Abstract: Two biosimilar TNF-alfa monoclonal antibody (mAb) products were approved for clinical use in the European Union on 10 September 2013, following a positive opinion by the Committee for Medicinal Products for Human Use (CHMP) in July 2013. The products, with trade names Remsima and Inflectra (INNs infliximab) contain an identical mAb. This approval shows…

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

biosimilar, EPAR, infliximab, monoclonal antibodies

DOI: 10.5639/gabij.2014.0301.004

Submitted: 24 January 2014; Revised: 29 January 2014; Accepted: 30 January 2014; Published online first: 12 February 2014 To the Editor: I read with interest the letter of Dr Edward T Maggio which was published in Volume 2/Year 2013/Issue 4 of the Generics and Biosimilars Initiative Journal [1] on the naming issue for biosimilars and…

Author(s): Professor Paul J Declerck, PhD

DOI: 10.5639/gabij.2014.0301.003

  Abstract: The number of drug shortages in the US has tripled between 2006 and 2012, with drug shortages now affecting most US oncologists and impacting on patient care. There is a need for new guidelines to control drug substitutions and to single out priority populations for relatively scarce drugs. The very real threat of…

Author(s): GaBI Journal Editor

5FU, clinical trials, drug shortages, legislation, oncologists

DOI: 10.5639/gabij.2014.0301.002

Editor's Letter

Published on 18 March 2014

Editor’s introduction to the initial issue of the third volume of GaBI Journal

This issue of the GaBI Journal begins with editorial comments from our Deputy Editor-in-Chief Dr Robin Thorpe concerning the Review Article by Azevedo et al. covering biosimilar regulations and their implementation in some Latin American countries. Three Original Research papers describe real life clinical examples relating to the use and evaluation of follow-on products respectively;…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2014.0301.001

Abstract: In Japan, biosimilars guidelines following the principles of the EU framework were established by Japan’s Ministry of Health, Labor and Welfare in March 2009. The guidelines cover the manufacturing process, characterization of quality attributes, and clinical and non-clinical studies for biosimilars. In this paper, the requirements for regulatory approval of biosimilars in Japan are…

Author(s): GaBI Journal Editor

biosimilar, Japan, regulatory

DOI: 10.5639/gabij.2013.0204.055

Author byline as per print journal: Professor Stefan Mühlebach, PhD, Professor Arnold Vulto, PharmD, PhD, Jon SB de Vlieger, PhD, Vera Weinstein, PhD, Beat Flühmann, PhD, Vinod P Shah, PhD Introduction: Besides biologicals, a new class of complex drugs – non-biological complex drugs (NBCDs), e.g. liposomes, iron carbohydrate products and glatiramoids – has emerged. Originator…

Author(s): Beat Flühmann, PhD, Jon SB de Vlieger, PhD, Professor Arnold G Vulto, PharmD, PhD, FCP, Professor Stefan Mühlebach, PhD, Vera Weinstein, PhD, Vinod P Shah, PhD

glatiramoids, iron sucrose, liposomes, nanomedicines, non-biological complex drug (NBCD), similars

DOI: 10.5639/gabij.2013.0204.054

Author byline as per print journal: Barbara Milan, Sara Gaspani Introduction: The current pipeline of promising oral hepatitis C drugs could lead to a revolution in treatment for this disease in both developed and developing countries. At present, the recommended treatment is pegylated interferon alpha (in combination with ribavirin). However, the limited availability and high…

Author(s): Barbara Milani, Sara Gaspani

biosimilars, competition, drug regulation, hepatitis C, pegylated interferon alpha, prices

DOI: 10.5639/gabij.2013.0204.053

Abstract: Biosimilar monoclonal antibodies (mAbs) are making their way onto the drug market. Because these are complex molecules in terms of structure and function, assessing similarity between originator and biosimilar mAb is challenging. This review discusses the hallmarks of similarity testing between originator products and mAb biosimilars in terms of product quality attributes, non-clinical and…

Author(s): Vera Brinks, MSc, PhD

biosimilar monoclonal antibodies, immunogenicity, similarity assessment

DOI: 10.5639/gabij.2013.0204.052

Aim: To explain the components of pharmaceutical expenditure and illustrate the strengths and limitations of this indicator. In particular, we explore policies applied in European countries that affect the price and volume of medicines. Methodology: This paper is based on a presentation held at the European Drug Utilization Research Group (EuroDURG)/International Society for Pharmacoepidemiology (ISPE)…

Author(s): Claudia Habl, Sabine Vogler, PhD, Nina Zimmermann, MA

health expenditures, hospital sector, medicine prices, pharmaceutical expenditure, policy, volume

DOI: 10.5639/gabij.2013.0204.051

Author byline as per print journal: Aijing Zhang, PhD, Associate Professor Jung-Ying Tzeng, Professor Shein-Chung Chow, PhD Abstract: When an innovative biological product goes off-patent, biopharmaceutical or biotechnological companies may file an application for regulatory approval of biosimilar products. In practice, however, important information on the innovative (reference) product may not be available for assessment. Thus,…

biosimilarity, biosimilarity index, highly similar, reference standards, replicate reference study

DOI: 10.5639/gabij.2013.0204.050

Abstract: Biological product quality is susceptible to unexpected manufacturing issues, and the resulting variation may impact the safety or efficacy of these medicines and increase risks to patients. These risks can be managed more effectively by manufacturers’ adoption of the culture and practices of high reliability organizations and by their sharing of quality risk management…

Author(s): Gustavo Grampp, PhD, Sundar Ramanan, PhD

biologicals, manufacturing, quality, safety

DOI: 10.5639/gabij.2013.0204.049

Submitted: 31 October 2013; Revised: 6 November 2013; Accepted: 11 November 2013; Published online first: 25 November 2013 To the Editor: I wanted to bring to your attention the following paper which was published in Volume 2/Year 2013/Issue 3 of the Generics and Biosimilars Initiative Journal. The Perspective paper titled Licensing and prescribing biosimilars in…

Author(s): Brendan Shaw, PhD

DOI: 10.5639/gabij.2013.0204.048