Abstract: The situation in many countries regarding the procedure used to evaluate ‘biosimilars’ is not always clear. In this issue of GaBI Journal, Azevedo et al. review the regulatory situation for biosimilars in Latin America. It is intended to publish reviews covering the regulatory situation with biosimilars in other countries/geographical areas in future issues of…

Author(s): Robin Thorpe, PhD, FRCPath

biosimilars, follow-on products, Latin America, regulatory processes

DOI: 10.5639/gabij.2014.0303.027

Introduction: The European Union (EU) and the European Medicines Agency (EMA) have led the development of a regulatory framework for biosimilars since 2004. By end of December 2019, 64 biosimilars of 15 originator biological medicines have a marketing authorization in Europe. Now, for the second time, the Alliance for Safe Biologic Medicines (ASBM) asked European…

Author(s): Madelaine A Feldman, MD, FACR, Michael S Reilly, Esq

biological medicines, biosimilar, EU, prescribers, substitution, survey

DOI: 10.5639/gabij.2020.0903.020

Author byline as per print journal: Robin Thorpe, PhD, FRCPath; Elwyn Griffiths, PhD, DSc; Niklas Ekman, PhD Abstract: Biosimilar medicines are being increasingly developed and used worldwide. Many regulatory agencies across the globe are assessing how policy and regulation can be adapted and developed to ensure that biosimilars can enter markets successfully, without affecting the safety…

Author(s): Elwyn Griffiths, DSc, PhD, Niklas Ekman, PhD, Robin Thorpe, PhD, FRCPath

ASEAN, biologicals, biosimilars, education, regulatory, similar biotherapeutic product

DOI: 10.5639/gabij.2018.0703.025

Submitted: 24 May 2016; Revised: 8 June 2016; Accepted: 10 June 2016; Published online first: 24 June 2016 The introduction of biologicals has revolutionized the treatment of immune-mediated diseases such as rheumatoid arthritis (RA) [1]. However, in many countries, patient access to these agents is restricted due to their high costs [2, 3]. Biosimilar drugs…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2016.0502.024

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

Author byline as per print journal: Marta Zuccarelli1, PharmD; Benjamin Micallef1, PharmD; Mark Cilia1, PharmD; Anthony Serracino-Inglott1,2, PharmD; John-Joseph Borg1,3, PhD Introduction/Study Objectives: The development of biosimilars is challenging due to the complexity of the active substances as well as the strict regulatory requirements to show similarity with a reference medicinal product. This review aims…

biosimilars, clinical development programmes, EMA, EPARs, regulatory, safety

DOI: 10.5639/gabij.2021.1002.009

Author byline as per print journal: Jon SB de Vlieger, PhD; Professor Gerrit Borchard, PharmD, PhD; Vinod P Shah, PhD; Beat Flühmann, PhD; Sesha Neervannan, PhD; Professor Stefan Mühlebach, PhD Abstract: Comment on the Regulatory paper by Dr Falk Ehmann and Dr Ruben Pita: The EU is ready for non-biological complex medicinal products, published in…

Author(s): Beat Flühmann, PhD, Jon SB de Vlieger, PhD, Professor Gerrit Borchard, PharmD, PhD, Professor Stefan Mühlebach, PhD, Sesha Neervannan, PhD, Vinod P Shah, PhD

complex drug products, EMA, generics, harmonization, non-biological complex drug (NBCD), therapeutic equivalence, US Food and Drug Administration (FDA)

DOI: 10.5639/gabij.2016.0503.026

Editor's Letter

Published on 11 June 2014

What to look forward to in GaBI Journal, 2014, Issue 2

As mentioned previously, non-biological complex drugs (NBCDs) continue to raise important regulatory and practice issues. This issue of the GaBI Journal contains a number of manuscripts dealing with these products and begins with an update on NCBDs (nanosimilars) developments by Professor Gerrit Borchard. This is followed by a manuscript discussing the use of size and…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2014.0302.015

Author byline as per print journal: Jorge Mestre-Ferrandiz, PhD; Adrian Towse, MA; Mikel Berdud, PhD Abstract: Payers need to think strategically in medium/long term to maximize benefits from biosimilars. Concerns about biosimilars’ interchangeability/substitution (with their reference product) and uncertainty about outcomes act as barriers for their uptake. This paper recommends a policy which provides: (1)…

Author(s): Adrian Towse, MA, Jorge Mestre-Ferrandiz, PhD, Mikel Berdud, PhD

biosimilars, competition, incentives, real world data, savings, value for money

DOI: 10.5639/gabij.2016.0503.027

Abstract: Austria has seen considerable savings with generics, due to its unique pricing system. Generic medicine penetration is, however, not as advanced as in other European countries. Additional savings could be made, provided certain measures are implemented. Submitted: 27 May 2015; Revised: 5 June 2015; Accepted: 8 June 2015; Published online first: 22 June 2015…

Author(s): Christoph Baumgärtel, MD, MSc

Austria, generics, prices

DOI: 10.5639/gabij.2015.0403.030

Submitted: 21 November 2016; Revised: 22 November 2016; Accepted: 24 November 2016; Published online first: 30 November 2016 A study of pharmacists investigated their perceptions of biosimilar naming conventions and the impact it might have on their dispensing habits [1]. The study found that pharmacists had a preference for distinguishable names. However, using the same…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2016.0504.048

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