Author byline as per print journal: Stephen P Murby, FRSA; Michael S Reilly, Esq Introduction: As the number of biosimilar approvals in Australia increases, it is important to build on the existing regulatory framework to continue to bring high quality, safe and efficacious biosimilars to the widest number of patients most cost-effectively. As new policies regarding […]
Introduction/Study objective: This paper aims to survey the policies implemented by European countries for pricing and promoting the use of biosimilar medicines and to explore similarities and differences with policies for generic medicines. Methods: A literature review was supplemented by primary data collection with policymakers. Members of the Pharmaceutical Pricing and Reimbursement Information (PPRI) network, […]
Author byline as per print journal: Jean-Baptiste Reiland, MSc; Barbara Freischem; Alexander Roediger, MA Introduction/Study objective Biosimilar policies with a focus on uptake have received a lot of attention at national and regional level in the last few years. It is now 10 years since the first biosimilar was approved in the European Union (EU), but […]
Introduction: The US Food and Drug Association (FDA) released its requirements for the non-proprietary naming of biological products in January 2017. Before the FDA’s release, the Alliance for Safe Biologic Medicines (ASBM) asked physicians for their views on the labelling and naming of biosimilar medicines. Study objectives: To determine the opinions of physicians who prescribe […]
Author byline as per print journal: Professor Philip J Schneider, MS, FASHP; Michael S Reilly, Esq Introduction: To date, the US Food and Drug Administration (FDA) has offered only draft guidance on the naming of biosimilar medicines. The Alliance for Safe Biologic Medicines (ASBM) has asked pharmacists for their views on the labelling and naming of […]
Author byline as per print journal: Babar Khan, BPharm, MPH, PhD; Brian Godman, BSc, PhD; Ayesha Babar, BPharm, MPhil; Shahzad Hussain, BPharm, MPhil; Sidra Mahmood, PharmD, MSc; Tahir Aqeel, BPharm, MPhil Introduction: There are concerns over the quality of generic medicines in Pakistan. This is due to perceived non-compliance with good manufacturing practice (GMP), whereby the […]
Author byline as per print journal: Eleftheria Karampli, MSc; Estathia Triga, MSc; Vasiliki Tsiantou, MSc; Kostas Athanasakis, PhD; John Kyriopoulos, PhD Introduction/Study objectives: Generic medicines uptake is widely acknowledged as a key pharmaceutical policy measure towards cost containment and rational resource allocation. In Greece, due to the persistently low penetration of generics in the pharmaceutical […]
Author byline as per print journal: Michael S Reilly, Esq; Harry L Gewanter, MD, FAAP, FACR Introduction: World Health Organization (WHO) recommendations for the regulation of biosimilars form the basis of guidelines used across most of Latin America. However, the pace at which the region moves toward reaching its potential of having safe and effective biosimilars […]
Author byline as per print journal: Steven Kozlowski1, MD; Ellen Tworkoski2, MS, MPhil; Carmen Dekmezian2, MS; Yanchang Zhang2, MPH; Natasha Flowers2, BA; Alvin So3, MS; Andreas M Schick3, PhD; Michael Wernecke2, BA; Thomas MaCurdy2,4, PhD; Jeffrey A Kelman5, MD, MMSc Background: Drug pricing and availability are key concerns for reducing healthcare costs and meeting patient […]
Abstract: With a number of patents on biological medicines soon to expire in the US, multiple stakeholders – from policymakers to manufacturers to payers – have been debating the structure of regulatory frameworks and in particular, naming conventions for biosimilars. A key area of concern has been the potential impact of naming, and specifically, whether […]
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 […]
Objective: One of the questions that the advent of biosimilars raises is whether the different nature of biological medicines would also imply the need for a different policy approach by Member States in the European Union (EU). To assess the policy environment the European Biopharmaceutical Enterprises (EBE) conducted a brief descriptive policy survey of pricing […]
