The ethics of biosimilars
Journal Title: Generics and Biosimilars Initiative Journal - Year 2013, Vol 2, Issue 1
Abstract
Comment on the Letters to the Editor by Dr Carlo Petrini: A bioethicist’s view of the use of biosimilars, published in GaBI Journal, 2012, issue 3-4.
Authors and Affiliations
Christian K Schneider
Biosimilar development and regulation in Japan
In Japan, biosimilars guidelines following the principles of the EU framework were established by Japan’s Ministry of Health, Labor and Welfare in March 2009. The guidelines cover the manufacturing process, characterizat...
Pharmacokinetics of antimicrobials in obese children
Introduction: Childhood obesity is common and results in substantial morbidity. The most commonly prescribed drugs in obese children are antibiotics. However, physiological changes associated with childhood obesity can a...
Reference pricing systems in Europe: characteristics and consequences
Introduction: A reference pricing system is a system that establishes a common reimbursement level or reference price for a group of interchangeable medicines, i.e. the reference group. This article provides an overview...
Critical immunogenicity differences will be obscured by a common INN for biosimilars
Information about variable immunogenicity arising from formulation differences between competing biosimilars is critical for informed judgments by prescribing physicians. Use of a common INN for biosimilars will obfuscat...
Italy’s final position paper on biosimilars and new price and reimbursement pathway
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.