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 Gaspani [1] suggests that the World Health Organization (WHO) sets up a programme to approve follow-on pegylated interferons and similar biological medications, that is biological […]
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 access. Submitted: 26 June 2013; Revised: 10 July 2013; Accepted: 11 July 2013; Published online first: 24 July 2013 In the final position paper on […]
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 resources that can be released through increased prescribing of generics. Submitted: 10 June 2013; Revised: 11 June 2013; Accepted: 12 June 2013; Published online first: 20 June 2013 Vogler and Zimmermann have […]
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 issues need addressing to fully capture their benefits. Submitted: 17 January 2013; Revised: 4 February 2013; Accepted: 8 February 2013; Published online first: 11 March 2013 Gustaf Befrits has provided us with […]
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 this policy measure requires further attention. Submitted: 16 September 2012; Revised: 17 September 2012; Accepted: 19 September 2012; Published online first: 21 September 2012 Dylst […]
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 more consistent policies. While many of the basic building blocks of such policies are well described, some elements required renewed attention. Submitted: 23 July 2012; […]
Abstract: Nomenclature for biosimilars is a controversial issue. In this issue of GaBI Journal, a paper by Sarshad et al. considers the US FDA’s published system for this and concludes that it will be a positive solution to a global issue. But this may be a premature judgement. Submitted: 1 January 2019; Revised: 3 January […]
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; […]
Abstract: There are many variables responsible for the pricing of generic medicines in Europe. This editorial looks at the many policy initiatives currently being undertaken. Submitted: 3 November 2011; Revised manuscript received: 23 November 2011; Accepted: 14 December 2011 In this first issue of the Generics and Biosimilars Initiative Journal, Professor Steven Simoens describes the […]
