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

Submitted: 29 February 2016; Revised: 15 March 2016; Accepted: 16 March 2016; Published online first: 29 March 2016 Use of brand name drugs over generic equivalents after expiration of exclusivity still prevails. Ameet Sarpatwari and Aaron Kesselheim argue the case for reforming drug naming by allowing generic products to share the brand names of their…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2016.0501.012

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

Abstract: This paper describes the existing European Union legislation and scientific guidance to adequately assess the quality, safety and efficacy, as well as the lifecycle management, of the group of non-biological complex drug (NBCD) products, including nanomedicines such as liposomes, polymeric micelles, glatiramoids and iron-carbohydrate complexes. Submitted: 15 March 2016; Revised: 1 April 2016; Accepted:…

Author(s): Falk Ehmann, MD, PhD, MSc, Ruben Pita, PharmD, LLM

complex pharmaceutical forms, EMA, nanomedicines, regulatory science

DOI: 10.5639/gabij.2016.0501.008

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

Abstract: Hybridomas were developed in 1975 as a stable platform for creating monoclonal antibodies (mAbs). Over the past 40 years, hybridomas have been a leading platform for creating mAbs, yet of the 50 commercial mAbs approved for sale by the US Food and Drug Administration (FDA), only 18 are produced using hybridomas. Of the remainder,…

Author(s): Tim Steele, BS

hybridomas, microfluidics, monoclonal antibodies

DOI: 10.5639/gabij.2016.0501.006

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

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: 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

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

Abstract: The importance of obtaining IRB/EC consent for waiver of consent before embarking on retrospective chart review studies was highlighted using the recent case of a manuscript submitted to GaBI Journal. Submitted: 12 March 2016; Revised: 14 March 2016; Accepted: 14 March 2016; Published online first: 28 March 2016 This commentary was prompted by a…

Author(s): Professor Philip D Walson, MD

chart review, consent, retrospective, waiver

DOI: 10.5639/gabij.2016.0501.004

Editor's Letter

Published on 04 May 2016

Editor’s introduction to the initial issue of the fifth volume of GaBI Journal

This issue begins with a Letter to the Editor by Professor Fabio V Teixeira from the Brazilian Inflammatory Bowel Disease (IBD) Society that deals basically with the issue of extrapolation of indications. The letter states that ‘vigilance remains essential’ for the use of this agent in IBD patients. Professor Teixeira’s letter is in response to…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2016.0501.001