Contents Editor’s Letter Latest features in GaBI Journal, 2017, Issue 3 Commentary Patent expiry and costs for anti­cancer medicines for clinical use Original Research A survey of Australian prescribers’ views on the naming and substitution of biologicals Review Article Biosimilars in Italy: what do real-world data reveal? Special Report Physician associations comment on FDA’s interchangeability…

Editor's Letter

Published on 27 September 2017

Latest features in GaBI Journal, 2017, Issue 3

It is clear that greater use of generics and biosimilars could greatly decrease healthcare costs and thereby increase availability of important medicines. It is equally clear that these potential savings are seldom achieved. The disconnect between what is possible and what is being achieved is related to a lack of trust on behalf of patients,…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2017.0603.020

Healthcare professionals working with HIV patients in high-income countries are likely to accept the introduction of generic antiretroviral drugs (ARVs), according to a study carried out by researchers in Ireland [1]. Between the end of August and November 2015, 30 healthcare professionals completed an online survey about the introduction of generic ARVs. Descriptive and univariate…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2017.0603.029

Submitted: 13 September 2017; Revised: 17 September 2017; Accepted: 18 September 2017; Published online first: 25 September 2017 Both pharmacists and doctors in Guatemala lack trust in generic medicines, according to a study carried out by a local non-governmental organization (NGO) [1]. The authors make recommendations for increasing generics uptake, including changing dispensing practices and…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2017.0603.028

Submitted: 30 January 2018; Revised: 8 February 2018; Accepted: 12 February 2018; Published online first: 26 February 2018 The past year has once again been a busy one for the biosimilars industry. Important milestones achieved during 2017 were the biosimilar approvals of Renflexis (infliximab-abda), Cyltezo (adalimumab-adbm), Mvasi (bevacizumab-awwb), Ixifi (infliximab-qbtx) and Ogivri (trastuzumab-dkst), along with…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2018.0701.008

Abstract: Biosimilars have been available in Europe for more than 10 years, but their adoption in Germany has not been very successful. As their pharmaceutical quality, efficacy (particularly in extrapolated indications), safety (especially immunogenicity) and interchangeability with reference products have been controversially discussed by healthcare professionals, the Drug Commission of the German Medical Association developed…

Author(s): Professor Wolf-Dieter Ludwig, PhD, Stanislava Dicheva, PhD

biologicals, biosimilars, Germany, guidance, switching

DOI: 10.5639/gabij.2017.0604.037

Introduction/Study objectives: Between March and May 2017, Pfizer conducted an internal global survey of 82 countries examining biosimilar pharmacy-mediated substitution to understand and benchmark the global policy landscape. Methods: Pfizer regulatory and corporate affairs colleagues completed a survey: Are pharmacists in your country able to substitute a biological with a biosimilar without the physician being…

Author(s): Hannah Larkin, Judith Macdonald, Rebecca Lumsden, PhD

biosimilars, global, interchangeability, pharmacy, regulation, substitution

DOI: 10.5639/gabij.2017.0604.034

Abstract: Comments from physician associations on the US Food and Drug Administration’s draft guidance on interchangeability of biosimilars are presented in this paper. Various issues were discussed; this paper highlights the comments on extrapolation, interchangeability, switching, labelling and naming, post-marketing and disease experts. Submitted: 2 June 2017; Revised: 13 June 2017; Accepted: 13 June 2017;…

Author(s): GaBI Journal Editor

biosimilar, extrapolation, interchangeability, labelling, switching, US Food and Drug Administration (FDA)

DOI: 10.5639/gabij.2017.0603.024

Contents Editor’s Letter What to look forward to in GaBI Journal, 2017, Issue 2 Editorial Trends and challenges in biosimilars pricing and reimbursement policies in Europe and beyond Commentary Strategies for pricing of pharmaceuticals and generics in developing countries Original Research What pricing and reimbursement policies to use for off-patent biologicals in Europe? – results…

Editor's Letter

Published on 12 June 2017

What to look forward to in GaBI Journal, 2017, Issue 2

The use both generics and biosimilars offers the potential to increase availability of medicines through decreases in cost that should occur when an expensive product (drug) loses patent protection and lower cost alternatives are marketed in countries with a ‘free-market’ economy. As the manuscripts in this issue of GaBI Journal emphasize, it is clear however…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2017.0602.011

Author byline as per print journal: Christoph Stoller; Professor Stephan Krähenbühl, MD, PhD; Emilia Minodora Voiculescu, PharmD Abstract: The Value Added Medicines Group of Medicines for Europe met at the 2017 European Association of Hospital Pharmacists conference in France to discuss the merits and future of these medicines. Submitted: 13 June 2017; Revised: 23 August 2017; Accepted:…

Author(s): Christoph Stoller, Emilia Minodora Voiculescu, PharmD, Professor Stephan Krähenbühl, MD, PhD

innovation, pharmacy regulation, value-added medicines

DOI: 10.5639/gabij.2017.0603.027

Author byline as per print journal: Professor Teun van Gelder, MD, PhD; Benedicte Lunddahl, DVM; Professor Barbara OM Claus, PharmD, PhD Abstract: The Medicines for Europe’s Biosimilar Medicines Group met at the 2017 European Association of Hospital Pharmacists conference in France to discuss pharmacovigilance, traceability and building trust in biosimilar medicines. Submitted: 22 May 2017; Revised: 21…

Author(s): Barbara OM Claus, PharmD, PhD, Benedicte Lunddahl, DVM, Professor Teun van Gelder, MD, PhD

biological, biosimilar, European Union, pharmacovigilance, regulatory, traceability

DOI: 10.5639/gabij.2017.0603.026