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

Author byline as per print journal: Professor Philip J Schneider, MS, FASHP; Michael S Reilly, Esq Introduction: To date, the US Food and Drug Administration (FDA) has offered only draft guidance on the naming of biosimilar medicines. The Alliance for Safe Biologic Medicines (ASBM) has asked pharmacists for their views on the labelling and naming of…

Author(s): Michael S Reilly, Esq, Professor Philip J Schneider, MS, FASHP, FASPEN, FFIP

ASBM, biologicals, biosimilars, labelling, naming, US Food and Drug Administration (FDA)

DOI: 10.5639/gabij.2016.0504.040

Abstract: Physicians are pondering the clinical use of biosimilars. A reliance on clinical trials is deeply rooted in the modern healthcare system, whereas comparability and totality of evidence remain unknown concepts. This editorial explores these ideas, with reference to a case study of Italian gastroenterologists. Submitted: 24 October 2016; Revised: 1 November 2016; Accepted: 1…

Author(s): Adjunct Professor Pekka Kurki, MD, PhD

biosimilars, NOR-SWITCH, totality of evidence

DOI: 10.5639/gabij.2016.0504.039

Abstract: Effective pharmaceutical pricing policies in developing countries are important to ensure accessibility and affordability of essential medicines for the people. Submitted: 24 October 2016; Revised: 27 February 2017; Accepted: 28 February 2017; Published online first: 13 March 2017 In developing countries, essential medicines are not always available to those who need them because of…

Author(s): Nada Moustafa Abdel Rida, MSc Candidate, Professor Mohamed Izham Mohamed Ibrahim, PhD

developing countries, external reference pricing, government strategies, medicines, pharmaceutical pricing policy, price containment

DOI: 10.5639/gabij.2017.0601.002

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 last two decades. This is expected to lead to corresponding amelioration of the course of several immune-mediated diseases, including inflammatory bowel diseases (IBD). However, this…

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

Abstract: A study of the factors influencing generics makers’ decision on whether to enter a specific market found that firm size, market revenue and expected competition all had an effect. Market size was also positively associated with the entry of more generics. The effect of a financial subsidy on generics entry was also investigated. Submitted:…

Author(s): GaBI Journal Editor

financial subsidy, generics entry, generics market, price competition

DOI: 10.5639/gabij.2016.0503.037

Introduction: Canada is among the leading spenders in pharmaceuticals. Based on projected figures, the cost of pharmaceuticals is expected to rise by another 6–12% by 2023. Approximately CAN$4.6 billion of healthcare funding is spent on biological drugs (including growth factors and monoclonal antibodies) which are commonly used in the setting of haematology and blood and…

Author(s): Cherie C Severson, RN, MN, CON(C), BMTCN

biologicals, biosimilars, blood and marrow transplant, cost, haematology, subsequent entry biologics (SEBs)

DOI: 10.5639/gabij.2016.0503.032