Contents Editor’s Letter Fourth and final issue of GaBI Journal’s fourth volume Commentary Bioequivalence of narrow therapeutic index drugs and immunosuppressives Original Research Prescribing practices for biosimilars: questionnaire survey findings from physicians in Argentina, Brazil, Colombia and Mexico Perspective Non-Biological Complex Drugs (NBCDs) and their follow-on versions: time for an editorial section Opinion Challenges of…

Contents Editor’s Letter Latest features in GaBI Journal, 2015, Issue 3 Editorial Advances in analytical characterization of biosimilars Letters to the Editor Access to safe and effective biopharmaceuticals Commentary The challenges of nomenclature – INN, biosimilars and biological qualifiers Review Article Biosimilars patent litigation in the EU and the US: a comparative strategic overview Biosimilars:…

Submitted: 15 December 2015; Revised: 15 December 2015; Accepted: 15 December 2015; Published online first: 16 December 2015 As a result of recent price increases and shortages, the US generics market has come under increasing scrutiny [1]. In a recent report by Wiske et al., authors from Brown, Duke and Harvard Universities discussed ways to…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2016.0501.011

Pro-generics policies and the backlog in medicines registration in South Africa: implications for access to essential and affordable medicines Comment by Ernest Schay, Bayer Thank you for this very interesting article. From a veterinary medicine perspective, it would certainly explain why such medicines are also experiencing a delay, as veterinary medicines use the same P & A (Pharmaceutical…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2015.0404.044

Editor's Letter

Published on 11 December 2015

Fourth and final issue of GaBI Journal’s fourth volume

This last issue of 2015 starts with a Commentary by Drs Christoph Baumgärtel and Brian Godman concerning the approval of generic versions of narrow therapeutic margin products; including immunosuppressant drugs. The authors explain why they find concerns that have been raised by some clinicians concerning the bioavailability margins needed for approval of narrow therapeutic drugs…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2015.0404.034

Abstract: With many biosimilars being approved around the world, there is an urgent need for clear guidelines on establishing biosimilarity and on approving subsequent extrapolation. The balance between clinical studies and analytics in establishing and confirming biosimilarity are discussed in this paper. Submitted: 28 July 2015; Revised: 15 August 2015; Accepted: 16 August 2015; Published…

Author(s): GaBI Journal Editor

analytics, biosimilarity, clinical studies, extrapolation

DOI: 10.5639/gabij.2015.0404.041

Abstract: Biosimilars have been approved in Europe since 2006. With patents on originator biologicals expiring and ever-tightening healthcare budgets biosimilars are likely to take an increasing share of the biologicals market. In light of these facts, this article gives estimated patent expiry dates for just some of the best-selling biologicals. Submitted: 19 November 2015; Revised:…

Author(s): GaBI Journal Editor

biological, biosimilar, patent

DOI: 10.5639/gabij.2015.0404.040

Introduction: Similar biotherapeutic products (SBPs or biosimilars) include a rapidly expanding number of therapeutic products worldwide. However, agreement about the best practices for their regulation are lacking in many countries including in the Middle East and North Africa (MENA). Methods: The first MENA educational workshop on SBPs was held in Dubai, UAE on 1 September…

Author(s): Professor Philip D Walson, MD, Robin Thorpe, PhD, FRCPath

biologicals, biosimilars, follow-on drugs, MENA (Middle East and North Africa), regulatory practice

DOI: 10.5639/gabij.2015.0404.039

Author byline as per print journal: Michael S Reilly, Esq; Harry L Gewanter, MD, FAAP, FACR Introduction: World Health Organization (WHO) recommendations for the regulation of biosimilars form the basis of guidelines used across most of Latin America. However, the pace at which the region moves toward reaching its potential of having safe and effective biosimilars…

Author(s): Harry L Gewanter, MD, FAAP, FACR, Michael S Reilly, Esq

Biological Qualifier (BQ), biosimilar, Latin America, naming, prescribing, World Health Organization (WHO)

DOI: 10.5639/gabij.2015.0404.036

Submitted: 6 October 2015; Revised: 10 October 2015; Accepted: 12 October 2015; Published online first: 26 October 2015 The most critical safety concern relating to biologicals (including biosimilars) is immunogenicity. This is especially important for monoclonal antibody (mAb) biologicals, which are large molecules with complex structures and functions and which represent the largest class of…

Author(s): GaBI Online Editor

DOI: 10.5639/gabij.2015.0404.043

Abstract: Hybridomas were developed in 1975 as a stable platform for creating monoclonal antibodies (mAbs). Over the past 40 years, hybridomas have been a leading platform for creating mAbs, yet of the 50 commercial mAbs approved for sale by the US Food and Drug Administration (FDA), only 18 are produced using hybridomas. Of the remainder,…

Author(s): Tim Steele, BS

hybridomas, microfluidics, monoclonal antibodies

DOI: 10.5639/gabij.2016.0501.006

Author byline as per print journal: Christoph Baumgärtel, MD, MSc; Brian Godman, BSc, PhD Abstract: Stricter bioequivalence criteria are in place for generics where there are narrow therapeutic indexes such as generic immunosuppressives, enhancing their acceptance despite limited published studies. No serious issues have been reported to date with generic ciclosporin despite being on the market…

Author(s): Brian Godman, BSc, PhD, Christoph Baumgärtel, MD, MSc

bioequivalence, ciclosporin, EMA, generics, immunosuoppressives, narrow therapeutic index drugs

DOI: 10.5639/gabij.2015.0404.035