Abstract: Clinical evidence supporting biosimilar use is growing and for the first time, the Austrian Medicines and Medical Devices Agency takes a positive position on interchangeability. They now state that prescribing biosimilars to treatment-naïve patients and even a change from originator to biosimilar is appropriate, provided it is done under physician’s supervision. Submitted: 9 January…

Author(s): Christoph Baumgärtel, MD, MSc

Austria, biosimilars, interchangeability

DOI: 10.5639/gabij.2017.0601.009

Abstract: In 2016, a multi-stakeholder workshop was held on the topic of ‘Biosimilar Labelling’. The discussions concerning labelling particulars are outlined in this meeting report. Submitted: 21 November 2016; Revised: 23 January 2017; Accepted: 24 January 2017; Published online first: 6 February 2017 Introduction Labels on medicinal products contain information for pharmacists, physicians and patients.…

Author(s): GaBI Journal Editor

biosimilar, labelling, patients, pharmacists, physicians, Summary of Product Characteristics (SmPC)

DOI: 10.5639/gabij.2017.0601.008

Author byline as per print journal: Professor Francisco José de Abajo, MD, MPH, PhD; Professor Joan Albanell, MD; Olga Delgado Sanchez, PharmD; Kevin Klein, MSc; José Vicente Moreno-Muelas, MD; Sol Ruiz, PhD; Professor Maria Jesús Sanz Ferrando, PhD; Robin Thorpe, PhD, FRCPath; Professor Francisco Zaragozá, PhD Introduction: Biosimilars can offer a lower-cost alternative to current biological therapies and could…

Author(s): José Vicente Moreno-Muelas, MD, Kevin Klein, PhD, Olga Delgado Sanchez, PharmD, Professor Francisco José de Abajo, MD, MPH, PhD, Professor Francisco Zaragozá, PhD, Professor Joan Albanell, MD, Professor Maria Jesús Sanz Ferrando, PhD, Robin Thorpe, PhD, FRCPath, Sol Ruiz, PhD

biologicals, immunogenicity, interchangeability, pharmacovigilance, Spain, traceability

DOI: 10.5639/gabij.2017.0601.007

Abstract: Biosimilars have been approved in Europe since 2006 and in the US since 2015. With patents on originator biologicals expiring and ever-tightening healthcare budgets, biosimilars are expected to take an increasing share of the biologicals market. In light of these facts, this paper gives estimated patent expiry dates for just some of the best-selling…

Author(s): GaBI Journal Editor

biological, biosimilar, patent

DOI: 10.5639/gabij.2017.0601.006

Author byline as per print journal: Barbara OM Claus, PharmD, PhD; Tiene Bauters, PharmD, PhD; Annemie Somers, PharmD, PhD Abstract: In the coming decade, many patents for biological pharmaceuticals will expire. Consequently, the market for biosimilars has the potential to grow rapidly. For safety reasons, the more extensive use of a greater variety of biologicals increases…

Author(s): Barbara OM Claus, PharmD, PhD, Professor Annemie Somers, PharmD, PhD, Tiene Bauters, PharmD, PhD

biologicals, biosimilars, hospitals, pharmacovigilance

DOI: 10.5639/gabij.2017.0601.005

Author byline as per print journal: Anu Gore, PhD; Mayssa Attar, PhD; Chetan Pujara, PhD; Sesha Neervannan, PhD Abstract: Generic drugs are intended to provide a lower cost option of safe and effective medicines thereby granting greater patient access to affordable health care. A sound scientific basis and a robust regulatory process to demonstrate bioequivalence of…

Author(s): Anu Gore, PhD, Chetan Pujara, PhD, Mayssa Attar, PhD, Sesha Neervannan, PhD

dry eye, ocular, ophthalmic, safety, topical

DOI: 10.5639/gabij.2017.0601.004

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

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

Editor's Letter

Published on 08 March 2017

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

This first issue of 2017 includes a range of manuscripts of interest to readers. A Letter to the Editor from Professor Mohamed Izham Mohamed Ibrahim and Nada Moustafa Abdel Rida proposes steps that governments and international organizations have taken or need to do, especially with respect to pricing of pharmaceuticals, to make ‘Essential Medicines’ more…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2017.0601.001

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: 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

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