Articles

Original Research

Published on 16 December 2014

Differences in pharmacokinetic behaviour of branded enoxaparin and a US generic version in a non-human primate model

Author byline as per print journal: Professor Walter P Jeske, PhD; Jeanine M Walenga, PhD; Nicolas Simon, MD, PhD; Debra Hoppensteadt, PhD; Josephine Cunanan, MD; Vicki Escalante, BS; Jawed Fareed, PhD;...

Author(s): Debra Hoppensteadt, PhD, Jawed Fareed, PhD, Jeanine M Walenga, PhD, Josephine Cunanan, MD, Mamdouh Bakhos, MD, Nicolas Simon, MD, PhD, Vicki Escalante, BS, Professor Walter P Jeske, PhD

anticoagulation, generics, heparins, pharmacodynamics, pharmacokinetics, population

DOI: 10.5639/gabij.2015.0402.016

32.406 views

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Published on 26 March 2015

Online biosimilars resource for patients across Latin America

Submitted: 6 March 2015; Revised: 9 March 2015; Accepted: 10 March 2015; Published online first: 23 March 2015 A new online resource on biological and biosimilar medicines in Latin America...

Author(s): Ian Ford

DOI: 10.5639/gabij.2015.0402.021

5.247 views

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Commentary

Published on 24 March 2015

Pro-generics policies and the backlog in medicines registration in South Africa: implications for access to essential and affordable medicines

Abstract: The backlog in medicines registration in South Africa is a result of the implementation of pro-generics policies without strengthening the regulator to handle the substantial increase in registration applications...

Author(s): Allyson M Pollock, MBChB, FFPH, MRCP (Ed), MRCGP, Henry MJ Leng, PhD, David Sanders, MRCP

access to medicines, generic medicines registration, registration backlog, South Africa

DOI: 10.5639/gabij.2015.0402.014

21.355 views

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Editor's Letter

Published on 15 June 2015

What to look forward to in GaBI Journal, 2015, Issue 2

This entire issue of the GaBI Journal could be titled ‘World News’ since it contains manuscripts describing global generics and biosimilar activities. The Commentary by Leng et al. describes regulatory...

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2015.0402.013

3.551 views

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Abstracted Scientific Content

Published on 20 February 2015

Generics and off-patent biologicals for cancer treatment in developing countries

Submitted: 11 February 2015; Revised: 14 February 2015; Accepted: 15 February 2015; Published online first: 20 February 2015 Cancer represents a significant, and growing, burden on healthcare systems around the...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2015.0401.012

5.825 views

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Regulatory

Published on 06 February 2015

Health Canada’s perspective on the clinical development of biosimilars and related scientific and regulatory challenges

Abstract: Biologicals have offered a new avenue for targeting therapy to treat life-threatening and chronic diseases. The recent or pending patent expirations of many successful biologicals have permitted the marketing...

Author(s): Agnes V Klein, MD, DPH, Jian Wang, MD, PhD, Ally Pen, PhD

biologicals, biosimilars, clinical trials, extrapolation, immunogenicity, regulatory

DOI: 10.5639/gabij.2015.0401.009

13.091 views

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Review Article

Published on 26 March 2015

The refinement of the super generic concept: semantic challenge for product re-innovation?

Background: Uptake of super generic or hybrid pharmaceuticals has decelerated despite their important economic potential for the generic pharmaceutical industry. The aim of switching to these product portfolios was to...

Author(s): Fereshteh Barei, PhD, Malcolm Ross

505(b)(2) approvals, generics, improved therapeutics, innovation, new therapeutics entities, super generics

DOI: 10.5639/gabij.2015.0401.007

82.622 views

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Original Research

Published on 16 December 2014

Payer and physician evidence and discount requirements for biosimilars in three Latin American countries

Study objectives: In Latin America, many governments have attempted to address biosimilar safety and efficacy concerns by developing abbreviated regulatory pathways to increase access while controlling quality. This study explores...

Author(s): André Vidal Pinheiro, PhD, Associate Professor Valderilio Feijó Azevedo, MD, PhD, MSc, Daniele Severi Bruni, MPhil, Ronald Halbert, MD, MPH, Erik Sandorff, MA, MBA

biosimilar pharmaceuticals, discounts, drug industry, Latin America, prescribing

DOI: 10.5639/gabij.2015.0401.005

10.344 views

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Original Research

Published on 16 December 2014

What pricing and reimbursement policies to use for off-patent biologicals? – Results from the EBE 2014 biological medicines policy survey

Objective: One of the questions that the advent of biosimilars raises is whether the different nature of biological medicines would also imply the need for a different policy approach by...

Author(s): European Biopharmaceutical Enterprises

biological medicines, biosimilars, off-patent market, pricing and reimbursement policy

DOI: 10.5639/gabij.2015.0401.006

22.399 views

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Pharma News

Published on 06 March 2015

Top developments in biosimilars during 2014

Submitted: 10 February 2015; Revised: 24 February 2015; Accepted: 25 February 2015; Published online first: 6 March 2015 The past year has once again been a busy one for the...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2015.0401.010

11.721 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

7.435 views

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