Introduction: The US Food and Drug Association (FDA) released its requirements for the non-proprietary naming of biological products in January 2017. Before the FDA’s release, the Alliance for Safe Biologic Medicines (ASBM) asked physicians for their views on the labelling and naming of biosimilar medicines. Study objectives: To determine the opinions of physicians who prescribe…

Author(s): Harry L Gewanter, MD, FAAP, FACR, Michael S Reilly, Esq

ASBM, biosimilar, interchangeability, labelling, legislation, naming

DOI: 10.5639/gabij.2017.0601.003

Submitted: 1 December 2016; Revised: 6 December 2016; Accepted: 7 December 2016; Published online first: 12 December 2016 In Sweden, the government funds an insurance programme covering 75–80% of the cost of prescription drugs for patients. Since 2002, in an attempt to contain costs, pharmacists have had to inform consumers whether less expensive substitute products…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2016.0504.050

Abstract: European Pharmacopoeia (Ph. Eur.) monographs for biotherapeutic products have existed since the 1990s and remain the publicly available standard defining the quality of these medicines. Continued development of such monographs however faces considerable challenges in the current environment. This manuscript addresses what the main challenges are (complexity of biologicals, setting of specifications, relations with…

Author(s): Emmanuelle Charton, PhD

biotherapeutic products, complexity of biologicals, monographs, pharmacopoeia, public standards

DOI: 10.5639/gabij.2016.0504.045

Submitted: 28 November 2016; Revised: 29 November 2016; Accepted: 30 November 2016; Published online first: 5 December 2016 In the journal Blood, Jones et al. [1] discuss strategies used by brand pharmaceutical companies, often in combination, to delay market entry of affordable generic drugs in the US and other countries. They highlight how these strategies…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2016.0504.051

Submitted: 21 November 2016; Revised: 22 November 2016; Accepted: 24 November 2016; Published online first: 30 November 2016 Authors from the IRCCS – Istituto di Ricerche Farmacologiche ‘Mario Negri’, Milan, Italy discuss some of the most frequent concerns raised by internists (doctors of internal medicine) about biosimilars [1]. They also try to explain the scientific…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2016.0504.049

Submitted: 21 November 2016; Revised: 22 November 2016; Accepted: 24 November 2016; Published online first: 30 November 2016 A study of pharmacists investigated their perceptions of biosimilar naming conventions and the impact it might have on their dispensing habits [1]. The study found that pharmacists had a preference for distinguishable names. However, using the same…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2016.0504.048

Contents Editor’s Letter Latest features in GaBI Journal, 2016, Issue 3 Letters to the Editor Is the EU ready for non-biological complex drug products? Commentary Biosimilars: achieving long-term savings and competitive markets Review Article Current state of subsequent entry biologics (biosimilars) in Canada: a view from regulatory, reimbursement, clinician, and patient perspectives The generic medicines…

Author byline as per print journal: Jon SB de Vlieger, PhD; Professor Gerrit Borchard, PharmD, PhD; Vinod P Shah, PhD; Beat Flühmann, PhD; Sesha Neervannan, PhD; Professor Stefan Mühlebach, PhD Abstract: Comment on the Regulatory paper by Dr Falk Ehmann and Dr Ruben Pita: The EU is ready for non-biological complex medicinal products, published in…

Author(s): Beat Flühmann, PhD, Jon SB de Vlieger, PhD, Professor Gerrit Borchard, PharmD, PhD, Professor Stefan Mühlebach, PhD, Sesha Neervannan, PhD, Vinod P Shah, PhD

complex drug products, EMA, generics, harmonization, non-biological complex drug (NBCD), therapeutic equivalence, US Food and Drug Administration (FDA)

DOI: 10.5639/gabij.2016.0503.026

Editor's Letter

Published on 26 October 2016

Latest features in GaBI Journal, 2016, Issue 3

The informed, appropriate use of follow-on pharmacological agents can provide significant cost savings for patients and payers. These savings can then be used by governments and patients to increase access to health care. However, the actual savings realized depend on a complex series of factors including how ‘similar’ the products actually are to the innovator…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2016.0503.025

Author byline as per print journal: Joan O’Callaghan, BSc Pharm; Sean Barry, PhD; Una Moore, PhD; Margaret Bermingham, PhD; J Michael Morris, PhD; Frank Hallinan, PhD; Brendan T Griffin, PhD Abstract: Regulatory Science Ireland (RSI) is a voluntary network of interested parties from academia, the Health Products Regulatory Authority (HPRA), pharmaceutical and medical device industries and government…

Author(s): Brendan T Griffin, PhD, Frank Hallinan, PhD, J Michael Morris, PhD, Joan O’Callaghan, BSc Pharm, Margaret Bermingham, PhD, Sean Barry, PhD, Una Moore, PhD

biological medicines, biosimilar, Health Products Regulatory Authority, regulatory science, Regulatory Science Ireland

DOI: 10.5639/gabij.2016.0504.043

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 proposals from a global perspective, including the global reference product and the biosimilar comparability programme. FDA Commissioner Scott Gottlieb has stated that the biosimilar market…

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

Author byline as per print journal: Shyam Akku, MD; Amit Garg, MD; Suhas Khandarkar, MPharm Introduction: Majority of the Colombian population has become health insured leading to improved healthcare access in the country. Healthcare expenses have risen drastically, and cancer is responsible for the major disease burden. An option to reduce cost burden is to replace…

Author(s): Amit Garg, MD, Shyam Akku, MD, Suhas Khandarkar, MPharm

anticancer drugs, cost-minimization, generics, pharmacoeconomics

DOI: 10.5639/gabij.2016.0504.042