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

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

Abstract: How has the European Medicines Agency (EMA) changed its requirements for biosimilars since it first approved biosimilars in 2006? This is the question Dr Martina Weise, Head of Licensing Division at the Federal Institute for Drugs and Medical Devices (BfArM), discussed at the 14th Annual Biosimilar Medicines Group Conference. Submitted: 1 December 2016; Revised:…

Author(s): GaBI Journal Editor

biosimilar, biosimiliarity, data requirements, extrapolation

DOI: 10.5639/gabij.2016.0504.047

Author byline as per print journal: Omotayo Fatokun, PhD; Professor Mohamed Izham Mohamed Ibrahim, PhD; Professor Mohamed Azmi Hassali, PhD Abstract: There are major barriers to generic medicine development and market entry in Malaysia. This mixed method study recommends strategies to increase uptake. Submitted: 25 October 2016; Revised: 15 November 2016; Accepted: 21 November 2016; Published…

Author(s): Omotayo Fatokun, PhD, Professor Mohamed Azmi Hassali, PhD, Professor Mohamed Izham Mohamed Ibrahim, PhD

generic medicines, Malaysia, market entry, patent, pharmaceutical market

DOI: 10.5639/gabij.2016.0504.046

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

Abstract: The role of sound science, discovery, and innovation in value-added pharmaceuticals has not been sufficiently considered. This term is mainly used to define improved version of generic drugs. The concept of value-added pharmaceuticals has been picked up by different groups of companies, some are aiming to increase willingness to pay for their modified pharmaceutical…

Author(s): Fereshteh Barei, PhD

competitive advantage, generic pharmaceuticals, innovation, value-added pharmaceuticals

DOI: 10.5639/gabij.2016.0504.044