Articles

Abstracted Scientific Content

Published on 24 March 2014

Weighing up the cost of switching to biosimilars

It is far from clear whether off-patent biological medicines can offer the same cost savings as those offered by off-patent non-biological (chemically derived) medicines, write a group of Brussels-based health...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2014.0302.025

6.936 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

6.877 views

Read more →

Opinion

Published on 16 June 2015

Challenges of developing generics substitution policies in low- and middle-income countries (LMICs)

Abstract: There are few challenges to developing effective generics substitution policies in low- and middle-income countries (LMICs). These include the absence of generics substitution policies, lack of enforcement, lack of...

Author(s): Professor Mohamed Azmi Hassali, PhD, Zhi Yen Wong, BPharm (Hons), MSc (Pharmaceutical Policy), RPh

generic medicines, generics substitution, low- and middle-income countries (LMICs)

DOI: 10.5639/gabij.2015.0404.038

6.845 views

Read more →

Review Article

Published on 30 November 2020

An overview of the current status of follow-on biologicals in Iran

Author byline as per print journal: Farhang Rezaei, PharmD; Nassim Anjidani, PharmD Background: The advent of follow-on biologicals in Iran and biosimilars worldwide have provided various treatment options for several severe...

Author(s): Farhang Rezaei, PharmD, Nassim Anjidani, PharmD

biosimilars, Biotechnological therapeutics, follow-on biologics, Iran

DOI: 10.5639/gabij.2021.1002.010

6.828 views

Read more →

Commentary

Published on 14 December 2017

Global policies on pharmacy-mediated substitution of biosimilars: a summary

Abstract: An extensive overview of policies related to pharmacy-mediated substitution of biosimilars across the world was carried out by Larkin et al. in 2017. The details of this are discussed...

Author(s): Thijs J Giezen, PharmD, PhD, MSc

biosimilar, policy, regulation, substitution, switching

DOI: 10.5639/gabij.2017.0604.033

6.828 views

Read more →

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

6.762 views

Read more →

Original Research

Published on 23 February 2021

Biosimilars in Saudi Arabia: a single-centre, open-label case series examining infliximab switching

Author byline as per print journal: Mansour Somaily1, MD; Hana Alahmari1, MD; Wejdan Abbag2; Shahenda Yousif4, MD; Nawar Tayfour4, MD; Nouf Almushayt2; Saleh Alhusayni3, MD; Saeed Almajadiah4, MD Background: A...

Ankylosing spondylitis, Bechet's disease, CT-P13, infliximab, rheumatoid arthritis

DOI: 10.5639/gabij.2021.1002.007

6.759 views

Read more →

Letters to the Editor

Published on 17 December 2021

No need for systematic switch studies to demonstrate interchangeability of biosimilars

Abstract: Systematic clinical switch studies to demonstrate interchangeability of biosimilars are required in some jurisdictions while theoretical considerations and current clinical data question the feasibility and relevance of such studies....

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

biosimilars, immunogenicity, interchangeability, switch studies

DOI: 10.5639/gabij.2022.1101.002

6.752 views

Read more →

Meeting Report

Published on 16 December 2016

Data requirements to demonstrate biosimilarity in the EU

Abstract: How has the European Medicines Agency (EMA) changed its requirements for biosimilars since it first approved biosimilars in 2006? This is the question Dr Martina Weise, Head of Licensing...

Author(s): GaBI Journal Editor

biosimilar, biosimiliarity, data requirements, extrapolation

DOI: 10.5639/gabij.2016.0504.047

6.748 views

Read more →

Guidelines

Published on 06 May 2013

Update on clinical practice guideline on the use of epoetin and darbepoetin in adult patients with cancer

Abstract: Chemotherapy-induced anaemia can be treated using erythropoiesis-stimulating agents (ESAs), but these can cause serious side-effects including tumour progression, venous thromboembolism, and shorter survival. Following extensive review of recent literature,...

Author(s): GaBI Journal Editor

chemotherapy-induced anaemia, darbopoetin, epoetin, erythropoetin-stimulating agents, haemoglobin, thromboembolism

DOI: 10.5639/gabij.2013.0202.018

6.698 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

6.667 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

6.650 views

Read more →