Abstract: Biosimilar products confront novel market authorization and post-marketing use hurdles. Existing evidence is insufficient to fully address physician and payer acceptability thresholds. Submitted: 4 March 2015; Revised: 5 March 2015; Accepted: 9 March 2015; Published online first: 20 March 2015 In this issue of GaBI Journal, Sandorff et al. [1] investigate payer and physician…

Author(s): Professor Alan Lyles, BSPharm, MPH, ScD, PhD (h.c.)

acceptability, biologicals, biosimilars, interchangeability, pricing

DOI: 10.5639/gabij.2015.0401.002

Submitted: 5 February 2019; Revised: 14 March 2019; Accepted: 20 March 2019; Published online first: 2 April 2019 The global market for biosimilars is valued at approximately US$4 billion, and it is growing rapidly as patents expire on an increasing number of biological drugs. A number of important milestones were achieved during 2018 regarding approval…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2019.0801.004

A recent study by IMS Health Austria (IMS) revealed that in Austria healthcare payers could have saved more than a quarter billion Euros during 2011 if physicians would have prescribed more generics to their patients. The total reimbursed medicines market in Austria totals Euros 1.89 billion. IMS estimates that 89% of the total market by…

Author(s): Christoph Baumgärtel, MD, MSc

DOI: 10.5639/gabij.2012.0103-4.038

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 product approvals continues to grow, it will become even more important to collect pharmacovigilance data that are accurate and attributable to the specific product. Different…

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

Author byline as per print journal: Professor Francisco José de Abajo, MD, MPH, PhD; Professor Joan Albanell, MD; Olga Delgado Sanchez, PharmD; Kevin Klein, MSc; José Vicente Moreno-Muelas, MD; Sol Ruiz, PhD; Professor Maria Jesús Sanz Ferrando, PhD; Robin Thorpe, PhD, FRCPath; Professor Francisco Zaragozá, PhD Introduction: Biosimilars can offer a lower-cost alternative to current biological therapies and could…

Author(s): José Vicente Moreno-Muelas, MD, Kevin Klein, PhD, Olga Delgado Sanchez, PharmD, Professor Francisco José de Abajo, MD, MPH, PhD, Professor Francisco Zaragozá, PhD, Professor Joan Albanell, MD, Professor Maria Jesús Sanz Ferrando, PhD, Robin Thorpe, PhD, FRCPath, Sol Ruiz, PhD

biologicals, immunogenicity, interchangeability, pharmacovigilance, Spain, traceability

DOI: 10.5639/gabij.2017.0601.007

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

Author byline as per print journal: Professor Philip J Schneider1, MS, FASHP, FASPEN, FFIP; Michael S Reilly2, Esq Canada has approved a total of 36 biosimilars. While the approval of biosimilars is regulated at the national level, decisions about biosimilar substitution are made at the provincial level. Four Canadian provinces, representing around 50% of the…

Author(s): Michael S Reilly, Esq, Professor Philip J Schneider, MS, FASHP, FASPEN, FFIP

biosimilars, Canada, policy, substitution, switching

DOI: 10.5639/gabij.2021.1003.016

Author byline as per print journal: Ka-Liong Tan1, DPhil; Ainoon Othman1; Irwan Mohd Subri2,3; Noor Fadzilah Zulkifli1; Mohd Mahyeddin Mohd Salleh3; Nazariyah Yahaya4; Khairun Nain Nor Aripin1; Shahirah Nadiah Shaharuddin5; Seri Azalina Mohd Ghazalli6; Muhammad Syazan Sulaiman6 Abstract: In recent years, there has been a rapid growth of the halal pharmaceutical industry, especially in the…

halal assurance, halal pharmaceuticals, oral dosage, supply chain

DOI: 10.5639/gabij.2023.1203.014

Abstract: This paper discusses the findings and summary of items covered in the First Turkish interactive workshop on regulation and approval of similar biotherapeutic products/biosimilars, in which structure–function was highlighted as a key issue. Submitted: 4 June 2016; Revised: 7 September 2016; Accepted: 15 September 2016; Published online first: 28 September 2016 Introduction This interactive…

Author(s): Professor Philip D Walson, MD, Robin Thorpe, PhD, FRCPath

glycosylation, immunogenicity, potency, receptor binding, serum half-life, sialic acid

DOI: 10.5639/gabij.2016.0503.034

Abstract: This paper discusses topics covered by the EGA’s April 2015 biosimilars conference, where extrapolation of indications was highlighted as a key issue. Submitted: 2 July 2015; Revised: 15 July 2015; Accepted: 15 July 2015; Published online first: 28 July 2015 The European Generic medicines Association (EGA) held its 13th EGA–European Biosimilars Group Conference in…

Author(s): GaBI Journal Editor

biosimilar, extrapolation, similarity

DOI: 10.5639/gabij.2015.0403.032

Meeting Report

Published on 14 September 2023

Medicare drug price negotiations: impact on healthcare development and patient access to medicines

Author byline as per print journal: Michael S Reilly, Esq; Thomas R Barker, Esq, JD; Charles M Clapton, Esq; Steven J Potts, PhD, MBA; Andrew Spiegel, Esq Introduction: In the US, a Medicare drug price negotiation provision has been introduced in the form of the 2022 Inflation Reduction Act (IRA). An online webinar on the…

DOI: 10.5639/gabij.2023.1203.015

Author byline as per print journal: Barbara OM Claus, PharmD, PhD; Tiene Bauters, PharmD, PhD; Annemie Somers, PharmD, PhD Abstract: In the coming decade, many patents for biological pharmaceuticals will expire. Consequently, the market for biosimilars has the potential to grow rapidly. For safety reasons, the more extensive use of a greater variety of biologicals increases…

Author(s): Barbara OM Claus, PharmD, PhD, Professor Annemie Somers, PharmD, PhD, Tiene Bauters, PharmD, PhD

biologicals, biosimilars, hospitals, pharmacovigilance

DOI: 10.5639/gabij.2017.0601.005