Articles

Perspective

Published on 24 October 2016

Biosimilars in Italy: a gastroenterologist’s view

Author byline as per print journal: Vito Annese, MD; Tommaso Gabbani, MD; Antonio Luca Annese, MD Abstract: The introduction of biological therapy has revolutionized the paradigm of treatment in the...

Author(s): Antonio Luca Annese, MD, Tommaso Gabbani, MD, Vito Annese, MD

adalimumab, biosimilar, Crohn’s disease (CD), inflammatory bowel disease (IBD), switching, ulcerative colitis (UC)

DOI: 10.5639/gabij.2016.0503.033

7.432 views

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Abstracted Scientific Content

Published on 21 September 2015

Measuring performance in off-patent drug markets

Submitted: 10 July 2015; Revised: 13 August 2015; Accepted: 13 August 2015; Published online first: 26 August 2015 Generic medicines can play a role in curbing rising pharmaceutical costs, and...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2015.0404.042

7.418 views

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Published on 30 January 2015

Generics authorization – groundbreaking regulatory approach to closer international cooperation on the rise – IGDRP

Submitted: 24 January 2015; Revised: not applicable; Accepted: 27 January 2015; Published online first: 30 January 2015 The ‘International Generic Drug Regulators Pilot’ (IGDRP) seems to be a true model...

Author(s): Christoph Baumgärtel, MD, MSc, DI Dr Katharina Gazda-Pleban

DOI: 10.5639/gabij.2015.0401.011

7.391 views

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Pharma News

Published on 10 February 2017

Top developments in biosimilars during 2016

Submitted: 27 January 2017; Revised: 31 January 2017; Accepted: 1 February 2017; Published online first: 6 February 2017 Previous years have been momentous for biosimilars [1] and 2016 is no...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2017.0601.010

7.370 views

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Abstracted Scientific Content

Published on 14 November 2012

The potential for doctors to contribute to biosimilar guidelines

Many healthcare professionals remain concerned about the safety and efficacy of biosimilars, and are hence reluctant to prescribe them for patients, despite the publication of guidelines for their approval by...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2012.0103-4.039

7.369 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 policy, pricing

DOI: 10.5639/gabij.2021.1002.008

7.365 views

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Original Research

Published on 05 January 2023

Pharmacokinetics and relative bioavailability of sitagliptin hydrochloride and sitagliptin phosphate tablets formulations: a randomized, open-label, crossover study in healthy male volunteers

Author byline as per print journal: Chuei Wuei Leong1, PhD; Elton Sagim1, BBiomedSc, Kar Ming Yee1, BPharm; Muhammad Shalhadi Saharuddin1, BSc; Sharifah Radziah Syed Abd Rahim1, MSc; Khairil Sabri1, BSc;...

bioequivalence, new branded generics, sitagliptin hydrochloride, sitagliptin phosphate

DOI: 10.5639/gabij.2023.1201.004

7.303 views

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Regulatory

Published on 06 April 2018

Regulation of copy biologicals in China

Abstract: The first draft guidelines for copy biologicals were introduced in China back in 2014. The Technical Guideline was then updated and finalized in 2015. In this paper, how the...

Author(s): GaBI Journal Editor

biological, China, copy biological, regulation

DOI: 10.5639/gabij.2018.0702.015

7.288 views

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Meeting Report

Published on 19 January 2018

Quality assessment of biosimilars in Colombia – reducing knowledge gaps

Abstract: Biosimilar medicines are having a global effect, and as such regulatory agencies worldwide are assessing how to respond to them. Here, two events held by GaBI for the Colombian...

Author(s): Elaine Gray, PhD, Paul Matejtschuk, PhD, CChem, Robin Thorpe, PhD, FRCPath

biologicals, biosimilars, Colombia, quality assessment, regulatory aspects

DOI: 10.5639/gabij.2018.0702.017

7.201 views

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Pharma News

Published on 27 June 2016

The anti-TNF biosimilar CT-P13 had comparable efficacy to infliximab in rheumatoid arthritis over one year

Submitted: 24 May 2016; Revised: 8 June 2016; Accepted: 10 June 2016; Published online first: 24 June 2016 The introduction of biologicals has revolutionized the treatment of immune-mediated diseases such...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2016.0502.024

7.194 views

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