Abstract: The regulatory oversight of biologicals in Malaysia is established by the National Pharmaceutical Control Bureau (NPCB), Ministry of Health. At the agency, the Section on Biotechnology Product Registration exercises the marketing authorization function as the National Regulatory Authority (NRA). This paper provides an overview of the organization, regulatory expectations and current practices of the…

Author(s): Arpah Abas, BPharm, Yvonne Siew Khoon Khoo, BPharm (Hons) MMedSc, PhD (Pharmacology)

biologicals, evaluation, Malaysia, National Pharmaceutical Control Bureau (NPCB), regulation

DOI: 10.5639/gabij.2014.0304.044

Two countries that were affected by the recent economic recession in different ways, and amended their pharmaceutical policies very differently, have provided researchers with an invaluable data set pointing to the strengths and weaknesses of contrasting pharmaceutical sector policies. The use of antipsychotic medicines across Finland and Portugal following the recession has been analysed in…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2014.0304.049

Abstract: Clinical safety is important during the development of a biosimilar. This paper provides an overview of the main aspects related to the safety assessment of biosimilars. The European Medicines Agency’s ‘Guideline for similar biological medicinal products containing biotechnology-derived proteins as active substances: non-clinical and clinical issues’, which is currently under revision, forms the basis…

Author(s): Christian K Schneider, MD, Thijs J Giezen, PharmD, PhD, MSc

biosimilar, clinical safety, immunogenicity, pharmacovigilance

DOI: 10.5639/gabij.2014.0304.041

Editor's Letter

Published on 05 September 2014

Latest features in GaBI Journal, 2014, Issue 3

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.2014.0303.026

Abstract: The European Medicines Agency (EMA) has led the development of biosimilar regulatory pathways globally, tailoring their approach to meet the specific and scientifically determined needs of biosimilar development. However, the information-driven stepwise approach encouraged by this pathway leading to approval of biosimilar products is only reflected in a single section of the product labelling…

Author(s): European Biopharmaceutical Enterprises

biosimilars, EMA (European Medicines Agency), labels, PIL (product information leaflet), Summary of Product Characteristics (SmPC)

DOI: 10.5639/gabij.2014.0304.043

Abstract: Alternative biopharmaceuticals could substantially improve affordability of biotherapeutics in developing countries. However, it seems that these countries need a modified regulatory pathway to guarantee timely access to these medicines. Submitted: 27 August 2014; Revised: 14 September 2014; Accepted: 15 September 2014; Published online first: 29 September 2013 In recent years, biotherapeutics have gained a…

Author(s): Professor Abdol Majid Cheraghali, PharmaD, PhD

affordability, alternative biopharmaceuticals, regulation

DOI: 10.5639/gabij.2014.0304.038

Aim: To explore whether medicines used in hospitals in European countries are supplied as originators or generic medicines, and to investigate the procurement conditions, including the extent of discounts at which the medicines are provided. Methodology: In September 2009, we collected primary data for four commonly used medicines in 25 public hospitals in five medium-sized…

Author(s): Sabine Vogler, PhD, Nina Zimmermann, MA, Jan Mazag, PharmaDr

cardiovascular medicines, discounts, generics, procurement, rebates, tender

DOI: 10.5639/gabij.2014.0304.040

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

Author byline as per print journal: Gianluca Trifirò, MD, PhD; Meteb Al-Foheidi, MD, FRCPC; Ali M Alhomaidan, PhD; Ahmed H Aljedai, PharmD, MBA, BCPS, FCCP, FAST; Musaed Abdullah Alkholief, PhD; Mohammad A Alsenaidy, MSc, PhD; Aws Alshamsan, BPharm, RPh, PhD; Tore Kristian Kvien, MD, PhD Introduction: A meeting was organized by the Generics and Biosimilars…

Author(s): Ahmed H Aljedai, PharmD, MBA, BCPS, FCCP, FAST, Ali M Alhomaidan, PhD, Assistant Professor Gianluca Trifirò, MD, PhD, Aws Alshamsan, BPharm, RPh, PhD, Meteb Al-Foheidi, MD, FRCPC, Mohammad A Alsenaidy, MSc, PhD, Musaed Abdullah Alkholief, PhD, Professor Tore Kristian Kvien, MD

biologicals, biosimilars, GCC, interchangeability, regulatory, Saudi Arabia

DOI: 10.5639/gabij.2018.0704.032

Author byline as per print journal: Joshua P Cohen, PhD; Abigail E Felix, BA; Kim Riggs, MPH; Anumeha Gupta, MD Background: In the US, a new approval pathway for biosimilars has been established as part of the Affordable Care Act. Biosimilars are anticipated to increase treatment options and lower the growth in spending on biologicals. How the commercial…

Author(s): Abigail E Felix, BA, Anumeha Gupta, MD, Joshua P Cohen, PhD, Kim Riggs, MPH

biosimilar, formulary, interchangeability, originator biological, payers, price discount, therapeutic switching

DOI: 10.5639/gabij.2014.0303.028

Results of a survey carried out by the European Crohn’s and Colitis Organisation (ECCO) highlight a lack of confidence in biosimilars and the need for continued education. The results of the ECCO 2013 survey [1] were presented by Dr Alessandro Armuzzi, together with the EU physician 2013 survey on naming, transparency and traceability for biosimilars…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2014.0303.034

Author byline as per print journal: Brian Godman1,2,3,4, BSc, PhD; Andrew Hill5; Professor Steven Simoens6, MSc, PhD; Amanj Kurdi1,7, BSc, PhD; Jolanta Gulbinovič8, MD, PhD; Antony P Martin2,9; Angela Timoney1,10; Dzintars Gotham11, MBBS; Janet Wale12; Tomasz Bochenek13, MD, PhD; Celia C Rothe13; Iris Hoxha14; Admir Malaj15; Christian Hierländer16; Robert Sauermann16, MD; Wouter Hamelinck17; Zornitza Mitkova18;…

Author(s): Brian Godman, BSc, PhD, Steven Simoens, MSc, PhD

cancer, Europe, generic drug regulations, generics, health policies, pricing

DOI: 10.5639/gabij.2019.0802.007