Abstract: Pharmacopoeias, as standard references for pharmaceutical drug specifi cations and reference standards in the form of monographs, play a pivotal role to assure drug quality and safety. With emphasis on the activities concerning non-biological complex drugs (NBCDs), the mechanisms by which new monographs are introduced into the European and the US pharmacopoeias are presented.…

Author(s): Professor Gerrit Borchard, PharmD, PhD

drug quality, ICH, non-biological complex drug (NBCD), Ph. Eur., pharmacopoeia, USP

DOI: 10.5639/gabij.2016.0501.009

Abstract: Low-cost generic drug programs (LCGPs) provide affordable generics in the US. However, LCGPs have implications for managed care organizations and researchers relying on claims data. Submitted: 7 March 2016; Revised: 5 April 2016; Accepted: 5 April 2016; Published online first: 18 April 2016 Low-cost generic drug programs (LCGPs) in the US increase the affordability…

Author(s): Joshua D Brown, PharmD, MS

generic medicines, low-cost generic drug programs, quality assessment, United States healthcare system

DOI: 10.5639/gabij.2016.0501.003

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 the most important milestone achieved during 2015 was the landmark decision made by the US Food and Drug Administration (FDA) on 6 March 2015 to…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2016.0501.010

Abstract: Biosimilars are highly similar versions of reference biological products, some with the potential to be deemed ‘interchangeable’ by medicines regulatory bodies, such as the US Food and Drug Administration. Biosimilar patent litigation continues to evolve as biosimilars enter new global markets. This manuscript is the second part of a manuscript that took a look…

Author(s): Brian J Malkin, Esq, Esq

351(k), Federal Circuit, interchangeable biosimilar, Japan Pharmaceuticals and Medical Devices Agency (PMDA), patent litigation linkage, subsequent entry biologics (SEBs)

DOI: 10.5639/gabij.2016.0502.016

Author byline as per print journal: Eric CK Siu1,4, MSc, PhD; Anne Tomalin2,4, BA, BSc; Kevin West3,4, BA; Sandra Anderson4, BA, MBA; George Wyatt1,4, BSc, MBA Abstract: Since the introduction of the first infliximab biosimilar, Inflectra®, significant changes have taken place in the Canadian biosimilar landscape, and both the regulatory and the reimbursement processes have…

Author(s): Anne Tomalin, BA, BSc, Eric CK Siu, MSc, PhD, George Wyatt, BSc, MBA, Kevin West, BA, Sandra Anderson, BA, MBA

biosimilars, CADTH CDR, CADTH pCODR, Health Canada, INESSS, pCPA

DOI: 10.5639/gabij.2019.0803.014

Author byline as per print journal: Ali M Alhomaidan, PhD; Ibrahim A Aljuffali, MSc, PhD; Fahad S Alnutaifi, MHEcon, MPH; Nasseruddeen A AL-Howaimel, MSc Abstract: Innovation in the pharmaceutical industry is expensive and risk must be rewarded. Some novel pharmaceuticals may be worth their high prices. Yet, high prices may hinder accessibility to novel products.…

Author(s): Ali M Alhomaidan, PhD, Fahad S Alnutaifi, MHEcon, MPH, Ibrahim A Aljuffali, MSc,PhD, Nasseruddeen A AL-Howaimel, MSc

biosimilar, prices, Saudi Arabia

DOI: 10.5639/gabij.2016.0501.007

Author byline as per print journal: Vito Annese, MD, PhD; Cristina Avendaño-Solá, MD, PhD; Professor Ferdinand Breedveld, MD; Niklas Ekman, PhD; Thijs J Giezen, MSc, PharmD, PhD; Professor Fernando Gomollón, MD, PhD; Research Professor Pekka Kurki, MD, PhD; Professor Tore Kristian Kvien, MD; Professor Andrea Laslop, MD; Professor Lluís Puig, MD, PhD; Robin Thorpe, PhD, FRCPath;…

Author(s): Adjunct Professor Pekka Kurki, MD, PhD, Cristina Avendaño-Solá, MD, PhD, Elena Wolff-Holz, MD, Martina Weise, MD, Niklas Ekman, PhD, Professor Andrea Laslop, MD, Professor Ferdinand Breedveld, MD, PhD, Professor Fernando Gomollón, MD, PhD, Professor Lluís Puig, MD, PhD, Professor Tore Kristian Kvien, MD, Robin Thorpe, PhD, FRCPath, Thijs J Giezen, PharmD, PhD, MSc, Vito Annese, MD

biologicals/biosimilars, extrapolation, interchangeability, medical societies, prescribers, regulators

DOI: 10.5639/gabij.2016.0502.019

Author byline as per print journal: Eleftheria Karampli, MSc; Estathia Triga, MSc; Vasiliki Tsiantou, MSc; Kostas Athanasakis, PhD; John Kyriopoulos, PhD Introduction/Study objectives: Generic medicines uptake is widely acknowledged as a key pharmaceutical policy measure towards cost containment and rational resource allocation. In Greece, due to the persistently low penetration of generics in the pharmaceutical…

Author(s): Eleftheria Karampli, MSc, Estathia Triga, MSc, John Kyriopoulos, PhD, Kostas Athanasakis, PhD, Vasiliki Tsiantou, MSc

generics, medicines consumption, patients, pharmaceutical policy, physicians, prescribing

DOI: 10.5639/gabij.2016.0501.005

Abstract: CT-P13 was the first infliximab biosimilar approved in Brazil. Approval was granted for all indications of the innovator. Despite similar efficacy and safety, vigilance remains essential. Submitted: 4 January 2016; Revised: 27 January 2016; Accepted: 1 February 2016; Published online first: 12 February 2016 On 27 April 2015, the Brazilian Health Surveillance Agency (Agência…

Author(s): Professor Fabio V Teixeira, MSc, MD, PhD

biosimilar, CT-P13, inflammatory bowel disease (IBD), infliximab

DOI: 10.5639/gabij.2016.0501.002

Contents Editor’s Letter Fourth and final issue of GaBI Journal’s fourth volume Commentary Bioequivalence of narrow therapeutic index drugs and immunosuppressives Original Research Prescribing practices for biosimilars: questionnaire survey findings from physicians in Argentina, Brazil, Colombia and Mexico Perspective Non-Biological Complex Drugs (NBCDs) and their follow-on versions: time for an editorial section Opinion Challenges of…

Contents Editor’s Letter Latest features in GaBI Journal, 2015, Issue 3 Editorial Advances in analytical characterization of biosimilars Letters to the Editor Access to safe and effective biopharmaceuticals Commentary The challenges of nomenclature – INN, biosimilars and biological qualifiers Review Article Biosimilars patent litigation in the EU and the US: a comparative strategic overview Biosimilars:…

Submitted: 15 December 2015; Revised: 15 December 2015; Accepted: 15 December 2015; Published online first: 16 December 2015 As a result of recent price increases and shortages, the US generics market has come under increasing scrutiny [1]. In a recent report by Wiske et al., authors from Brown, Duke and Harvard Universities discussed ways to…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2016.0501.011