Articles

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

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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

8.014 views

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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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Pharma News

Published on 24 March 2014

International Alliance of Patients’ Organizations toolkit for biological and biosimilar medicines

The International Alliance of Patients’ Organizations (IAPO) is an alliance of over 200 patient groups that represents the interests of patients worldwide. In November 2013, IAPO published its Information and...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2014.0304.045

7.881 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

7.871 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

7.811 views

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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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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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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 drugs, generic medicines, interchangeability, 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

7.646 views

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Original Research

Published on 03 February 2021

Variation in the prices of oncology medicines across Europe and the implications for the future

Author byline as per print journal: Brian Godman1,2,3, BSc, PhD; Steven Simoens4, MSc, PhD; Amanj Kurdi1,5, BSc, PhD; Gisbert Selke6; John Yfantopoulos7, PhD; Andrew Hill8, PhD; Jolanta Gulbinovič9, MD, PhD;...

cancer, cross-national, Europe, generics, health policies, pricing

DOI: 10.5639/gabij.2021.1002.008

7.643 views

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