstract: Brazilian requirements for approval of biosimilars are aligned with a strict regulatory process and ensure the same high standards of quality, safety and efficacy as for originator biologicals. Submitted:...

Author(s): Sílvia Helena Cestari de Oliveira, MSc

biologicals, biosimilars, Brazil

DOI: 10.5639/gabij.2023.1202.011

6.524 views

Read more →

Editor's Letter

Published on 19 April 2013

Editor’s introduction to the wide range of topics in the initial issue of the second volume of GaBI Journal

We start off the second year of GaBI Journal with articles covering a wide range of issues. In Letters to the Editor, Dr Christian K Schneider discusses and expands on...

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2013.0201.015

6.430 views

Read more →

Commentary

Published on 07 July 2020

Quality standards for biopharmaceuticals: the importance of good manufacturing practice

Abstract: Regulatory standards for recombinant DNA (rDNA)-derived medicinal products put in place over 40 years ago provided a framework for moving forward with novel biotechnologies and biosimilars leading to their...

Author(s): Elwyn Griffiths, DSc, PhD

ASEAN, biologicals, biosimilars, GMP, regulatory harmonization

DOI: 10.5639/gabij.2020.0903.017

6.374 views

Read more →

Editorial

Published on 26 October 2016

Physicians, Hippocrates and biosimilars: applying ancient principles in a modern society

Abstract: Physicians are pondering the clinical use of biosimilars. A reliance on clinical trials is deeply rooted in the modern healthcare system, whereas comparability and totality of evidence remain unknown...

Author(s): Adjunct Professor Pekka Kurki, MD, PhD

biosimilars, NOR-SWITCH, totality of evidence

DOI: 10.5639/gabij.2016.0504.039

6.364 views

Read more →

Perspective

Published on 03 October 2016

Are the perspectives regarding the use of biosimilars in the setting of haematology and blood and marrow transplant changing?

Introduction: Canada is among the leading spenders in pharmaceuticals. Based on projected figures, the cost of pharmaceuticals is expected to rise by another 6–12% by 2023. Approximately CAN$4.6 billion of...

Author(s): Cherie C Severson, RN, MN, CON(C), BMTCN

biologicals, biosimilars, blood and marrow transplant, cost, haematology, subsequent entry biologics (SEBs)

DOI: 10.5639/gabij.2016.0503.032

6.353 views

Read more →

Letters to the Editor

Published on 27 November 2013

Critical immunogenicity differences will be obscured by a common INN for biosimilars

Abstract: Information about variable immunogenicity arising from formulation differences between competing biosimilars is critical for informed judgments by prescribing physicians. Use of a common INN for biosimilars will obfuscate such...

Author(s): Edward T Maggio, PhD

immunogenicity, INN, neoantigen, neutralizing antibodies, oxidative damage, polysorbate, protein aggregation

DOI: 10.5639/gabij.2013.0204.046

6.335 views

Read more →

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

6.327 views

Read more →

Meeting Report

Published on 25 March 2015

First Latin American educational workshop on similar biotherapeutic products, Mexico City, Mexico, 20 January 2015

Introduction: Similar Biotherapeutic Products (SBPs or biosimilars) comprise a rapidly expanding area of therapeutics worldwide. However, best practices for their regulation are lacking in many Latin American countries. Methods: The...

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

biologicals, biosimilars, follow-on drugs, Latin America, Mexico, regulatory practice

DOI: 10.5639/gabij.2015.0403.031

6.261 views

Read more →

Abstracted Scientific Content

Published on 19 December 2018

US generic prescription drug markets 2004‒2016

Submitted: 6 December 2018; Revised: 12 December 2018; Accepted: 14 December 2018; Published online first: 19 December 2018 Generic drugs are currently central to disease treatment in the US. However,...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2018.0704.033

6.199 views

Read more →