Published on 04 April 2022
Biosimilar monoclonal antibodies development simplified
Author(s): Jennifer Campbell
1.487 views
Articles
Published on 04 April 2022
Sourcing innovator products in the age of biosimilar research
Author(s): Michael Cohan
Innovator drug sourcing challenges
1.258 views
Published on 04 April 2022
Next generation processing of monoclonal antibodies
Author(s): Christopher Gillespie, Jennifer Campbell, Michael Phillips
1.307 views
Published on 30 March 2022
Manufacture and regulation of cell, tissue and gene therapy products: global perspectives, challenges and next steps
Author byline as per print journal: Adjunct Associate Professor Sia Chong Hock, BSc (Pharm), MSc; Christine Koh, BSc (Pharm) (Hon); Associate Professor Chan Lai Wah, BSc (Pharm) (Hon), PhD Abstract: Cell,...
cell, good manufacturing practice, quality control, regulatory framework, tissue and gene therapy products
DOI: 10.5639/gabij.2022.1102.012
14.580 views
Published on 28 February 2022
Challenges in the manufacture, storage, distribution and regulation of traditional and novel vaccines
Author byline as per print journal: Adjunct Associate Professor Sia Chong Hock1, BSc (Pharm), MSc; Adelia Pheh1, BSc (Pharm) (Hon); Vimal Sachdeva2, MSc; Associate Professor Chan Lai Wah1, BSc (Pharm)...
challenges, COVID-19 vaccines, harmonization, manufacturing, regulation, traditional vaccines
DOI: 10.5639/gabij.2022.1101.004
10.367 views
Published on 28 January 2022
Biotherapeutic products in the European Pharmacopoeia: have all challenges been tackled?
Author byline as per print journal: Mihaela Buda, PhD; Olga Kolaj-Robin, PhD; Emmanuelle Charton, PhD Abstract: The approach to the elaboration of European Pharmacopoeia (Ph. Eur.) monographs in the field of...
biosimilars, biotherapeutics, monographs, pharmacopoeia, public standards
DOI: 10.5639/gabij.2022.1101.003
5.767 views
Published on 17 December 2021
Biosimilarity is not a transitive property: implication for interchangeability, naming and pharmacovigilance
Abstract: Current regulations do not require a given biosimilar to remain similar to its reference biological over time. However, two products that were initially deemed biosimilar or interchangeable could each...
Author(s): Pablo Matar, PhD
divergence, drift, evolution, interchangeability, pharmacovigilance, variability
DOI: 10.5639/gabij.2022.1101.006
4.661 views
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
6.735 views
Published on 17 December 2021
2021/4 GaBI Journal Table of Contents
Contents Editor’s Letter Fourth and final issue of GaBI Journal’s 10th volume Original Research Extended stability of the trastuzumab biosimilar ABP 980 (KANJINTI™) in polyolefin bags and elastomeric devices Review...
1.546 views
Published on 16 December 2021
Fourth and final issue of GaBI Journal’s 10th volume
This issue of the GaBI Journal contains only a limited number of articles, but these include two scientific very data-rich articles and an interesting and important expose on the use...
Author(s): Professor Philip D Walson, MD
DOI: 10.5639/gabij.2021.1004.020
1.852 views
Published on 03 December 2021
Biotechnological therapies and biosimilars for COVID-19: scarcities, poor regulation, and pharmaceutical black market: a case analysis in Ecuador
Author byline as per print journal: Esteban Ortiz-Prado1, MD, MSc, MPH, PhD(c); Enrique Teran2, MD, PhD; Raul Patricio Fernandez Naranjo1, MSc; Doménica Cevallos-Robalino1, MD; Eduardo Vasconez1, MD; Alex Lister3, MPH At...
biosimilars, black market, COVID-19 pandemic, interleukins, tocilizumab
DOI: 10.5639/gabij.2021.1004.023
10.156 views
Published on 29 September 2021
The European framework for intellectual property rights for biological medicines
Author byline as per print journal: Josette Sciberras, MBA, MA Bioethics, BPharm (Hons); Raymond Zammit, SThD; Patricia Vella Bonanno, PhD Introduction: The Pharmaceutical Strategy for Europe (2020) proposes actions related to...
biological medicines, European intellectual property rights, market access, pricing, R & D
DOI: 10.5639/gabij.2021.1004.022
10.836 views
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