Contents Editor’s Letter Fourth and final issue of GaBI Journal’s sixth volume Letters to the Editor Clear naming, traceability of biological medicines will protect patients Comment on the non-biological complex drugs paper Commentary Global policies on pharmacy-mediated substitution of biosimilars: a summary Original Research Pharmacy-mediated substitution of biosimilars – a global survey benchmarking country substitution…

Author byline as per print journal: Magaly Perez-Nieves1, MPH, PhD; Robyn K Pollom1, ANP; Ran Duan1, PhD; Samaneh Kabul1, PharmD; Amy M DeLozier1, MPH; Puneet Kaushik2, MPharm; Liza L Ilag1, MD Background: This analysis evaluates the patient-reported outcomes (PROs) in two randomized studies of biosimilar LY2963016 insulin glargine (LY IGlar) and Lantus® insulin glargine (IGlar),…

Author(s): Amy M DeLozier, MPH, Liza L Ilag, MD, Magaly Perez-Nieves, MPH, PhD, Puneet Kaushik, MPharm, Ran Duan, PhD, Robyn K Pollom, ANP, Samaneh Kabul, PharmD

biosimilar, follow-on biological, glargine, patient-reported outcomes, type 1 diabetes mellitus, type 2 diabetes mellitus

DOI: 10.5639/gabij.2018.0702.012

Editor's Letter

Published on 15 December 2017

Fourth and final issue of GaBI Journal’s sixth volume

Change is inevitable but often resisted, including or even especially in medicine. Hand washing is still neglected 170 years after Semmelweis’ work, misuse of antibiotics persists 72 years after Fleming warned about it, and use of generics and biosimilars remains suboptimal. This final 2017 issue of the GaBI Journal deals with many of the barriers…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2017.0604.030

Submitted: 17 November 2017; Revised: 20 November 2017; Accepted: 22 November 2017; Published online first: 5 December 2017 The tumour necrosis factor (TNF) inhibitor infliximab is known to significantly improve the treatment of inflammatory autoimmune diseases such as Crohn’s disease, ulcerative colitis and rheumatoid arthritis. The high cost of biological originators, however, has meant that…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2017.0604.042

Abstract: This paper highlights differences between USA and Europe when it comes to the interchangeability of biosimilars. The lack of harmonization between USA and Europe may introduce confusion for stakeholders and biosimilars makers and could be delaying access to life-saving treatments. Submitted: 5 December 2017; Revised: 7 December 2017; Accepted: 8 December 2017; Published online…

Author(s): GaBI Journal Editor

biosimilar, EMA, interchangeability

DOI: 10.5639/gabij.2017.0604.039

Abstract: Comment on the Special Report by Professor Gerrit Borchard: Complexity in the making: non-biological complex drugs (NBCDs) and the pharmacopoeias, published in GaBI Journal, 2016;5(1):36-41. Submitted: 3 November 2017; Revised: 13 November 2017; Accepted: 15 November 2017; Published online first: 28 November 2017 We thank you for publishing the manuscript entitled ‘Complexity in the making: non-biological…

Author(s): Karthik Bodhinathan, PhD, MSM

Glatiramer acetate, multiple sclerosis, non-biological complex drug (NBCD)

DOI: 10.5639/gabij.2017.0604.032

Abstract: An extensive overview of policies related to pharmacy-mediated substitution of biosimilars across the world was carried out by Larkin et al. in 2017. The details of this are discussed in this commentary. Submitted: 17 November 2017; Revised: 28 November 2017; Accepted: 4 December 2017; Published online first: 15 December 2017 Introduction An extensive overview…

Author(s): Thijs J Giezen, PharmD, PhD, MSc

biosimilar, policy, regulation, substitution, switching

DOI: 10.5639/gabij.2017.0604.033

Introduction: Launched in 2015, Zarxio™ (filgrastim-sndz) was the first biosimilar to gain US Food and Drug Administration (FDA) approval. In contrast, the first biosimilar was launched in Europe in 2006. Objective: To identify key biosimilar sales and marketing trends and their drivers, this will enable best practices to be outlined for manufacturers looking to enter…

Author(s): Michael Sarshad, BSc, MBA

biosimilar, US Food and Drug Administration (FDA), Zarxio

DOI: 10.5639/gabij.2017.0604.035

Author byline as per print journal: Professor Pere Gascón, MD; Ruediger Jankowsky, PhD; Karsten Roth, PhD Abstract: Cinfa Biotech, the biosimilars specialists of the Cinfa Group, reviewed pegfilgrastim biosimilar approaches to treat chemotherapy-induced neutropenia. Professor Dr Gascón discussed ’perspectives of pegfilgrastim’ and Dr Roth and Dr Jankowsky discussed why biosimilars are vital for oncology care. Submitted:…

Author(s): Karsten Roth, PhD, Professor Pere Gascón, MD, Ruediger Jankowsky, PhD

biosimilars, biotech, G-CSF, neutropenia, pegfilgrastim

DOI: 10.5639/gabij.2017.0604.040

Abstract: The European Commission held a stakeholder event to discuss biosimilar medicinal products in May 2017. A session on building stakeholder confidence in biosimilar medicines provided an update of the latest available clinical experiences with biosimilar medicines, focusing on switching between biological medicines and interchangeability. Assistant Professor Gianluca Trifirò from the University of Messina, Italy,…

Author(s): Assistant Professor Gianluca Trifirò, MD, PhD

best practice, biosimilar, interchangeability, pharmacovigilance, switching

DOI: 10.5639/gabij.2017.0604.038

Human immunodeficiency virus (HIV) patients in high-income countries are likely to accept the introduction of generic antiretroviral (ARV) drugs, according to a study carried out by researchers in Ireland [1]. Between July and August 2015, a survey of 66 patients was carried out in one-to-one interviews at St James Hospital, Dublin, Ireland. Descriptive and univariate…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2017.0604.041

Submitted: 19 June 2017; Revised: 5 September 2017; Accepted: 6 September 2017; Published online first: 19 September 2017 Introduction Comparative research on the European and US generic drug markets based on 2013 IMS data across 13 European countries with different generic drug policies has recently been accepted for publication in the Milbank Quarterly [1], and…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2017.0604.043