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

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

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

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

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

Submitted: 10 July 2015; Revised: 13 August 2015; Accepted: 13 August 2015; Published online first: 26 August 2015 Generic medicines can play a role in curbing rising pharmaceutical costs, and therefore the cornerstone of key policies within Organisation for Economic Co-operation and Development (OECD) countries has been to promote the wider use of generics after…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2015.0404.042

Author byline as per print journal: Jon SB de Vlieger, PhD; Professor Stefan Mühlebach, PhD; Vinod P Shah, PhD; Scott E McNeil, PhD; Professor Gerrit Borchard, PharmD, PhD; Vera Weinstein, PhD; Beat Flühmann, PhD; Sesha Neervannan, PhD; Professor Daan JA Crommelin, PhD Abstract: This paper discusses the group of non-biological complex drug (NBCD) products and presents the reasons why…

Author(s): Beat Flühmann, PhD, Daan JA Crommelin, Jon SB de Vlieger, PhD, Professor Gerrit Borchard, PharmD, PhD, Professor Stefan Mühlebach, PhD, Scott E McNeil, Sesha Neervannan, PhD, Vera Weinstein, PhD, Vinod P Shah, PhD

glatiramoids, iron-carbohydrate complexes, liposomes, nanomedicines, non-biological complex drug (NBCD), therapeutic equivalence

DOI: 10.5639/gabij.2015.0404.037

Abstract: There are few challenges to developing effective generics substitution policies in low- and middle-income countries (LMICs). These include the absence of generics substitution policies, lack of enforcement, lack of evidenced-based data about bioequivalence and lack of acceptance by physicians and patients. Submitted: 3 June 2015; Revised: 19 June 2015; Accepted: 24 June 2015; Published…

Author(s): Professor Mohamed Azmi Hassali, PhD, Zhi Yen Wong, BPharm (Hons), MSc (Pharmaceutical Policy), RPh

generic medicines, generics substitution, low- and middle-income countries (LMICs)

DOI: 10.5639/gabij.2015.0404.038

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

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

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: This paper discusses topics covered by the EGA’s April 2015 biosimilars conference, where extrapolation of indications was highlighted as a key issue. Submitted: 2 July 2015; Revised: 15 July 2015; Accepted: 15 July 2015; Published online first: 28 July 2015 The European Generic medicines Association (EGA) held its 13th EGA–European Biosimilars Group Conference in…

Author(s): GaBI Journal Editor

biosimilar, extrapolation, similarity

DOI: 10.5639/gabij.2015.0403.032