Articles

Meeting Report

Published on 01 March 2017

Roundtable on biosimilars: pharmacovigilance, traceability, immunogenicity, 15 November 2016, Madrid, Spain

Author byline as per print journal: Professor Francisco José de Abajo, MD, MPH, PhD; Professor Joan Albanell, MD; Olga Delgado Sanchez, PharmD; Kevin Klein, MSc; José Vicente Moreno-Muelas, MD; Sol Ruiz, PhD; Professor...

Author(s): José Vicente Moreno-Muelas, MD, Kevin Klein, PhD, Olga Delgado Sanchez, PharmD, Professor Francisco José de Abajo, MD, MPH, PhD, Professor Francisco Zaragozá, PhD, Professor Joan Albanell, MD, Professor Maria Jesús Sanz Ferrando, PhD, Robin Thorpe, PhD, FRCPath, Sol Ruiz, PhD

biologicals, immunogenicity, interchangeability, pharmacovigilance, Spain, traceability

DOI: 10.5639/gabij.2017.0601.007

8.510 views

Read more →

Review Article

Published on 28 May 2013

The need for distinct nomenclature for originator and biosimilar products

Author byline as per print journal: Michael Sarshad, BSc, MBA; Rosanne Campbell, BComm, PGdip, MSc; Peter J Pitts, BA; Jacqueline anderpuye- Orgle, MSc, PhD Abstract: As the number of biosimilar...

Author(s): Jacqueline Vanderpuye-Orgle, MSc, PhD, Michael Sarshad, BSc, MBA, Rosanne Campbell, BComm, PGdip, MSc, Peter J Pitts, BA

biosimilars, Inflectra, International Nonproprietary Name (INN), naming, nomenclature, Zarxio

DOI: 10.5639/gabij.2018.0704.031

8.493 views

Read more →

Meeting Report

Published on 21 September 2016

First Turkish interactive workshop on regulation and approval of similar biotherapeutic products/biosimilars, 2–3 March 2016, Ankara, Turkey

Abstract: This paper discusses the findings and summary of items covered in the First Turkish interactive workshop on regulation and approval of similar biotherapeutic products/biosimilars, in which structure–function was highlighted...

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

glycosylation, immunogenicity, potency, receptor binding, serum half-life, sialic acid

DOI: 10.5639/gabij.2016.0503.034

8.474 views

Read more →

Original Research

Published on 29 September 2021

Extended stability of the trastuzumab biosimilar ABP 980 (KANJINTI™) in polyolefin bags and elastomeric devices

Author byline as per print journal: Lyndsay Davies1, PhD; Katie Milligan1, BSc; Mark Corris1, BSc; Ian Clarke1; Paul Dwyer1, MSc; Sarah Elizabeth Lee2, PhD; Jolene Teraoka3, BSc; Jill Crouse-Zeineddini3, PhD; Jane...

biosimilar, elastomeric device, KANJINTI® ABP 980, stability, trastuzumab

DOI: 10.5639/gabij.2021.1004.021

8.456 views

Read more →

Meeting Report

Published on 16 September 2015

European biosimilars conference highlights extrapolation as key issue

Abstract: This paper discusses topics covered by the EGA’s April 2015 biosimilars conference, where extrapolation of indications was highlighted as a key issue. Submitted: 2 July 2015; Revised: 15 July...

Author(s): GaBI Journal Editor

biosimilar, extrapolation, similarity

DOI: 10.5639/gabij.2015.0403.032

8.284 views

Read more →

Review Article

Published on 18 October 2023

Trends in Saudi FDA drug approvals and GMP inspections: an observational study

Author byline as per print journal: Ali M Alhomaidan, PhD; Mohammed Abdulaziz Alageel, MSc; Turki Abdulaziz Alrafie, MSc; Hassan Mohammed Alqarni, MSc; Ibraheem Yahya Khbrani, MSc; Dalal J Alkhamis, MSc;...

Common Technical Documents, drug regulation, good manufacturing practice, Saudi FDA

DOI: 10.5639/gabij.2023.1203.013

8.173 views

Read more →

Original Research

Published on 30 November 2020

Summative usability evaluation of the YLB113 etanercept biosimilar autoinjector via simulation

Author byline as per print journal: Kelly Canham1, BSc Hons; Claire Newcomb2, MSc Introduction/Study Objectives: Etanercept is a tumour necrosis factor inhibitor indicated for the treatment of several inflammatory disorders....

autoinjector, biosimilar, etanercept, usability, YLB113

DOI: 10.5639/gabij.2021.1002.006

8.147 views

Read more →

Perspective

Published on 14 December 2016

Pharmacovigilance of biosimilars and other biologicals within the hospital: current practices and future challenges

Author byline as per print journal: Barbara OM Claus, PharmD, PhD; Tiene Bauters, PharmD, PhD; Annemie Somers, PharmD, PhD Abstract: In the coming decade, many patents for biological pharmaceuticals will expire....

Author(s): Barbara OM Claus, PharmD, PhD, Professor Annemie Somers, PharmD, PhD, Tiene Bauters, PharmD, PhD

biologicals, biosimilars, hospitals, pharmacovigilance

DOI: 10.5639/gabij.2017.0601.005

8.130 views

Read more →

Pharma News

Published on 24 January 2014

Top developments in biosimilars during 2013

The past year has been a busy one for the biosimilars industry. Perhaps one of the most important milestones during 2013 was the European approval of the first monoclonal antibody...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2014.0301.014

8.088 views

Read more →

Original Research

Published on 07 January 2021

An assessment of trends in the Iranian pharmaceutical market following domestic production of selected medications (2007‒2017) and new considerations for health policymakers

Author byline as per print journal: Marzieh Zargaran1, PharmD, PhD Candidate; Abdol Majid Cheraghali 2,3, PharmD, PhD; Fatemeh Soleymani1,2, PharmD, MPH, PhD; Rajabali Daroudi4, BSc, MSc, PhD; Ali Akbari Sari4,...

Domestic production, Iranian health policy, medicines consumption, pharmaceutical industry, pharmaceutical market, trend analysis

DOI: 10.5639/gabij.2021.1001.003

7.895 views

Read more →

Meeting Report

Published on 03 July 2014

First GCC stakeholder meeting on approval process, interchangeability/substitution and safety of biosimilars 2017 – Report

Author byline as per print journal: Gianluca Trifirò, MD, PhD; Meteb Al-Foheidi, MD, FRCPC; Ali M Alhomaidan, PhD; Ahmed H Aljedai, PharmD, MBA, BCPS, FCCP, FAST; Musaed Abdullah Alkholief, PhD;...

Author(s): Ahmed H Aljedai, PharmD, MBA, BCPS, FCCP, FAST, Ali M Alhomaidan, PhD, Assistant Professor Gianluca Trifirò, MD, PhD, Aws Alshamsan, BPharm, RPh, PhD, Meteb Al-Foheidi, MD, FRCPC, Mohammad A Alsenaidy, MSc, PhD, Musaed Abdullah Alkholief, PhD, Professor Tore Kristian Kvien, MD

biologicals, biosimilars, GCC, interchangeability, regulatory, Saudi Arabia

DOI: 10.5639/gabij.2018.0704.032

7.874 views

Read more →