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

Contents Editor’s Letter What to look forward to in GaBI Journal, 2015, Issue 2 Commentary Pro-generics policies and the backlog in medicines registration in South Africa: implications for access to essential and affordable medicines Original Research Product naming, pricing, and market uptake of biosimilars Differences in pharmacokinetic behaviour of branded enoxaparin and a US generic version in a non-human primate model Pharmaceutical pricing…

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

Abstract: Biosimilars are highly similar versions of reference biological products, some with the potential to be deemed ‘interchangeable’ by regulatory bodies, such as the US Food and Drug Administration. Biosimilar patent litigation continues to evolve as biosimilars enter new global markets. This manuscript takes a look at patent litigation strategies in a more developed biosimilars…

Author(s): Brian J Malkin, Esq

biosimilars, follow-on biological, Inter Partes Review, litigation, opposition, patent

DOI: 10.5639/gabij.2015.0403.026

Editor's Letter

Published on 15 June 2015

What to look forward to in GaBI Journal, 2015, Issue 2

This entire issue of the GaBI Journal could be titled ‘World News’ since it contains manuscripts describing global generics and biosimilar activities. The Commentary by Leng et al. describes regulatory events in South Africa that led to claims of delay in marketing approval of generic drug products. The authors discuss the relationship between regulatory policies…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2015.0402.013

Author byline as per print journal: Robin Thorpe, PhD, FRCPath; Meenu Wadhwa, PhD Abstract: Comment on the Letter to the Editor by Professor Abdol Majid Cheraghali: Access to alternative biopharmaceuticals in low- and middle-income countries, published in GaBI Journal, 2014;4(3):164-5. Submitted: 7 June 2015; Revised: 8 June 2015; Accepted: 8 June 2015; Published online first: 22…

Author(s): Meenu Wadhwa, PhD, Robin Thorpe, PhD, FRCPath

DOI: 10.5639/gabij.2015.0403.024