Articles

Review Article

Published on 28 May 2013

The need for distinct nomenclature for originator and biosimilar products

Author byline as per print journal: Michael Sarshad, BSc, MBA; Rosanne Campbell, BComm, PGdip, MSc; Peter J Pitts, BA; Jacqueline anderpuye- Orgle, MSc, PhD Abstract: As the number of biosimilar...

Author(s): Jacqueline Vanderpuye-Orgle, MSc, PhD, Michael Sarshad, BSc, MBA, Rosanne Campbell, BComm, PGdip, MSc, Peter J Pitts, BA

biosimilars, Inflectra, International Nonproprietary Name (INN), naming, nomenclature, Zarxio

DOI: 10.5639/gabij.2018.0704.031

8.560 views

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Guidelines

Published on 06 May 2013

Update on clinical practice guideline on the use of epoetin and darbepoetin in adult patients with cancer

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,...

Author(s): GaBI Journal Editor

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

DOI: 10.5639/gabij.2013.0202.018

6.684 views

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Letters to the Editor

Published on 30 April 2013

Access to liposomal generic formulations: beyond AmBisome and Doxil/Caelyx

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...

Author(s): Barbara Milani, Sara Gaspani

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

DOI: 10.5639/gabij.2013.0202.022

42.676 views

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Commentary

Published on 24 April 2013

Commentary on the recommendations of the European Society for Organ Transplantation Advisory Committee on generic substitution of immunosuppressive drugs

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....

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

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

DOI: 10.5639/gabij.2013.0203.031

23.628 views

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Review Article

Published on 24 April 2013

Safety and toxicity of biosimilars—EU versus US regulation

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...

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

35.303 views

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Regulatory

Published on 24 April 2013

Biosimilar development and regulation in Japan

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...

Author(s): GaBI Journal Editor

biosimilar, Japan, regulatory

DOI: 10.5639/gabij.2013.0204.055

17.277 views

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Review Article

Published on 24 April 2013

Understanding the components of pharmaceutical expenditure—overview of pharmaceutical policies influencing expenditure across European countries

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...

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

63.455 views

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Meeting Report

Published on 06 August 2019

2nd MENA Stakeholder Meeting on Biosimilars 2018 – Report

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...

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

11.240 views

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Original Research

Published on 24 April 2013

Assessing biosimilarity using the method of generalized pivotal quantities

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...

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

26.685 views

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