Submitted: 30 June 2016; Revised: 1 July 2016; Accepted: 1 July 2016; Published online first: 4 July 2016 The European Medicines Agency’s (EMA) decision to approve the use of CPT-13, an infliximab biosimilar, in the treatment of inflammatory bowel disease (IBD), has proven controversial. In two papers, Professor Fernando Gomollón [1, 2] has reviewed and…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2016.0502.022

The world market for medicinal products is expected to reach US$1 trillion in 2014. Global spending on medicines is expected to grow to nearly US$1.2 trillion by 2017 [1]. As governments around the world try to rein in healthcare expenses, generics and biosimilars can play a major role in reducing this budgetary burden. Intellectual property…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2014.0304.046

Author byline as per print journal: Vito Annese, MD; Tommaso Gabbani, MD; Antonio Luca Annese, MD Abstract: The introduction of biological therapy has revolutionized the paradigm of treatment in the last two decades. This is expected to lead to corresponding amelioration of the course of several immune-mediated diseases, including inflammatory bowel diseases (IBD). However, this…

Author(s): Antonio Luca Annese, MD, Tommaso Gabbani, MD, Vito Annese, MD

adalimumab, biosimilar, Crohn’s disease (CD), inflammatory bowel disease (IBD), switching, ulcerative colitis (UC)

DOI: 10.5639/gabij.2016.0503.033

Submitted: 9 January 2013; Revised: 11 January 2013; Accepted: 15 January 2013; Published online first: 22 January 2013 In October 2012, the International Alliance of Patients’ Organizations (IAPO) launched its final Patient-Centred Healthcare Indicators Review and accompanying consultation report [1]. The review forms the initial stage of a wider project being undertaken by IAPO to develop a set of process and outcome…

Author(s): Yasemin Dil

DOI: 10.5639/gabij.2013.0201.005

Introduction: Biosimilars were first introduced in Europe in 2006 and then in the US in 2015. An online webinar on the successful uptake in Europe and the US was held to discuss measures taken for improving biosimilar uptake, and trends in uptake. Methods: The webinar was held by the Alliance for Safe Biologic Medicines (ASBM)…

Author(s): Michael S Reilly, Esq, Professor Philip J Schneider, MS, FASHP, FASPEN, FFIP

biosimilars, health policies, physicians, prescribing, uptake

DOI: 10.5639/gabij.2022.1103.018

Abstract: Differences between the US and European regulatory processes can lead to differences in the time taken for biosimilar approval. The European Medicines Agency is in some cases quicker to approve biosimilar drugs and Europe has overall more approved biosimilars, whilst the US approved the first biosimilar in 2015. Whatever the market, there are a…

Author(s): GaBI Journal Editor

biosimilar, EMA, regulation, US Food and Drug Administration (FDA)

DOI: 10.5639/gabij.2020.0902.015

Submitted: 27 January 2017; Revised: 31 January 2017; Accepted: 1 February 2017; Published online first: 6 February 2017 Previous years have been momentous for biosimilars [1] and 2016 is no exception. This paper highlights the various developments that have taken place during 2016 for biosimilars. Important milestones achieved during 2016 were the biosimilar approvals of…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2017.0601.010

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

Submitted: 24 January 2015; Revised: not applicable; Accepted: 27 January 2015; Published online first: 30 January 2015 The ‘International Generic Drug Regulators Pilot’ (IGDRP) seems to be a true model for the future of authorization processes. It was first founded back in April 2012 with the aim to promote the international collaboration within authorization processes…

Author(s): Christoph Baumgärtel, MD, MSc, DI Dr Katharina Gazda-Pleban

DOI: 10.5639/gabij.2015.0401.011

Many healthcare professionals remain concerned about the safety and efficacy of biosimilars, and are hence reluctant to prescribe them for patients, despite the publication of guidelines for their approval by European regulatory authorities. This level of distrust may reflect a lack of engagement by the regulatory authorities with the medical community during the development of…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2012.0103-4.039

Abstract: The first draft guidelines for copy biologicals were introduced in China back in 2014. The Technical Guideline was then updated and finalized in 2015. In this paper, how the Drug Registration Regulation (2007) pathway classifies therapeutic biologicals and the principles and challenges of the copy biologicals guideline are described. Submitted: 3 May 2018; Revised:…

Author(s): GaBI Journal Editor

biological, China, copy biological, regulation

DOI: 10.5639/gabij.2018.0702.015

Abstract: Biosimilar medicines are having a global effect, and as such regulatory agencies worldwide are assessing how to respond to them. Here, two events held by GaBI for the Colombian medicines regulatory agency (INVIMA) are reported. The first was an educational workshop held in 2016 to discuss approaches to evaluating biosimilar products and the second…

Author(s): Elaine Gray, PhD, Paul Matejtschuk, PhD, CChem, Robin Thorpe, PhD, FRCPath

biologicals, biosimilars, Colombia, quality assessment, regulatory

DOI: 10.5639/gabij.2018.0702.017