Articles

Review Article

Published on 05 January 2021

Continuous manufacturing versus batch manufacturing: benefits, opportunities and challenges for manufacturers and regulators

Author byline as per print journal: Adjunct Associate Professor Sia Chong Hock, BSc (Pharm), MSc; Teh Kee Siang, BSc (Pharm)(Hon); Associate Professor Chan Lai Wah, BSc (Pharm)(Hon), PhD Continuous manufacturing...

batch manufacturing, challenges, continuous manufacturing, harmonization, opportunity, regulatory

DOI: 10.5639/gabij.2021.1001.004

24.726 views

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Perspective

Published on 06 March 2013

Equivalence of generic medicines in general and immunosuppressants in particular – a regulatory opinion on switching of ciclosporin, tacrolimus and mycophenolate mofetil

Abstract: This position paper deals with our regulatory opinion on registered generic immunosuppressants such as ciclosporin, tacrolimus and mycophenolate mofetil, and provides arguments why these medicines are considered equally safe...

Author(s): Marc Maliepaard, PhD, Yang Yu, PharmD, Professor Hubert GM Leufkens, PharmD, PhD

bioequivalence, drug safety, generic, immunosuppression, regulation

DOI: 10.5639/gabij.2013.0202.019

24.547 views

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Review Article

Published on 13 April 2015

Generic pregabalin; current situation and implications for health authorities, generics and biosimilars manufacturers in the future

Author byline as per print journal: Brian Godman, BSc, PhD; Michael Wilcock, MPharm; Andrew Martin, MPharm; Scott Bryson, MSc, MPH; Christoph Baumgärtel, MD; Tomasz Bochenek, MD, MPH, PhD; Winne de Bruyn, BSc;...

Author(s): Brian Godman, BSc, PhD, et al.

generics, health authorities, Lyrica, pregabalin

DOI: 10.5639/gabij.2015.0403.028

24.219 views

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Original Research

Published on 07 July 2020

Qualitative survey-based evaluation of operability and convenience for the etanercept biosimilar YLB113 in a unique injection pen in patients with rheumatoid arthritis

Author byline as per print journal: Toshihiko Hibino1, MD; Tomohiko Yoshida2, MD, PhD; Akira Sagawa3, MD, PhD; Ikuko Masuda4, MD, PhD; Takaaki Fukuda5, MD Introduction/Study objective: Needle fear is common...

etanercept, injection pen, needle fear, rheumatoid arthritis, usability, YLB113

DOI: 10.5639/gabij.2020.0903.018

23.986 views

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Commentary

Published on 24 April 2013

Commentary on the recommendations of the European Society for Organ Transplantation Advisory Committee on generic substitution of immunosuppressive drugs

Abstract: In 2010, the Council of the European Society for Organ Transplantation formed an Advisory Committee to formulate recommendations on the use of generic drugs in solid organ transplant recipients....

Author(s): Professor Teun van Gelder, MD, PhD

ciclosporin, generics substitution, immunosuppression, mycophenolate, tacrolimus, transplantation

DOI: 10.5639/gabij.2013.0203.031

23.564 views

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Original Research

Published on 20 January 2014

Retrospective chart review: disrupted anaemia control in haemodialysis patients following the switch to an iron sucrose similar (ISS) after long-term treatment with the originator iron sucrose (IS)

Author byline as per print journal: Professor Jacques Rottembourg, MD; Corinne Emery, MSc; Alessandra Moglia, PhD Study objective: To describe and compare the haematological parameters and the anaemia medication use in...

Author(s): Alessandra Moglia, PhD, Corinne Emery, MSc, Jacques Rottembourg, MD

anaemia, cost, haemodialysis, interchangeability, iron sucrose, iron sucrose similar, non-biological complex drug (NBCD), oxidative stress

DOI: 10.5639/gabij.2014.0303.029

23.406 views

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Review Article

Published on 19 January 2018

The impact of religion on human embryonic stem cell regulations: comparison between the UK, Germany and the US

Author byline as per print journal: Hajaj M Alhomaidan; Ali M Alhomaidan, PhD Abstract: This paper describes the differences in human embryonic stem cell regulations in several Christian countries across...

Author(s): Ali M Alhomaidan, PhD, Hajaj M Alhomaidan

regulation, religion, stem cell

DOI: 10.5639/gabij.2018.0701.005

23.280 views

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Original Research

Published on 19 February 2020

Pharmaceutical pricing policy in Saudi Arabia: findings and implications

Introduction: Many countries have introduced policies and strategies to limit pharmaceutical expenditures. These include pharmaceutical pricing policies and related strategies to control medicine prices and to ensure appropriate and stable...

Author(s): Alian A Alrasheedy, BPharm(Hons), MPharm(Clin), PhD, MACP, RPh

health expenditures, medicine prices, pharmaceutical expenditure, pharmaceutical policy, pricing, Saudi Arabia

DOI: 10.5639/gabij.2020.0901.003

23.267 views

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Perspective

Published on 08 May 2012

Promoting access to biosimilars: a public−private partnership model for biosimilar development in underserved populations

Author byline as per print journal: Timothy Ken Mackey1,2, MAS; Professor Bryan A Liang1,3,4, MD, JD, PhD Abstract:  Biologicals represent the future of pharmaceutical treatments and innovation. Yet, emerging and developing...

Author(s): Professor Bryan A Liang, MD, JD, PhD, Timothy Ken Mackey, MAS

biosimilars, emerging markets, follow-on biologics, global health, immunogenicity, patient safety, public−private partnerships

DOI: 10.5639/gabij.2012.0102.018

23.227 views

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Review Article

Published on 16 November 2017

Major lessons learned from Zarxio’s US launch: the start of a biosimilar revolution

Introduction: Launched in 2015, Zarxio™ (filgrastim-sndz) was the first biosimilar to gain US Food and Drug Administration (FDA) approval. In contrast, the first biosimilar was launched in Europe in 2006....

Author(s): Michael Sarshad, BSc, MBA

biosimilar, US Food and Drug Administration (FDA), Zarxio

DOI: 10.5639/gabij.2017.0604.035

23.131 views

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Original Research

Published on 09 January 2018

Extended stability of a biosimilar of trastuzumab (CT-P6) after reconstitution in vials, dilution in polyolefin bags and storage at various temperatures

Author byline as per print journal: Victoire Vieillard, PharmD; Professor Alain Astier, PharmD, PhD; Muriel Paul, PharmD Objectives: This study assessed the long-term stability of the trastuzumab biosimilar CT-P6 (Herzuma®, Biogaran)...

Author(s): Muriel Paul, PharmD, Professor Alain Astier, PharmD, PhD, Victoire Vieillard, PharmD

biosimilar, extended stability, in-use stability, trastuzumab

DOI: 10.5639/gabij.2018.0703.022

23.045 views

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