Editorial
Complex molecules – current developments
Author(s): Professor Gerrit Borchard, PharmD, PhD
Page: 54-5
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… Read More »
Drug shortages hit US oncologists hard
Abstract: The number of drug shortages in the US has tripled between 2006 and 2012, with drug shortages now affecting most US oncologists and impacting on patient care. There… Read More »
Do low- to middle-income countries need a biosimilar approval pathway based on a full comparability exercise?
Author(s): Armando A Genazzani, DPhil, MD, Nicola Magrini, MD
Page: 163-4
Abstract: Despite the fact that hepatitis C is a disease of global importance, many countries cannot afford the costly but effective combination treatment of peg-interferon and ribavirin, which was recently… Read More »
Suggested evaluation of biological drugs role for WHO – Editor’s response
Abstract: The Editor-in-Chief expresses his concerns about the proposal of a WHO run system to approve copy biologicals in the Milani and Gaspani paper [1]. The paper by Milani and… Read More »
Italy’s final position paper on biosimilars and new price and reimbursement pathway
Abstract: The AIFA’s position paper recognizes the relevance of biosimilars to ensure the sustainability of drug expenditure but the new price and reimbursement procedure may not favour their prompt market… Read More »
National and regional activities by sickness funds in Austria to encourage the rational use of medicines
Abstract: Dr Brian Godman reviews the paper by Vogler and Zimmermann on sickness fund activity in Austria to preferentially encourage the prescribing of generics. This is particularly important given the… Read More »
Health authority perspective on biosimilars
Abstract: Dr Brian Godman reviews Mr Gustaf Befrits’ paper on the case for biosimilars from a payer’s perspective. Biosimilars are increasingly important to payers with growing resource pressures. However, key… Read More »
Reference price systems: stakeholder dialogue and involvement
Abstract: Dylst et al. provide a detailed overview about the characteristics of reference price systems in Europe and discuss their possible impact. The role of stakeholders in the implementation of… Read More »
Generics policies–a globally-relevant implementation challenge
Author(s): Andy Gray, MScPharm, FPS, FFIP
Page: 113-4
Abstract: Vogler and Zimmerman, reporting on the 2011 Pharmaceutical Pricing and Reimbursement Information (PPRI) Conference, have noted the incomplete application of generics policies in many settings, and have called for… Read More »
Equal protection under the law: Children and the Best Pharmaceuticals for Children Act
Author(s): Professor Daniel Kelly Benjamin Jr, MD, MPH, PhD, Professor Gregory L Kearns, PharmD, PhD
Page: 54-5
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… Read More »