Submitted: 3 February 2020; Revised: 12 February 2020; Accepted: 18 February 2020; Published online first: 25 February 2020 2019 has been a busy year for biosimilars; there have been a record number of approvals and the start of many clinical trials. It has been a particularly busy year for the oncology and anti-inflammatory therapeutic areas, with…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2020.0901.007

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

Author byline as per print journal: Josette Sciberras, MBA, MA Bioethics, BPharm (Hons); Raymond Zammit, SThD; Patricia Vella Bonanno, PhD Introduction: The Pharmaceutical Strategy for Europe (2020) proposes actions related to intellectual property (IP) rights as a means of ensuring patients’ access to medicines. This review aims to describe and discuss the European IP framework and…

biological medicines, European intellectual property rights, market access, pricing, R & D

DOI: 10.5639/gabij.2021.1004.022

Abstract: The pharmacological activity and toxicity of non-biological complex drugs (NBCDs) depends on their complex structure and composition. The regulatory approach leading to the registration of such drugs and their follow-on products, deemed ‘nanosimilars’, must be based on emerging scientific knowledge of NBCD properties determining their in vivo fate. Submitted: 8 April 2014; Revised: 11…

Author(s): Professor Gerrit Borchard, PharmD, PhD

nanomedicines, nanosimilars, non-biological complex drug (NBCD), regulatory

DOI: 10.5639/gabij.2014.0302.016

Author byline as per print journal: Arianna Bertolani, PhD; Claudio Jommi, MS Study Objectives: Different policies have been implemented to enhance uptake of biosimilars. Regarding policies focussing on the demand-side, the literature has mainly concentrated on interchangeability and substitutability recommendations, issued by national or regional policymakers. Information on actions taken by healthcare organisations (HCOs) regarding…

Author(s): Arianna Bertolani, PhD, Claudio Jommi, MS

biosimilars, Italian national health service, local policies

DOI: 10.5639/gabij.2020.0904.027

Author byline as per print journal: Pieter J Glerum1,2, MSc; Mert Hayta1,3, PharmD, MSc; David M Burger4, PharmD, PhD; Cees Neef5, PharmD, PhD; Marcel L Bouvy3, PharmD, PhD; Marc Maliepaard1,6, PhD Background: Drug switching describes switching between drug products with the same active substance. Drug switching occurs commonly in the Netherlands and mostly between generic drug…

Brand-name drugs, drug switching, generic drugs, generics substitution, interchangeability, pharmacy practice

DOI: 10.5639/gabij.2021.1003.014

Abstract: The development of biological medicinal products is in rapid growth and as patents for reference products expire, new biosimilar products become available. This has a marked impact on several stakeholders; from patients and physicians to decision-makers, and on activities; from treatment of patients to the conduct of pharmacovigilance. The Danish Medicines Agency (Laegemiddelstyrelsen, DKMA)…

Author(s): Benedicte Lunddahl, DVM

biological medicinal products, biosimilars, national competent authority, pharmacovigilance

DOI: 10.5639/gabij.2016.0503.030

Author byline as per print journal: Adjunct Associate Professor Sia Chong Hock1, BSc (Pharm), MSc; Adelia Pheh1, BSc (Pharm) (Hon); Vimal Sachdeva2, MSc; Associate Professor Chan Lai Wah1, BSc (Pharm) (Hon), PhD Abstract: Since the onset of the COVID-19 pandemic, there has been a significant surge in interest of COVID-19 vaccines in particular, and other…

challenges, COVID-19 vaccines, harmonization, manufacturing, regulation, traditional vaccines

DOI: 10.5639/gabij.2022.1101.004

Author byline as per print journal: Rieke Alten1, MD, PhD; Herbert Kellner2, MD; Malcolm Boyce3, MD; Takuma Yonemura4, MD; Takahiro Ito5, MSc; Mark C Genovese6, MD Introduction/Study objectives: FKB327 is a biosimilar of the adalimumab reference product. Studies in healthy subjects and patients with rheumatoid arthritis demonstrated biosimilarity between FKB327 and the reference product in…

adalimumab, anti-TNF therapy, biosimilars, clinical trials, injection-site pain, rheumatoid arthritis

DOI: 10.5639/gabij.2020.0903.019

Abstract: As a practicing endocrinologist and Chairman of the Alliance for Safe Biologic Medicines, I am writing to commend the World Health Organization for its attention to and upcoming action on the important issue of non-proprietary names for biotech medicines. Submitted: 20 September 2013; Revised: 21 September 2013; Accepted: 21 September 2013; Published online first:…

Author(s): Richard O Dolinar, MD

biological identification, INN, public safety, World Health Organization (WHO)

DOI: 10.5639/gabij.2013.0204.047

Editor's Letter

Published on 14 November 2012

Latest features in GaBI Journal, 2012, issue 3-4

This issue of the GaBI Journal uses a number of article formats to cover a range of issues related to generics and biosimilars. In Letters to the Editor, Dr Carlo Petrini presents and defends the suggestion that the clinical use of biosimilars poses ethical concerns that differ from those of other pharmaceutical products. He even…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2012.0103-4.037

Abstract: Biosimilars policies are more controversial than those for generics. However, it is only a question of time before progress in biosimilars matches that of generics worldwide. Submitted: 21 April 2017; Revised: 28 April 2017; Accepted: 2 May 2017; Published online first: 15 May 2017 Healthcare systems worldwide are under increasing pressure due to the…

Author(s): Alessandro Curto, MSSc

biosimilars, Europe, pricing, reimbursement

DOI: 10.5639/gabij.2017.0602.012