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

Objective: To analyse similarities and differences between activities carried out by Austrian sickness funds to encourage more rational use of medicines, including increasing generics uptake. Methods: Semi-structured interviews with pharmacoeconomic unit staff of four regional sickness funds in Austria. Results: Sickness funds include a variety of activities. The main target group is prescribers, who are…

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

generics, generics uptake, medicines, monitoring, prescribing, rational use of medicines, sickness funds

DOI: 10.5639/gabij.2013.0202.027

Author byline as per print journal: Andrew Mica, MBA, Martha Mutomba, PhD, Larry Green, PharmD Introduction: When drug shortages occur, healthcare providers (HCPs) often must ration drugs, cancel or delay treatments, or utilize alternative drugs that may be less efficacious and/or are associated with increased risk of adverse outcomes, potentially impacting patient care. The likelihood…

Author(s): Andrew Mica, MBA, et al.

biological, drug shortages, healthcare provider, manufacturing, supply chain

DOI: 10.5639/gabij.2013.0203.038

Abstract: The advent of similar biological medicinal products or ‘biosimilars’ in Europe in the 2000s has led to development of a global biosimilars market and regulatory frameworks designed specifically for approval of biosimilars. Like originator biologicals, biosimilars exhibit greater molecular complexity than small-molecule drugs, including generics. Current estimates suggest that biosimilars are more expensive and…

Author(s): James N Class, PhD, Lauren Langis, JD

biosimilars, medical devices, outcomes, patients, prescribers, public policy

DOI: 10.5639/gabij.2012.0101.006

Author byline as per print journal: Helle Håkonsen, MScPharm, PhD; Else-Lydia Toverud, MScPharm, PhD Introduction: With a few exceptions, generic drug use has been promoted in western countries by allowing pharmacists to substitute drugs defined as therapeutically equivalent generics. The aim of this literature review is to summarise the research on the patients’ perspectives of generics substitution…

Author(s): Else-Lydia Toverud, MScPharm, PhD, Helle Håkonsen, MScPharm, PhD

cost containment, generic drugs, generics prescribing, generics substitution, patient perspectives

DOI: 10.5639/gabij.2012.0101.008

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

Author byline as per print journal: Professor Shein-Chung Chow, PhD, Christine Ju, MSc Abstract: Biological (large molecule) drug products are made via living systems and are complex and variable in nature. As a result, generic forms of biological products, also termed biosimilars in the EU or follow-on biologics by the US Food and Drug Administration, can…

bioequivalence, biosimilarity, BPCIA, follow-on biologics, interchangeability

DOI: 10.5639/gabij.2013.0201.004

Abstract:  Four changes to the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act will markedly improve these programmes: expanded attention paid to neonatal studies, support for the off -patent programme, timing and submission of paediatric plans, and the per­manence of the legislation. Submitted: 30 November 2011; Revised manuscript received: 2 March 2012;…

Author(s): Professor Daniel Kelly Benjamin Jr, MD, MPH, PhD, Professor Gregory L Kearns, PharmD, PhD

Best Pharmaceuticals for Children Act, clinical studies, legislation, neonates, off-patent drugs

DOI: 10.5639/gabij.2012.0102.014

Author byline as per print journal: Barbara Milan, Sara Gaspani Introduction: The current pipeline of promising oral hepatitis C drugs could lead to a revolution in treatment for this disease in both developed and developing countries. At present, the recommended treatment is pegylated interferon alpha (in combination with ribavirin). However, the limited availability and high…

Author(s): Barbara Milani, Sara Gaspani

biosimilars, competition, drug regulation, hepatitis C, pegylated interferon alpha, prices

DOI: 10.5639/gabij.2013.0204.053

Abstract:  A number of generic products containing clopidogrel as the active substance have been marketed in Austria and the EU for some time. Due to different clopidogrel salt preparations and different indications, doubts arose as to whether the products could be considered as equivalent. The Austrian Federal Office for Safety in Health Care (BASG)/The Austrian Agency for Health and Food Safety…

Author(s): Christoph Baumgärtel, MD, MSc

bioequivalence, clopidogrel, drug substitution, drugs, generics, therapeutic equivalence

DOI: 10.5639/gabij.2012.0102.019

Author byline as per print journal: Ljiljana Sović Brkičić, MPharm; Brian Godman, BSc, PhD; Martina Bogut, BSc; Miron Sršen, MD; Hye-Young Kwon, BPharm, MPH, PhD; Winnie de Bruyn, BSc; Tonko Tabain, MD Introduction: Croatia has introduced a number of reforms to contain pharmaceutical expenditure whilst increasing access to new medicines. These include new regulations and new…

Author(s): Brian Godman, BSc, PhD, Hye-Young Kwon, BPharm, MPH, PhD, Ljiljana Sović Brkičić, MPharm, Martina Bogut, BSc, Miron Sršen, MD, Tonko Tabain, MD, Winnie de Bruyn, BSc

biosimilars, Croatia, generics, pharmaceuticals, reference pricing system, reforms

DOI: 10.5639/gabij.2015.0402.017

Author byline as per print journal: Brian Godman1,2,3, BSc, PhD; Mohammed Abuelkhair4, PharmD; Agnes Vitry5, PharmD, PhD; Shajahan Abdu4, MD; Marion Bennie6,7, MSc; Iain Bishop7, BSc; Sahar Fahmy4, PhD; Kristina Garuoliene8, MD, PhD; Harald Herholz9, MPH; Andrew Martin10, BSc, MPharmS; Rickard E Malmstrom11, MD, PhD; Professor Saira Jan12,13, PharmD, PhD; Ulrich Schwabe14, MD, PhD; Catherine Sermet15,…

Author(s): Brian Godman, BSc, PhD, et al.

demand-side measures, generics, pharmaceuticals, pricing

DOI: 10.5639/gabij.2012.0102.017