Abstract: Chemotherapy-induced anaemia can be treated using erythropoiesis-stimulating agents (ESAs), but these can cause serious side-effects including tumour progression, venous thromboembolism, and shorter survival. Following extensive review of recent literature, the American Society of Clinical Oncology and the American Society of Hematology have updated their guidelines on the use of ESAs. New recommendations include minimising…

Author(s): GaBI Journal Editor

chemotherapy-induced anaemia, darbopoetin, epoetin, erythropoetin-stimulating agents, haemoglobin, thromboembolism

DOI: 10.5639/gabij.2013.0202.018

Author byline as per print journal: Mario R Sampson, PharmD; Michael Cohen-Wolkowiez, MD, PhD; Professor Daniel Kelly Benjamin Jr, MD, MPH, PhD; Edmund V Capparelli, PharmD; Kevin M Watt, MD Introduction: Childhood obesity is common and results in substantial morbidity. The most commonly prescribed drugs in obese children are antibiotics. However, physiological changes associated with…

Author(s): et al., Mario R Sampson, PharmD

antimicrobial agents, obesity, paediatric, pharmacokinetics

DOI: 10.5639/gabij.2013.0202.025

Abstract: The lack of clear regulatory guidance remains a key bottleneck for securing a second quality-assured source of liposomal amphotericin B (LAmB), the WHO-recommended drug for visceral leishmaniasis. The approval of the first generic liposomal product by the US Food and Drug Administration in February 2013 could be a turning point, and serve as a…

Author(s): Barbara Milani, Sara Gaspani

drug access, generics, liposomal amphotericin B, liposomal doxorubicin, visceral leishmaniasis

DOI: 10.5639/gabij.2013.0202.022

Abstract: In 2010, the Council of the European Society for Organ Transplantation formed an Advisory Committee to formulate recommendations on the use of generic drugs in solid organ transplant recipients. The initiative was taken as a result of concerns regarding generic substitution of immunosuppressive drugs. The recommendations were published in Transplant International, and this paper…

Author(s): Professor Teun van Gelder, MD, PhD

ciclosporin, generics substitution, immunosuppression, mycophenolate, tacrolimus, transplantation

DOI: 10.5639/gabij.2013.0203.031

Author byline as per print journal: Tobias Blank, PhD, Tilo Netzer, PhD, Wolfram Hildebrandt, MSc, MA, Angela Vogt-Eisele, PhD, Professor Marietta Kaszkin-Bettag, PhD Background: As patents for biological drugs begin to expire, the need for scientific guidance on biosimilar drugs grows increasingly important. The European Medicines Agency provided the first guidelines to cover the approval…

Author(s): Angela Vogt-Eisele, PhD, Professor Marietta Kaszkin-Bettag, PhD, Tilo Netzer, PhD, Wolfram Hildebrandt, MSc, MA, Tobias Blank, PhD

biosimilar regulation, biosimilar safety (EU USA), biosimilar toxicity, immunogenicity, pharmacovigilance, traceability

DOI: 10.5639/gabij.2013.0203.039

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

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

Introduction: The number of biosimilars, or similar biotherapeutic products, is expanding rapidly worldwide. A further 12 blockbuster biologicals are set to add to this number by 2020. Agreement about the best practices for the regulation, use, interchangeability and pharmacovigilance of biosimilars is lacking in many countries including in the Middle East and North Africa (MENA).Methods:…

Author(s): Andrea Laslop, MD, Jian Wang, MD, PhD, Robin Thorpe, PhD, FRCPath

biosimilars, costs, MENA (Middle East and North Africa), pharmacovigilance, regulators, switching

DOI: 10.5639/gabij.2019.0802.009

Author byline as per print journal: Shih-Ting Chiu, PhD, Chen Chen, MSc, Professor Shein-Chung Chow, PhD, Eric Chi, PhD Introduction: For generic approval of small-molecule (chemical) drug products, US Food and Drug Administration requires evidence of equivalence in average bioavailability from bioavailability and bioequivalence studies. To address drug interchangeability, population bioequivalence (PBE) for drug prescribability…

Author(s): et al., Shih-Ting Chiu, MSc

extra-reference design, generalized pivotal quantity, individual bioequivalence, replicated crossover design

DOI: 10.5639/gabij.2013.0203.037

Author byline as per print journal: Alessandro Curto, MSSc, Katelijne Van de Vooren, MSc, Roberta Lo Muto, MSc, Silvy Duranti, MBA, Professor Livio Garattini Introduction: Health care in Italy is mainly delivered through the country’s National Health Service (NHS), a public service funded by general taxation. The system is highly decentralized and each one of…

Author(s): Alessandro Curto, MSSc, Katelijne Van de Vooren, MSc, Professor Livio Garattini, Roberta Lo Muto, MSc, Silvy Duranti, MBA

biosimilars, competition, Italy, regions, tender

DOI: 10.5639/gabij.2013.0203.036

Abstract:  The European Organisation for Research and Treatment of Cancer (EORTC) has updated its 2006 guideline on the use of granulocyte colony-stimulating factor (G-CSF) for the prevention of febrile neutropenia (FN), a sometimes fatal condition in which a loss of neutrophils in patients receiving chemotherapy leads to infections and fever. The guideline provides recommendations on…

Author(s): GaBI Journal Editor

febrile neutropenia, G-CSF, leukaemia, lymphoma, myelosuppression, risk

DOI: 10.5639/gabij.2013.0201.016

Editor's Letter

Published on 19 April 2013

Editor’s introduction to the wide range of topics in the initial issue of the second volume of GaBI Journal

We start off the second year of GaBI Journal with articles covering a wide range of issues. In Letters to the Editor, Dr Christian K Schneider discusses and expands on a previously published article by a bioethicist [1] on the ethics of biosimilars. Dr Schneider applauds the inclusion of ethicists in the debates concerning biosimilars…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2013.0201.015