Articles

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

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Meeting Report

Published on 14 September 2023

Medicare drug price negotiations: impact on healthcare development and patient access to medicines

Author byline as per print journal: Michael S Reilly, Esq; Thomas R Barker, Esq, JD; Charles M Clapton, Esq; Steven J Potts, PhD, MBA; Andrew Spiegel, Esq Introduction: In the...

DOI: 10.5639/gabij.2023.1203.015

7.780 views

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Abstracted Scientific Content

Published on 04 July 2012

Oncologists urged to embrace biosimilars to help control spiralling costs of cancer care

Oncologists urged to embrace biosimilars to help control spiralling costs of cancer care Oncologists have been urged to embrace biosimilar drug substitution to help control the spiralling costs of cancer care. However,...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2012.0102.022

7.773 views

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Commentary

Published on 26 October 2016

Potential changes to the FDA approach to biosimilars have a global impact

Abstract: The Opinion article of Niazi urges the US Food and Drug Administration (FDA) to make adjustments to its guidance on biosimilar development. This article comments on some of the...

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

automatic substitution, FDA guidelines, global reference product, information, interchangeability, regulatory harmonization

DOI: 10.5639/gabij.2018.0702.011

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Editorial

Published on 29 June 2016

Adjusted indirect comparisons between generics – bioequivalence and interchangeability

Abstract: Adjusted indirect comparisons are valuable to establish the bioequivalence and thereby the interchangeability between generic drug products. Limitations should be observed especially when several generics of a drug are...

Author(s): Professor Laszlo Endrenyi, PhD, DSc, Professor László Tóthfalusi, MSc, PhD

adjusted indirect comparisons, bioequivalence, generic medicines, interchangeability, multiple generic products, switchability

DOI: 10.5639/gabij.2016.0502.014

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Pharma News

Published on 15 March 2016

Top developments in biosimilars during 2015

Submitted: 14 January 2016; Revised: 26 January 2016; Accepted: 27 January 2016; Published online first: 9 February 2016 Once again the biosimilars industry has had a busy year [1]. Perhaps...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2016.0501.010

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Original Research

Published on 01 June 2018

In vitro analytical and antibiotic comparison of generic moxifloxacin against E. coli and S. aureus bacteria strains

Author byline as per print journal: Auxiliary Professor Antistio Alviz-Amador1, MSc, Pharmaceutical Chemist; Jairo E Mercado Camargo2, MSc; Marlene Duran-Lengua3, MSc, PhD, Bacteriologist Introduction: Moxifloxacin is a quinolone antibiotic often used to treat...

Author(s): Antistio Alviz-Amador, MSc, Jairo E Mercado Camargo, MSc, Marlene Duran-Lengua, MSc, PhD

antibiotic resistance, Colombia, E. coli, moxifloxacin, S. aureus

DOI: 10.5639/gabij.2018.0703.024

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Opinion

Published on 05 January 2023

Biosimilars drug development: time for a paradigm shift?

Author byline as per print journal: Sandeep N Athalye, MBBS, MD; Shivani Mittra, MPharm, PhD; Ankitkumar M Ranpura, MD Abstract: The sky-rocketing cost of developing biosimilars is becoming a shared...

biosimilars, immunogenicity, interchangeability, switch studies

DOI: 10.5639/gabij.2023.1201.005

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Abstracted Scientific Content

Published on 06 July 2016

Investigating the validity of biosimilar extrapolation and interchangeability

Submitted: 30 June 2016; Revised: 1 July 2016; Accepted: 1 July 2016; Published online first: 4 July 2016 The European Medicines Agency’s (EMA) decision to approve the use of CPT-13,...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2016.0502.022

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Pharma News

Published on 01 December 2014

Reducing the European healthcare budget with generics and biosimilars

The world market for medicinal products is expected to reach US$1 trillion in 2014. Global spending on medicines is expected to grow to nearly US$1.2 trillion by 2017 [1]. As...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2014.0304.046

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For Patients

Published on 19 October 2012

IAPO launched the Patient-Centred Healthcare Indicators Review

Submitted: 9 January 2013; Revised: 11 January 2013; Accepted: 15 January 2013; Published online first: 22 January 2013 In October 2012, the International Alliance of Patients’ Organizations (IAPO) launched its final Patient-Centred Healthcare Indicators Review and accompanying...

Author(s): Yasemin Dil

DOI: 10.5639/gabij.2013.0201.005

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