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

Submitted: 29 January 2019; Revised: 4 February 2019; Accepted: 5 February 2019; Published online first: 14 February 2019 Generic prescription drug prices have been escalating rapidly in the US. In 2014 alone, generic drug prices increased by 38% on average. Public outcry has led to a flurry of recent legislative proposals, and two federal bills…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2019.0802.010

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: As per regulatory requirements, biosimilar drugs must show high similarity to their reference product in quality, preclinical and clinical tests. It is by these means that biosimilars are considered to be safe and efficacious. In India, any major deviation(s) from science-based principles in the manufacturing of a recombinant DNA-derived therapeutic biological product leads to…

Author(s): GR Soni, PhD

biosimilar, CDSCO, Innovator Reference Biological Product, non-innovator biologic, RCGM

DOI: 10.5639/gabij.2020.0901.006

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

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

Abstract: The substantial improvement in the power of analytical methods to compare different versions of a given protein molecule should be taken into account when considering the value of clinical studies for designation of biosimilarity. Arguably, demonstration of comparative pharmacokinetic, allied to post-registration monitoring, will provide more discriminatory clinical evidence than large pre-approval therapeutic equivalence…

Author(s): Frits Lekkerkerker, MD

analytical, biosimilar, comparability, quality, registration, similarity

DOI: 10.5639/gabij.2015.0403.023

Editor's Letter

Published on 16 September 2015

Latest features in GaBI Journal, 2015, Issue 3

This issue of the journal contains a number of manuscripts that discuss proposals to simplify the evaluation of, and therefore decrease the cost of developing, follow-on biological products. These controversial proposals include extrapolation of indications, abbreviated approval processes in resource-poor countries, biological/biosimilar nomenclature, and patent litigation strategies. Dr Frits Lekkerkerker, reviews the paper by Gerrard…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2015.0403.022

Abstract: How to improve the uptake of biosimilars is a question that many countries are finding a challenge. Researchers from the Madrid Health Service investigate how initiatives in Spain have affected biosimilars use. Submitted: 24 March 2016; Revised: 12 May 2016; Accepted: 19 May 2016; Published online first: 1 June 2016 As is the case…

Author(s): GaBI Journal Editor

biological, biosimilar, Spain, uptake

DOI: 10.5639/gabij.2016.0502.021

Abstract: In South Africa, medicines are registered and regulated in terms of the Medicines and Related Substances Control Act (Act 101 of 1965), as amended, and the regulations to this Act. A guideline which outlines the quality, non-clinical and clinical requirements for the registration of a biosimilar medicine was first published in March 2012. This…

Author(s): Khamusi Philip Mutoti, BSc, BPharm Sci, Professor Nontombe Mbelle, MChB, MMed, FC Path (CMSA), Henry MJ Leng, PhD

biosimilars, comparative studies, registration requirements

DOI: 10.5639/gabij.2015.0403.033